Trials / Completed
CompletedNCT02670980
Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Science Corporation · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intelligent Retinal Implant System |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2019-05-01
- Completion
- 2019-05-01
- First posted
- 2016-02-02
- Last updated
- 2019-05-29
Locations
9 sites across 5 countries: Austria, France, Germany, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02670980. Inclusion in this directory is not an endorsement.