restoring vision with the intelligent retinal implant system (iris v1)in patients with retinal dystrophy

Conditions: Retinitis Pigmentosa; Cone Rod Dystrophy; Choroideremia

Summary: this study evaluates the safety and effectiveness of the intelligent retinal implants system (iris v1)


Eligibility criteria:
inclusion criteria: * is 25 years or older at the date of enrolment * has a confirmed diagnosis of retinitis pigmentosa, choroideremia or cone-rod dystrophy * has a visual acuity of logmar 2.3 or worse in both the eyes as determined by a square grating scale. * has functional ganglion cells and optic nerve activity * has a memory of former useful form vision * understands and accepts the obligation to present for all schedule follow-up visits. * has ap eye dimensions that are appropriate with the dimensions of the implant(in germany: has an ap eye dimension between 20.5 and 25 mm) * has head dimensions that are appropriate for visual interface. exclusion criteria: * has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex, * has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, current or prior retinal detachment, infectious or inflammatory retinal disease, etc.), * has any disease or condition that prevents adequate visualization of the retina of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation, * has any disease or condition of the anterior segment of the study eye that prevents adequate physical examination (e.g., ocular trauma, etc.), * has severe nystagmus, * has any ocular condition that leads him or her to eye rubbing, * has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness , multiple sclerosis, amyotrophc lateral sclerosis, neuritis, etc), * has a history of epileptic seizure, * has a history of chronic or recurrent infection or inflammation that would preclude participation in the study, * has a known sensitivity to the contact materials of the implant, * presents with hypotony in the study eye, * presents with hypertony in the study eye, * is pregnant or lactating, * has another active implanted device (e.g. cochlear implant) or any form of metallic implant in the head (other than dental work) that may interfere with the device function, * has a diagnosis requiring an active implant (e.g., cardiac pacemaker, vagus nerve implant, etc.), * has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis, * is an immune-suppressed subject (e.g., due to hiv positive diagnosis, etc.), * is carrier of multi-resistant germs, * requires the use of any of the following medications: * antimetabolites, * thrombocyte aggregation reducing therapies (10 days prior until 3 days after surgery), * oral anticoagulants (5 days before until 3 days after surgery), * is participating in another investigational drug or device study that may interfere with the proposed treatment or the ensuring follow-up schedule, (in germany: is participating in another investigational drug or device study) * has any health concern that makes general anaesthesia inadvisable, (in germany: patients with an asa-score of 3 or higher are excluded from the study) * is likely requiring mri scans subsequent to implantation and prior to explantation, * is likely requiring therapeutic ultrasound subsequent to implantation and prior to explantation of the retinal implant in germany: - patients with recurrent or chronic inflammations or infections are excluded from the study. specifically patients with the following disorders are excluded: * common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. crohn disease, whipple's disease) * chronic inflammation of the skin in the area of the eye (e.g. dermatitis, rosacea, infection of the skin, herpes zoster) * chronic inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, horedolum, chalazion) in germany: - has a severe psychological disorder. when in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial. in germany: - has severe renal, cardiac, hepatic etc. organ diseases