Trial Outcomes & Findings for Next Generation Cataract and Vitreoretinal Surgery Study (NCT NCT06165744)

NCT ID: NCT06165744

Last Updated: 2025-06-25

Results Overview

As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2025-06-25

Participant Flow

Participants were recruited from 5 investigative sites located in Australia.

Of the 120 participants enrolled in the study, 2 were exited as screen failures, resulting in 118 participants treated. This reporting group includes all treated participants.

Unit of analysis: eyes

Participant milestones

Measure	UNITY VCS Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Overall Study STARTED	118 118
Overall Study COMPLETED	117 117
Overall Study NOT COMPLETED	1 1

Reasons for withdrawal

Measure	UNITY VCS Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Overall Study Non device-related adverse event	1

Baseline Characteristics

Next Generation Cataract and Vitreoretinal Surgery Study

Baseline characteristics by cohort

Measure	UNITY VCS n=118 Participants Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Age, Continuous	66.5 years STANDARD_DEVIATION 13.44 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized White	91 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	16 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants
Region of Enrollment Australia	118 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Population: Full Analysis Set

As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Outcome measures

Measure	UNITY VCS n=117 eyes Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"	100 percentage of responses Interval 96.9 to 100.0

SECONDARY outcome

Timeframe: Day 0 operative, up to surgery completion

Population: Full Analysis Set

The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Outcome measures

Measure	UNITY VCS n=117 eyes Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Mean Total Time in Eye	22.788 minutes Standard Deviation 11.5663

SECONDARY outcome

Timeframe: Month 3 Postoperative

Population: Full Analysis Set with data at Month 3 visit

As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Outcome measures

Measure	UNITY VCS n=116 eye Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"	96.6 percentage of responses Interval 91.4 to 99.1

SECONDARY outcome

Timeframe: Preoperative (Day -30 to 0), Month 3 Postoperative

Population: Full Analysis Set with numerical Snellen values at both Preoperative and Month 3 visits

Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Outcome measures

Measure	UNITY VCS n=99 eyes Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS
Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3	0.186 decimal Standard Deviation 0.2410

Adverse Events

Pretreatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

UNITY VCS Ocular - Study Eye

Serious events: 38 serious events

Other events: 21 other events

Deaths: 0 deaths

UNITY VCS Systemic

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pretreatment n=118 participants at risk AEs in this group occurred prior to treatment with UNITY VCS	UNITY VCS Ocular - Study Eye n=118 participants at risk AEs in this group occurred after attempted treatment with with UNITY VCS and include ocular events in the study eye. "At Risk" population is reported in units of eyes.	UNITY VCS Systemic n=118 participants at risk AEs in this group occurred after attempted treatment with UNITY VCS and include overall systemic events as well as ocular events in the non-study eye. "At Risk" population is reported in units of subjects.
Eye disorders Cystoid macular oedema	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	2.5% 3/118 • Number of events 3 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Diabetic retinal oedema	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	1.7% 2/118 • Number of events 2 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Epiretinal membrane	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Hypotony of eye	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Iris disorder	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Macular hole	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	1.7% 2/118 • Number of events 2 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Macular oedema	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Pupillary block	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Retinal detachment	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	6.8% 8/118 • Number of events 10 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Retinal disorder	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	1.7% 2/118 • Number of events 2 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Retinal haemorrhage	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	1.7% 2/118 • Number of events 2 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Retinal oedema	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Retinal tear	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	9.3% 11/118 • Number of events 11 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Eye disorders Vitreous haemorrhage	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	6.8% 8/118 • Number of events 8 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Infections and infestations COVID-19	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Investigations Intraocular pressure increased	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	4.2% 5/118 • Number of events 5 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Nervous system disorders Cerebrovascular accident	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 2 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Surgical and medical procedures Intra-ocular injection	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	5.1% 6/118 • Number of events 9 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Surgical and medical procedures Iridotomy	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 2 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Surgical and medical procedures Retinal operation	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	7.6% 9/118 • Number of events 10 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.

Other adverse events

Measure	Pretreatment n=118 participants at risk AEs in this group occurred prior to treatment with UNITY VCS	UNITY VCS Ocular - Study Eye n=118 participants at risk AEs in this group occurred after attempted treatment with with UNITY VCS and include ocular events in the study eye. "At Risk" population is reported in units of eyes.	UNITY VCS Systemic n=118 participants at risk AEs in this group occurred after attempted treatment with UNITY VCS and include overall systemic events as well as ocular events in the non-study eye. "At Risk" population is reported in units of subjects.
Eye disorders Cataract	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	5.9% 7/118 • Number of events 7 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.
Investigations Intraocular pressure increased	0.00% 0/118 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	12.7% 15/118 • Number of events 15 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.	0.85% 1/118 • Number of events 1 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. This analysis population includes all subjects/eyes with attempted use of the UNITY VCS (successful or aborted after contact with the eye). The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting groups.

Additional Information

Sr. Principal Clinical Project Lead, Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

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.
• Publication restrictions are in place

Restriction type: OTHER