Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients.

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.

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.