Trial Outcomes & Findings for Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma (NCT NCT02448875)

Last Updated: 2019-06-12

Results Overview

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

192 participants

Primary outcome timeframe

Baseline (Day -1), Month 12 PostOperative

Results posted on

2019-06-12

Participant Flow

Subjects were recruited from 6 study centers located in Germany (3), Poland (1), Spain (1), and Panama (1).

Of the 192 enrolled, 49 subjects were exited prior to randomization. In addition, one randomized subject discontinued prior to treatment. This reporting group includes all treated subjects, Dose Selection Phase and Expansion Phase (142 subjects).

Participant milestones

Participant milestones
Measure	CyPass CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Overall Study STARTED	60	21	61
Overall Study Completed Dose Selection Phase	20	21	20
Overall Study Full Analysis Set	60	21	61
Overall Study Safety Analysis Set	60	21	61
Overall Study COMPLETED	53	20	60
Overall Study NOT COMPLETED	7	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CyPass CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Overall Study Adverse Event	2	1	0
Overall Study Lost to Follow-up	1	0	0
Overall Study Investigator Decision	3	0	1
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Clinical Evaluation of Visco-Assisted CyPass® Micro-Stent Implantation in Patients With Open Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CyPass n=60 Participants CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 n=21 Participants CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 n=61 Participants CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic	Total n=142 Participants Total of all reporting groups
Age, Continuous	65.4 years STANDARD_DEVIATION 9.87 • n=5 Participants	68.7 years STANDARD_DEVIATION 9.68 • n=7 Participants	65.4 years STANDARD_DEVIATION 11.17 • n=5 Participants	65.9 years STANDARD_DEVIATION 10.42 • n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants	65 Participants n=4 Participants
Race/Ethnicity, Customized White	32 Participants n=5 Participants	5 Participants n=7 Participants	36 Participants n=5 Participants	73 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Other	18 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants	52 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1), Month 12 PostOperative

Population: Full Analysis Set with data available

Outcome measures

Outcome measures
Measure	CyPass n=46 Participants CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 n=12 Participants CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 n=49 Participants CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication	63.0 percentage of subjects	83.3 percentage of subjects	73.5 percentage of subjects

SECONDARY outcome

Timeframe: Up to Month 12 PostOperative

Population: Full Analysis Set

A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Outcome measures

Outcome measures
Measure	CyPass n=60 Participants CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 n=21 Participants CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 n=61 Participants CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Percentage of Subjects With Device-related Ocular Adverse Events Intraoperative	1.7 percentage of subjects	4.8 percentage of subjects	4.9 percentage of subjects
Percentage of Subjects With Device-related Ocular Adverse Events Postoperative	58.3 percentage of subjects	71.4 percentage of subjects	63.9 percentage of subjects

SECONDARY outcome

Timeframe: Baseline (Day -1), Month 12 PostOperative

Population: Full Analysis Set with data available

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Outcome measures

Outcome measures
Measure	CyPass n=60 Participants CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 n=21 Participants CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 n=60 Participants CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP Baseline	21.08 millimeters of mercury (mmHg) Standard Deviation 5.004	22.17 millimeters of mercury (mmHg) Standard Deviation 6.683	21.71 millimeters of mercury (mmHg) Standard Deviation 5.279
Mean Change From Baseline to 12 Months Postoperative in Medicated IOP Change from Baseline @ Month 12	-4.29 millimeters of mercury (mmHg) Standard Deviation 5.360	-4.00 millimeters of mercury (mmHg) Standard Deviation 6.736	-4.81 millimeters of mercury (mmHg) Standard Deviation 6.406

SECONDARY outcome

Timeframe: Month 12 PostOperative

Population: Full Analysis Set with data available

The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Outcome measures

Outcome measures
Measure	CyPass n=56 Participants CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 n=21 Eyes CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 n=61 Eyes CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months	37.5 percentage of eyes	42.9 percentage of eyes	36.1 percentage of eyes

SECONDARY outcome

Timeframe: Screening (Day -2), Month 12 PostOperative

Population: Full Analysis Set with data available

The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.

Outcome measures

Outcome measures
Measure	CyPass n=56 Participants CyPass Micro-Stent without adjunct viscoelastic implanted in the study eye	CyPass30 n=21 Participants CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 n=61 Participants CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used	-0.8 IOP-lowering medications Standard Deviation 1.38	-0.3 IOP-lowering medications Standard Deviation 1.74	-0.8 IOP-lowering medications Standard Deviation 1.47

Adverse Events

CyPass Ocular

Serious events: 6 serious events

Other events: 38 other events

Deaths: 0 deaths

CyPass Nonocular

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

CyPass30 Ocular

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

CyPass30 Nonocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CyPass60 Ocular

Serious events: 7 serious events

Other events: 37 other events

Deaths: 0 deaths

CyPass60 Nonocular

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CyPass Ocular n=60 participants at risk Subjects with CyPass Micro-Stent implantation	CyPass Nonocular n=60 participants at risk Subjects with CyPass Micro-Stent implantation	CyPass30 Ocular n=21 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass30 Nonocular n=21 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 Ocular n=61 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic	CyPass60 Nonocular n=61 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Eye disorders Eye disorder	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Eye disorders Hypotony of eye	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Eye disorders Maculopathy	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	4.9% 3/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Eye disorders Narrow anterior chamber angle	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.6% 1/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Infections and infestations Respiratory tract infection	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Injury, poisoning and procedural complications Hyphaema	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.6% 1/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	4.8% 1/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Investigations Intraocular pressure fluctuation	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Investigations Intraocular pressure increased	6.7% 4/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.6% 1/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.6% 1/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Product Issues Device occlusion	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.7% 1/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Surgical and medical procedures Cataract operation	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.6% 1/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Surgical and medical procedures Hospitalisation	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	1.6% 1/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.

Other adverse events

Other adverse events
Measure	CyPass Ocular n=60 participants at risk Subjects with CyPass Micro-Stent implantation	CyPass Nonocular n=60 participants at risk Subjects with CyPass Micro-Stent implantation	CyPass30 Ocular n=21 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass30 Nonocular n=21 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 30 μl ophthalmic viscoelastic	CyPass60 Ocular n=61 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic	CyPass60 Nonocular n=61 participants at risk Subjects with CyPass Micro-Stent implantation followed by targeted delivery of 60 μl ophthalmic viscoelastic
Eye disorders Cataract	21.7% 13/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	14.3% 3/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	23.0% 14/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Eye disorders Visual acuity reduced	33.3% 20/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	33.3% 7/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	31.1% 19/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Investigations Intraocular pressure increased	18.3% 11/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	14.3% 3/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	14.8% 9/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.
Product Issues Device occlusion	20.0% 12/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/60 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	38.1% 8/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/21 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	29.5% 18/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.	0.00% 0/61 • Surgery through study completion, an average of 12 months. Safety was assessed at each study visit. The Safety Analysis Set was used for this analysis.

Additional Information

Senior Clinical Project Lead, CDMA Surgical

Alcon Research

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.
Publication restrictions are in place

Restriction type: OTHER