Trial Outcomes & Findings for Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes (NCT NCT02477605)

Last Updated: 2018-07-02

Results Overview

IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.

Recruitment status

COMPLETED

Study phase

Target enrollment

137 participants

Primary outcome timeframe

Day 0 preoperative, Day 0 postoperative

Results posted on

2018-07-02

Participant Flow

Subjects were recruited from 6 study centers located in the US.

Of the 137 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (136).

Participant milestones

Participant milestones
Measure	27-Gauge CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	23-Gauge CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
Overall Study STARTED	68	68
Overall Study Randomized and Treated	67	68
Overall Study COMPLETED	67	64
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	27-Gauge CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	23-Gauge CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
Overall Study Discontinued prior to treatment	1	0
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	0	1
Overall Study Administered gas during surgery	0	1

Baseline Characteristics

Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	27-Gauge n=68 Participants CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	23-Gauge n=68 Participants CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery	Total n=136 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 11.55 • n=5 Participants	67.0 years STANDARD_DEVIATION 11.65 • n=7 Participants	66.4 years STANDARD_DEVIATION 11.57 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 preoperative, Day 0 postoperative

Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.

Outcome measures

Outcome measures
Measure	27-Gauge n=67 Participants CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	23-Gauge n=68 Participants CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
Mean Change in Intraocular Pressure (IOP) on Operative Day	-0.40 mmHG Standard Deviation 6.603	-3.05 mmHG Standard Deviation 7.639

SECONDARY outcome

Timeframe: Week 1 post operative

Population: Intent-to-Treat Set. Number Analyzed is the number of subjects with data.

Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.

Outcome measures

Outcome measures
Measure	27-Gauge n=67 Participants CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	23-Gauge n=67 Participants CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
Mean Conjunctival Edema Score at Week 1	0.02 units on a scale Standard Deviation 0.124	0.10 units on a scale Standard Deviation 0.246

SECONDARY outcome

Timeframe: Day 1 post operative

Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.

The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.

Outcome measures

Outcome measures
Measure	27-Gauge n=67 Participants CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	23-Gauge n=67 Participants CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
Mean Post-operative Pain Rating at Day 1	0.9 units on a scale Standard Deviation 1.75	0.6 units on a scale Standard Deviation 1.20

Adverse Events

27-Gauge Treated Eye

Serious events: 15 serious events

Other events: 18 other events

Deaths: 0 deaths

27-Gauge Fellow Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

27-Gauge Systemic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

23-Gauge Treated Eye

Serious events: 16 serious events

Other events: 14 other events

Deaths: 0 deaths

23-Gauge Fellow Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

23-Gauge Systemic

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	27-Gauge Treated Eye n=66 participants at risk Ocular events, treated (study) eye	27-Gauge Fellow Eye n=66 participants at risk Ocular events, untreated (fellow) eye	27-Gauge Systemic n=66 participants at risk Non-ocular adverse events	23-Gauge Treated Eye n=69 participants at risk Ocular events, treated (study) eye	23-Gauge Fellow Eye n=69 participants at risk Ocular events, untreated (fellow) eye	23-Gauge Systemic n=69 participants at risk Non-ocular adverse events
Eye disorders Cataract	10.6% 7/66 • Number of events 7 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	13.0% 9/69 • Number of events 9 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Hypotony of eye	1.5% 1/66 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	2.9% 2/69 • Number of events 2 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Macular fibrosis	1.5% 1/66 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Macular hole	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Retinal detachment	3.0% 2/66 • Number of events 3 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	2.9% 2/69 • Number of events 3 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Retinal tear	1.5% 1/66 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	2.9% 2/69 • Number of events 2 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Retinopathy proliferative	1.5% 1/66 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Visual acuity reduced	9.1% 6/66 • Number of events 6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	10.1% 7/69 • Number of events 7 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Vitreous haemorrhage	1.5% 1/66 • Number of events 2 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Investigations Intraocular pressure decreased	1.5% 1/66 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Nervous system disorders Cerebral haemorrhage	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Surgical and medical procedures Craniotomy	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Surgical and medical procedures Eye laser surgery	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Surgical and medical procedures Eye operation	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 2 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Surgical and medical procedures Retinal laser coagulation	3.0% 2/66 • Number of events 3 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Surgical and medical procedures Retinal operation	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	2.9% 2/69 • Number of events 3 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Surgical and medical procedures Vitrectomy	3.0% 2/66 • Number of events 2 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.

Other adverse events

Other adverse events
Measure	27-Gauge Treated Eye n=66 participants at risk Ocular events, treated (study) eye	27-Gauge Fellow Eye n=66 participants at risk Ocular events, untreated (fellow) eye	27-Gauge Systemic n=66 participants at risk Non-ocular adverse events	23-Gauge Treated Eye n=69 participants at risk Ocular events, treated (study) eye	23-Gauge Fellow Eye n=69 participants at risk Ocular events, untreated (fellow) eye	23-Gauge Systemic n=69 participants at risk Non-ocular adverse events
Eye disorders Conjunctival haemorrhage	13.6% 9/66 • Number of events 9 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	8.7% 6/69 • Number of events 6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Conjunctival oedema	9.1% 6/66 • Number of events 6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	10.1% 7/69 • Number of events 7 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Eye disorders Punctate keratitis	9.1% 6/66 • Number of events 6 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	1.4% 1/69 • Number of events 1 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
Investigations Intraocular pressure increased	9.1% 6/66 • Number of events 7 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/66 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	7.2% 5/69 • Number of events 5 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.	0.00% 0/69 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months). An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.

Additional Information

Brand Lead, Global Medical Affairs

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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