Retinal Degeneration, Retinitis Pigmentosa
Conditions
Keywords
Hereditary retinal, degeneration outer, retinal layers, photoreceptor rods cones, Retinitis pigmentosa, blindness, reading ability, retina implant, subretinal
Brief summary
Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
Interventions
PROCEDUREsurgical implantation of subretinal device
surgical implantation of subretinal device
Sponsors
Retina Implant AG
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones. * Pseudophakia * Angiography shows retinal vessels adequately perfused, despite pathological RP condition. * Age between 18 and 78 years. * Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation (impaired light localization or worse). * Ability to read normal print in earlier life, optically corrected without magnifying glass. * Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year
Exclusion criteria
* Period of appropriate visual functions \< 12 years / lifetime. * Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant. * Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT). * Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP). * Heavy clumped pigmentation at posterior pole * Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment). * Amblyopia reported earlier in life on eye to be implanted * Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases). * Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression). * Hyperthyroidism or hypersensitivity to iodine * Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study. * Participation in another interventional clinical trial within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 year | treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients |
| Efficacy | 1 year | Activities of Daily Living & Mobility are significantly improved with implant-ON versus OFF, as shown via tests: * Activities of Daily Living tasks or * Recognition tasks or * Mobility or * a combination of the above |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 year | Patient long term safety: * stability of implant function * stability of body structure & function related to implant system |
| Efficacy | 1 year | Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via: * FrACT or * BaLM or * Grating test (e.g. BaGA) and/or Quality of life * Quality of life (questionnaire) or * a combination of the above |
Countries
Hong Kong
Outcome results
None listed