Trial Outcomes & Findings for InnFocus MicroShunt Versus Trabeculectomy Study (NCT NCT01881425)

Last Updated: 2022-10-26

Results Overview

The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up

Recruitment status

COMPLETED

Study phase

Target enrollment

732 participants

Primary outcome timeframe

12 months

Results posted on

2022-10-26

Participant Flow

This report presents data for 527 out of 732 patients who were enrolled in the INN-005 study and who were either randomized to the MicroShunt or Trabeculectomy.

Participant milestones

Participant milestones
Measure	InnFocus MicroShunt The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy The control group consists of subjects who receive trabeculectomy with MMC
Overall Study STARTED	395	132
Overall Study COMPLETED	370	123
Overall Study NOT COMPLETED	25	9

Reasons for withdrawal

Reasons for withdrawal
Measure	InnFocus MicroShunt The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy The control group consists of subjects who receive trabeculectomy with MMC
Overall Study Death	5	1
Overall Study Withdrawal by Subject	8	3
Overall Study Physician Decision	2	1
Overall Study Adverse Event	3	0
Overall Study General Anesthesia panic attack	0	1
Overall Study Subject randomized after study treatment cut off	0	1
Overall Study Lost to Follow-up	7	2

Baseline Characteristics

InnFocus MicroShunt Versus Trabeculectomy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InnFocus MicroShunt n=395 Participants InnFocus MicroShunt InnFocus MicroShunt: An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure.	Trabeculectomy n=132 Participants glaucoma surgery to reduce IOP Glaucoma Surgery: An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a "fornix-based" conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure.	Total n=527 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	164 Participants n=99 Participants	51 Participants n=107 Participants	215 Participants n=206 Participants
Age, Categorical >=65 years	231 Participants n=99 Participants	81 Participants n=107 Participants	312 Participants n=206 Participants
Sex: Female, Male Female	214 Participants n=99 Participants	59 Participants n=107 Participants	273 Participants n=206 Participants
Sex: Female, Male Male	181 Participants n=99 Participants	73 Participants n=107 Participants	254 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	10 Participants n=99 Participants	6 Participants n=107 Participants	16 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	71 Participants n=99 Participants	11 Participants n=107 Participants	82 Participants n=206 Participants
Race (NIH/OMB) White	311 Participants n=99 Participants	113 Participants n=107 Participants	424 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Netherlands	13 Participants n=99 Participants	5 Participants n=107 Participants	18 Participants n=206 Participants
Region of Enrollment United States	337 Participants n=99 Participants	113 Participants n=107 Participants	450 Participants n=206 Participants
Region of Enrollment Italy	10 Participants n=99 Participants	3 Participants n=107 Participants	13 Participants n=206 Participants
Region of Enrollment United Kingdom	10 Participants n=99 Participants	5 Participants n=107 Participants	15 Participants n=206 Participants
Region of Enrollment France	12 Participants n=99 Participants	2 Participants n=107 Participants	14 Participants n=206 Participants
Region of Enrollment Spain	13 Participants n=99 Participants	4 Participants n=107 Participants	17 Participants n=206 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Primary Effectiveness Endpoint at 12 Months

The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up

Outcome measures

Outcome measures
Measure	InnFocus MicroShunt n=395 Participants The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=132 Participants The control group consists of subjects who receive trabeculectomy with MMC
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure	216 Participants	96 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Primary Effectiveness Endpoint at 24 Months

The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up

Outcome measures

Outcome measures
Measure	InnFocus MicroShunt n=395 Participants The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=132 Participants The control group consists of subjects who receive trabeculectomy with MMC
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure	200 Participants	85 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-treat (ITT) Population consisted of 527 randomized subjects and was population for Primary Effectiveness Endpoint/Secondary Effectiveness Endpoint #2. 395 in MicroShunt group and 132 in Trab. Secondary Effectiveness Endpoint #1 based on Glaucoma Reoperation Censored Subpopulation ITT Population which is why numbers differ. Glaucoma Reoperation Censored Subpopulation (subject data excluded from date of a qualifying glaucoma reoperation).

Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 12 months.

Outcome measures

Outcome measures
Measure	InnFocus MicroShunt n=332 Participants The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=114 Participants The control group consists of subjects who receive trabeculectomy with MMC
Mean Diurnal Intraocular Pressure Change	-6.46 mmHg Standard Deviation 5.56	-9.80 mmHg Standard Deviation 5.92

SECONDARY outcome

Timeframe: 24 months

Secondary Effectiveness Endpoint #1 is the mean diurnal change in IOP from Screening at 24 months

Outcome measures

Outcome measures
Measure	InnFocus MicroShunt n=301 Participants The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=110 Participants The control group consists of subjects who receive trabeculectomy with MMC
Mean Diurnal Intraocular Pressure Change	-6.55 mmHg Standard Deviation 5.47	-9.85 mmHg Standard Deviation 5.48

SECONDARY outcome

Timeframe: 12 months

Population: To show Postoperative Interventions at 12 Months

The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 12 follow-up visit.

Outcome measures

Outcome measures
Measure	InnFocus MicroShunt n=395 Participants The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=132 Participants The control group consists of subjects who receive trabeculectomy with MMC
Number of Participants With Postoperative Interventions at 12 Months	161 Participants	89 Participants

SECONDARY outcome

Timeframe: 24 months

Population: To show Postoperative Interventions at 24 Months

The Secondary Effectiveness Endpoint #2 was having any physical or medical postoperative intervention (other than eye massage) intended to alter IOP by the Month 24 follow-up visit.

Outcome measures

Outcome measures
Measure	InnFocus MicroShunt n=395 Participants The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=132 Participants The control group consists of subjects who receive trabeculectomy with MMC
Participants With Postoperative Interventions at 24 Months	219 Participants	93 Participants

Adverse Events

InnFocus MicroShunt

Serious events: 13 serious events

Other events: 366 other events

Deaths: 5 deaths

Trabeculectomy

Serious events: 3 serious events

Other events: 122 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	InnFocus MicroShunt n=395 participants at risk The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=131 participants at risk The control group consists of subjects who receive trabeculectomy with MMC
Eye disorders Increased IOP Requiring Treatment	1.8% 7/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Retinal Complication (Dialysis, Flap Tears, Detachment, Decompression or Proliferative Retinopathy)	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	1.5% 2/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Aqueous Humor Misdirection (malignant glaucoma)	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Choroidal Effusion / Detachment	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Hypotony (IOP < 6mmHg at any Time)	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Subconjunctival Bleeding or Hyphema at any time (including Microhyphema)	0.00% 0/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.76% 1/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Glaucoma Progression with Vision Loss	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Confirmed Worsening in the Visual Field	0.25% 1/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	0.00% 0/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.

Other adverse events

Additional Information

Sharon Herbert, Director of Global Clinical Operations

InnFocus, Inc. (a Santen Company)

Phone: (415) 268-9059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	InnFocus MicroShunt n=395 participants at risk The treatment group consists of subjects who receive the InnFocus MicroShunt with Mitomycin C (MMC).	Trabeculectomy n=131 participants at risk The control group consists of subjects who receive trabeculectomy with MMC
Eye disorders Increased IOP Requiring Treatment	54.4% 215/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	55.7% 73/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Hypotony (IOP < 6mmHg at any Time)	30.6% 121/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	51.1% 67/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Subconjunctival Bleeding or Hyphema at any time including Microhyphema	21.0% 83/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	17.6% 23/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Confirmed Worsening in the Visual Field Mean Deviation	18.5% 73/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	20.6% 27/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Cataract Progression	14.2% 56/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	21.4% 28/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Loss 2 or More Lines of BCVA	13.9% 55/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	17.6% 23/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Bleb Leak / Bleb Leak Based on Positive Seidel Test	9.1% 36/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	14.5% 19/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Corneal Edema	8.9% 35/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	6.1% 8/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Anterior Chamber Cells and/or Flare	7.8% 31/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	8.4% 11/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Dry Eye	7.1% 28/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	9.2% 12/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Pain	6.6% 26/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	9.9% 13/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Blurry Vision	8.4% 33/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	6.9% 9/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Shallow Anterior Chamber	6.8% 27/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	8.4% 11/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Foreign Body Sensation	7.6% 30/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	7.6% 10/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Ptosis	8.4% 33/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	5.3% 7/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Bleb Related Complications	7.1% 28/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	6.9% 9/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Choroidal Effusion / Detachment	4.6% 18/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	7.6% 10/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Diplopia	6.6% 26/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	5.3% 7/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Conjunctival Injection / Conjunctival Hyperemia / Conjunctival Inflammation / Conjunctival Scarring	5.8% 23/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	4.6% 6/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Encapsulated Bleb	5.8% 23/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	2.3% 3/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Eye disorders Ocular Irritation	4.6% 18/395 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.	6.9% 9/131 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for the duration of the study (24 Months). This analysis population includes all subjects who were treated. Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.