Trial Outcomes & Findings for A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma (NCT NCT00323284)

Results Overview

Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

12 months

Results posted on

2018-01-12

Participant Flow

The study recruited subjects between April 2005 and February 2008. The main part of the study consisted of a randomized portion where subjects were randomized 1:1 to either iStent plus Cataract Surgery, or Cataract Surgery only. Following the randomized portion, addtional subjects were enrolled in a non-randomized portion.

Following screening, eligible subjects underwent a wash out of topical hypotensive medication prior to the baseline exam.

Participant milestones

Participant milestones
Measure	A--iStent Plus Cataract Surgery iStent plus Cataract Surgery	B--Cataract Surgery Only Cataract Surgery only
12 Months Follow-up STARTED	116	123
12 Months Follow-up COMPLETED	111	114
12 Months Follow-up NOT COMPLETED	5	9
24 Months Follow-up STARTED	116	123
24 Months Follow-up COMPLETED	98	101
24 Months Follow-up NOT COMPLETED	18	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A--iStent Plus Cataract Surgery n=116 Participants iStent plus Cataract Surgery	B--Cataract Surgery Only n=123 Participants Cataract Surgery only	Total n=239 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants
Age, Categorical >=65 years	97 Participants n=93 Participants	104 Participants n=4 Participants	201 Participants n=27 Participants
Age, Continuous	73.96 years STANDARD_DEVIATION 7.66 • n=93 Participants	72.88 years STANDARD_DEVIATION 8.66 • n=4 Participants	73.42 years STANDARD_DEVIATION 8.11 • n=27 Participants
Sex: Female, Male Female	70 Participants n=93 Participants	71 Participants n=4 Participants	141 Participants n=27 Participants
Sex: Female, Male Male	46 Participants n=93 Participants	52 Participants n=4 Participants	98 Participants n=27 Participants
Region of Enrollment United States	116 participants n=93 Participants	123 participants n=4 Participants	239 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intent to treat analysis of all enrolled subjects using non-responder approach

Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months

Outcome measures

Outcome measures
Measure	A--iStent Plus Cataract Surgery n=116 Participants iStent plus Cataract Surgery	B--Cataract Surgery Only n=123 Participants Cataract Surgery only
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds	68 percent of subjects achieving endpoint Interval 60.0 to 77.0	50 percent of subjects achieving endpoint Interval 41.0 to 58.0

SECONDARY outcome

Timeframe: 12 months

Population: Intent to treat population using non-responder approach

Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months

Outcome measures

Outcome measures
Measure	A--iStent Plus Cataract Surgery n=116 Participants iStent plus Cataract Surgery	B--Cataract Surgery Only n=123 Participants Cataract Surgery only
Efficacy	64 percent Interval 55.0 to 73.0	47 percent Interval 38.0 to 56.0

Adverse Events

A--iStent Plus Cataract Surgery

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

B--Cataract Surgery Only

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A--iStent Plus Cataract Surgery n=116 participants at risk iStent plus Cataract Surgery	B--Cataract Surgery Only n=123 participants at risk Cataract Surgery only
Eye disorders Best Corrected Visual Acuity loss greater than 1 line at or after the 3 month visit	0.86% 1/116 • Number of events 1 • Two years	0.81% 1/123 • Number of events 1 • Two years

Other adverse events

Other adverse events
Measure	A--iStent Plus Cataract Surgery n=116 participants at risk iStent plus Cataract Surgery	B--Cataract Surgery Only n=123 participants at risk Cataract Surgery only
Eye disorders Early post-op corneal edema	7.8% 9/116 • Number of events 9 • Two years	8.9% 11/123 • Number of events 11 • Two years
Eye disorders Posterior capsular opacification	6.0% 7/116 • Number of events 7 • Two years	9.8% 12/123 • Number of events 12 • Two years
Eye disorders Any BCVA loss greater than 1 line of vision at or after the 3 month visit	6.0% 7/116 • Number of events 7 • Two years	8.9% 11/123 • Number of events 11 • Two years
Eye disorders Blurry vision or visual disturbance	3.4% 4/116 • Number of events 4 • Two years	6.5% 8/123 • Number of events 8 • Two years

Additional Information

Jeff Wells, Sr. VP, Clinical, Regulatory, and Quality Affairs

Glaukos

Phone: 949-367-9600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60