Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Summary
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Retinitis Pigmentosa
Intervention
Argus 16 Retinal Stimulation System
Location
Doheny Eye Institute
Los Angeles
California
United States
90033
Status
Active, not recruiting
Source
Second Sight Medical Products
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00279500
- Information obtained from ClinicalTrials.gov on September 06, 2012
Medical and Biotech [MESH] Definitions
Usher Syndromes
Autosomal recessive hereditary disorders characterized by congenital SENSORINEURAL HEARING LOSS and RETINITIS PIGMENTOSA. Genetically and symptomatically heterogeneous, clinical classes include type I, type II, and type III. Their severity, age of onset of retinitis pigmentosa and the degree of vestibular dysfunction are variable.
Cytomegalovirus Retinitis
Infection of the retina by cytomegalovirus characterized by retinal necrosis, hemorrhage, vessel sheathing, and retinal edema. Cytomegalovirus retinitis is a major opportunistic infection in AIDS patients and can cause blindness.
Retinal Necrosis Syndrome, Acute
Mild to fulminant necrotizing vaso-occlusive retinitis associated with a high incidence of retinal detachment and poor vision outcome.
Alstrom Syndrome
Rare autosomal recessive disease characterized by multiple organ dysfunction. The key clinical features include retinal degeneration (NYSTAGMUS, PATHOLOGIC; RETINITIS PIGMENTOSA; and eventual blindness), childhood obesity, sensorineural hearing loss, and normal mental development. Endocrinologic complications include TYPE 2 DIABETES MELLITUS; HYPERINSULINEMIA; ACANTHOSIS NIGRICANS; HYPOTHYROIDISM; and progressive renal and hepatic failures. The disease is caused by mutations in the ALMS1 gene.
Retinitis Pigmentosa
Hereditary, progressive degeneration of the neuroepithelium of the retina characterized by night blindness and progressive contraction of the visual field.
Clinical Trials
Argus™ II Retinal Stimulation System Feasibility Protocol
The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profo...
Safety Study in Retinal Transplantation for Retinitis Pigmentosa.
The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.
Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual functio...
Transcorneal Electrical Stimulation Therapy for Retinal Disease
Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.
Randomized Clinical Trial for Retinitis Pigmentosa
The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.
PubMed Articles
The purpose of this study was to determine the molecular basis of retinitis pigmentosa (RP) in a 4 affected sib-family segregating this retinal phenotype.
A new system for the treatment of retinal degeneration.
Abstract Recent clinical studies indicate that stimulation of the retina with tiny amounts of current can have a therapeutic effect on retinal diseases such as retinitis pigmentosa. We have therefore...
Purpose. Electrical stimulation of retinal neurons has been shown to be a feasible way to elicit visual percepts in patients blind from retinal degenerations. The EPIRET3 retinal implant is the first...
Decreased retinal-choroidal blood flow in retinitis pigmentosa as measured by MRI.
PURPOSE: To evaluate retinal and choroidal blood flow (BF) using high-resolution magnetic resonance imaging (MRI) as well as visual function measured by the electroretinogram (ERG) in patients with re...
PURPOSE:: The purpose of this study was to identify the functional and structural characteristics in three female obligate carriers of X-linked retinitis pigmentosa from the same family by using spect...
