Clinical Trials Directory

Trials / Completed

CompletedNCT01024803

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Retina Implant AG · Industry
Sex
All
Age
18 Years – 78 Years
Healthy volunteers
Not accepted

Summary

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight. Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.

Conditions

Interventions

TypeNameDescription
DEVICEDevice name: "Retina Implant model Alpha". Surgical implantation of medical device into eyeSurgical implantation of medical device named "Retina Implant" into eye to restore vision partially. Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.

Timeline

Start date
2009-12-01
Primary completion
2017-04-01
Completion
2018-04-01
First posted
2009-12-03
Last updated
2018-09-05

Locations

6 sites across 3 countries: Germany, Hungary, United Kingdom

Source: ClinicalTrials.gov record NCT01024803. Inclusion in this directory is not an endorsement.