Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01052558 | GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma | PHASE3 | COMPLETED | 164 | — | — | Jan 1, 2010 | Dec 1, 2013 | May 19, 2015 | 22 | United States |
| Arm | Type | Description |
|---|---|---|
| Cataract Surgery Only | ACTIVE_COMPARATOR | - |
| Treatment with Cataract Surgery & Stents | EXPERIMENTAL | Ab interno trabecular micro-bypass stent surgery |
| Name | Type | Description |
|---|---|---|
| iStent Inject (GTS400) | DEVICE | Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents. |
| Cataract Surgery | PROCEDURE | Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only. |
Inclusion Criteria: * Diagnosed with open-angle glaucoma in the study eye * Subject must be on 1 to 3 glaucoma medications * Subject able and willing to attend follow up visits for two years postop * Subject able and willing to sign informed consent Exclusion Criteria: * Pseudoexfoliative and pig...