Trial Outcomes & Findings for Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort (NCT NCT01836042)

Results Overview

The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.

Recruitment status

COMPLETED

Target enrollment

108 participants

Primary outcome timeframe

80 Month average

Results posted on

2016-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized iStent Implantation of one iStent in conjunction with cataract surgery, patients randomized to group	Randomized Cataract Surgery Cataract surgery alone, patients randomized to group	Non-randomized iStent Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
Overall Study STARTED	51	35	22
Overall Study COMPLETED	51	35	22
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized iStent n=51 Participants Implantation of one iStent in conjunction with cataract surgery, patients randomized to group	Randomized Cataract Surgery n=35 Participants Cataract surgery alone, patients randomized to group	Non-randomized iStent n=22 Participants Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group	Total n=108 Participants Total of all reporting groups
Age, Continuous	72 years STANDARD_DEVIATION 7.7 • n=93 Participants	69 years STANDARD_DEVIATION 8.4 • n=4 Participants	71 years STANDARD_DEVIATION 8.6 • n=27 Participants	71 years STANDARD_DEVIATION 8.1 • n=483 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	22 Participants n=4 Participants	10 Participants n=27 Participants	57 Participants n=483 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	13 Participants n=4 Participants	12 Participants n=27 Participants	51 Participants n=483 Participants
Region of Enrollment United States	51 participants n=93 Participants	35 participants n=4 Participants	22 participants n=27 Participants	108 participants n=483 Participants

PRIMARY outcome

Timeframe: 80 Month average

The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.

Outcome measures

Outcome measures
Measure	Randomized iStent n=51 Participants Implantation of one iStent in conjunction with cataract surgery, patients randomized to group	Randomized Cataract Surgery n=35 Participants Cataract surgery alone, patients randomized to group	Non-randomized iStent n=22 Participants Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
Rate of Sight-threatening Adverse Events	27.8 percentage of subjects	45.7 percentage of subjects	34.3 percentage of subjects

Adverse Events

Randomized iStent

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Randomized Cataract Surgery

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Non-randomized iStent

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Randomized iStent n=111 participants at risk Implantation of one iStent in conjunction with cataract surgery, patients randomized to group	Randomized Cataract Surgery n=122 participants at risk Cataract surgery alone, patients randomized to group	Non-randomized iStent n=46 participants at risk Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
Eye disorders Age-related macular degeneration or worsening of AMD	6.3% 7/111 • Number of events 8	4.9% 6/122 • Number of events 6	2.2% 1/46 • Number of events 1
Eye disorders Epiretinal membrane	3.6% 4/111 • Number of events 4	1.6% 2/122 • Number of events 4	10.9% 5/46 • Number of events 5
Eye disorders Loss of BCVA greater or equal to 3 lines	1.8% 2/111 • Number of events 2	5.7% 7/122 • Number of events 7	0.00% 0/46

Additional Information

Jeff Wells, PharmD, MBA, RAC

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