retinitis pigmentosa
Conditions
Interventions
Implantation of retinal prosthesis
Sponsors
Department of Applied Visual Science, Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are diagnosed retinitis pigmentosa by multiple ophthalmologists. 2. Patients whose visual acuity are hand motion, light perception, or no light perception. 3. Patients who do not have any severe disease except from eye diseases. 4. Patients who are able to live independent daily life and walk using a white cane. 5. Patients who can go to the hospital for regular examinations after the surgery. 6. Patient's family members are able to take care of their daily living. 7. The age limits are from 40 to 75 years old. 8. Written informed consent is obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Patients with glaucoma, optic nerve disease, or retinal disease except from retinitis pigmentosa. 2. Patients with intracranial disease such as cerebral infarction or brain tumor. 3. Patients who are implanted any electrical device such as a cochlear implant or a deep brain stimulation. 4. Patients who are pregnant. 5. Patients with epilepsy. 6. Patients who cannot find phosphenes by electrical stimulation through cornea with less than 1.5 mA 7. Patients who refuse to receive treatment. 8. Patients who are decided by physicians in charge as being inappropriate this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy; comparison of the results of localization test, motion test, grating acuity, and mobility test. Safety; slit lamp examination, funduscopy and device check | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy; mobility test, questionnaire for quality of vision, PET, and NIRS Safety; fluorescein angiography, eye-movement test, OCT,and phosphene test in transcorneal-stimulation | — |
Countries
Japan
Contacts
Public ContactTakashi Fujikado
Osaka University Graduate School of Medicine Department of Applied Visual Science
Outcome results
None listed