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Sponsored by: |
Retina Implant AG |
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Information provided by: | Retina Implant AG |
ClinicalTrials.gov Identifier: | NCT00515814 |
The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.
Condition | Intervention |
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Retinitis Pigmentosa |
Device: Retina implant is surgically placed into subretinal position |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Open Pilot Study With Functional Placebo-Control to Evaluate the Efficacy and Tolerability/Safety of a Subretinal Implant in Blind Patients in Accordance With ICH/GCP Guidelines |
Estimated Enrollment: | 15 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1, 2: Experimental
During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.
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Device: Retina implant is surgically placed into subretinal position
Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.
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Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.
Ages Eligible for Study: | 18 Years to 78 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara - Wilhelm, PD Dr.med. | 49-7071-298-4898 | barbara.wilhelm@stz-biomed.de |
Contact: Anuschirawan - Hekmat, Dr.rer.nat. | 49-7121-3640-3251 | hekmat@retina-implant.de |
Germany | |
University Eye Hospital Tuebingen | Recruiting |
Tuebingen, Germany, 72076 | |
Principal Investigator: Karl-Ulrich - Bartz-Schmidt, Prof.Dr.med. | |
Sub-Investigator: Helmut - Sachs, PD Dr. med. | |
Eye Hospital Dresden-Friedrichstadt | Recruiting |
Dresden, Germany, 01067 | |
Principal Investigator: Helmut - Sachs, PD Dr.med. |
Principal Investigator: | Eberhart - Zrenner, Prof.Dr.med. | University Eye Hospital Tuebingen, Germany |
Responsible Party: | Centre for Ophthalmology, Institute for Ophthalmic Research, University of Tuebingen ( Eberhart Zrenner / Prof. MD ) |
Study ID Numbers: | RI-PT-2005, Retina Implant Project |
Study First Received: | August 13, 2007 |
Last Updated: | June 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00515814 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Legal blindness Retinopathia Retinitis pigmentosa Hereditary condition |
Photo-receptor degeneration Retina implant Subretinal |
Pigmentary Retinopathy Cone Rod Dystrophy Genetic Diseases, Inborn Eye Diseases Retinitis Pigmentosa |
Retinitis Retinal Degeneration Eye Diseases, Hereditary Blindness Retinal Diseases |
Genetic Diseases, Inborn Eye Diseases Retinitis Pigmentosa Retinitis |
Retinal Degeneration Eye Diseases, Hereditary Retinal Diseases |