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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080030 / PAS001 |
| Date Original Protocol Accepted |
06/25/2012
|
| Date Current Protocol Accepted |
03/05/2013
|
| Study Name |
Extended F/u of IDE Cohort Study
|
| Device Name |
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Extended follow-up of subjects previously enrolled in Glaukos Study
GC-003; Follow-up through 5 years postoperative
|
| Study Population |
¿ 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:
o Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow- up study
o Patients not previously enrolled in Glaukos Study GC-003
Device subjects received the Glaukos iStent in conjunction with
cataract surgery and controls subjects received cataract surgery alone.
|
| Sample Size |
Of 290 subjects enrolled in Study GC-003, extended follow-up is
planned on subjects eligible to participate in this extended follow-up study.
|
| Key Study Endpoints |
The safety measurement listed in the outline section as:
¿ Postoperative ocular adverse events
¿ Findings from OR medication use, BSCVA, VF
measurements and pachymetry
¿ Findings from slit-lamp, fundus and gonioscopic measurements
|
| Follow-up Visits and Length of Follow-up |
5 years postoperative. 2 years from completion of the IDE study
Annual
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
108
|
| Actual Number of Sites Enrolled |
25
|
| Patient Follow-up Rate |
Only 42.35% (108/255) enrolled at the beginning of the IDE cohort continuation study. Of those 108 subjects enrolled, 100% of subjects were followed through the fifth year post procedure.
|
| Final Safety Findings |
Kaplan-Meier (K-M) analyses for the sight-threatening adverse event rate at 5 years are provided by randomized groups: all eyes with cataract surgery and iStent versus randomized cataract surgery only. The cumulative Kaplan-Meier probability that a patient experienced a sight-threatening adverse event is 26.0% (95% CI 15.6%, 36.3%) in the randomized cataract surgery with stent group (stent group) and 42.8% (95% CI 27.9%, 57.8%) in the cataract surgery only group (control group). These results indicate that the stent group is non-inferior to the control group (p=0.009). Based on the upper 1-sided 90% confidence limit (CL), the stent group has a lower incidence of sight-threatening adverse events than the control group. Analyses presented for the comparison of all eyes with cataract surgery and iStent versus randomized cataract surgery only provide cumulative Kaplan-Meier probability that a patient experienced a sight-threatening adverse event is 28.5.0% (95% CI 19.6%, 37.4%) in the Overall Cataract Surgery with iStent (stent group) and 42.8% (95% CI 27.9%, 57.8%) in the Randomized Cataract Surgery Only (control group). These results indicate that the stent group is non-inferior to the control group (p=0.015). Based on the upper 1-sided 90% confidence limit (CL),the stent group has a lower incidence of sight-threatening adverse events than the control group.
|
| Final Effect Findings |
This study does not include any effectiveness endpoints
|
| Study Strengths & Weaknesses |
Strength: The continued IDE study is an observational study with a clinical trial design with longer term follow-up of safety data.
Weakness: The enrollment rate from the premarket cohort for the eligible subjects is only 42%. The low enrollment rate could introduce bias to the study.
|
| Recommendations for Labeling Changes |
As a result, upon completion of the post approval studies with significant clinical findings, labeling changes is
recommended to update the labeling with long-term device performance results regarding safety
|
