Primary Open Angle Glaucoma
Conditions
Keywords
Primary open-angle glaucoma (POAG), Trabecular meshwork, iStent
Brief summary
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.
Detailed description
The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.
Interventions
None listed
Sponsors
Glaukos Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study
Exclusion criteria
* Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study * Patients not previously enrolled in Glaukos Study GC-003
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Sight-threatening Adverse Events | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized iStent Implantation of one iStent in conjunction with cataract surgery, patients randomized to group | 51 |
| Randomized Cataract Surgery Cataract surgery alone, patients randomized to group | 35 |
| Non-randomized iStent Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group | 22 |
| Total | 108 |
Baseline characteristics
| Characteristic | Randomized iStent | Randomized Cataract Surgery | Non-randomized iStent | Total |
|---|---|---|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 7.7 | 69 years STANDARD_DEVIATION 8.4 | 71 years STANDARD_DEVIATION 8.6 | 71 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 51 participants | 35 participants | 22 participants | 108 participants |
| Sex: Female, Male Female | 25 Participants | 22 Participants | 10 Participants | 57 Participants |
| Sex: Female, Male Male | 26 Participants | 13 Participants | 12 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 111 | 15 / 122 | 6 / 46 |
| serious Total, serious adverse events | 0 / 111 | 0 / 122 | 0 / 46 |
Outcome results
Primary
Rate of Sight-threatening Adverse Events
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.
Time frame: 80 Month average
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized iStent | Rate of Sight-threatening Adverse Events | 27.8 percentage of subjects |
| Randomized Cataract Surgery | Rate of Sight-threatening Adverse Events | 45.7 percentage of subjects |
| Non-randomized iStent | Rate of Sight-threatening Adverse Events | 34.3 percentage of subjects |