Trials / Completed
CompletedNCT03624699
Investigation of the iStent Inject® Devices in Open-Angle Glaucoma
A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Dr. Kaweh Mansouri · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.
Detailed description
Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Glaukos iStent inject® | iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma |
Timeline
- Start date
- 2018-04-25
- Primary completion
- 2019-12-31
- Completion
- 2020-06-30
- First posted
- 2018-08-10
- Last updated
- 2022-05-05
Locations
1 site across 1 country: Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03624699. Inclusion in this directory is not an endorsement.