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

NCT01024803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-09-05

No results posted yet for this study

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

DEVICE

Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye

Surgical 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.

Sponsors & Collaborators

  • Retina Implant AG

    lead INDUSTRY

Principal Investigators

  • Eberhart Zrenner, Prof. MD · Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen, Germany

  • Karl-Ulrich Bartz-Schmidt, Prof. MD · University Eye Hospital Tuebingen, Germany

  • Timothy L Jackson, PhD FRCOphth · King's College Hospital NHS Trust

  • János Németh, Prof. MD PhD · Department of Ophthalmology Semmelweis University Budapest

  • Robert E MacLaren, Prof. DPhil · Department of Ophthalmology, John Radcliffe Hospital, Oxford, UK

  • Johann Roider, Prof. MD · University Eye Hospital, Kiel, Germany

  • Helmut Sachs, PD, MD · Eye Hospital Dresden-Friedrichstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2017-04-30
Completion
2018-04-30

Countries

  • Germany
  • Hungary
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024803 on ClinicalTrials.gov