Retinitis Pigmentosa
Conditions
Keywords
Legal blindness, Retinopathy pigmentosa, Hereditary condition, Photo-receptor degeneration, Retina implant, Subretinal implant
Brief summary
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.
Detailed description
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.
Interventions
DEVICERetina 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.
Sponsors
Retina Implant AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density * Blindness (at least monocular) or visual functions not appropriate for navigation/orientation * Period of appropriate visual functions \> 12 years / lifetime * Visual acuity ≥ 0,05 in earlier life * Electrically Evoked Phosphenes provide evidence of inner-retinal function. * willing and able to give written informed consent
Exclusion criteria
* Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment) * Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases) * Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression ) * Retina detected as too thin (\< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT). * 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 clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity / Light-perception / Object-orientation are significantly improved with implant-ON versus OFF as shown via FrACT / BaLM / grating test (i.e. EFFICACY) | within implantation period |
| Patient treatment shows acceptable results (i.e. SAFETY) | within implantation period |
Secondary
| Measure | Time frame |
|---|---|
| Activities of Daily Living are significantly improved with implant-ON versus OFF, as shown via Tasks of Daily Living test / Orientation & Mobility test (i.e. EFFICACY) | within implantation period |
| Non-acceptable surgical complications will terminate clinical study (i.e. SAFETY) | within implantation period |
Countries
Germany
Outcome results
None listed