Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration

Ki vehet részt

• Is 18 years or older at the date of inclusion
• Has a confirmed diagnosis of inherited retinal degeneration with the macula affected in both eyes
• The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test
• Has an atrophic patch in the study eye including the fovea of at least the implant size (>4.5 mm2 and >2.4 mm in minimum diameter)
• Understands the constraints of the study and accepts to present for all scheduled follow-up visits
• Signed the informed consent

Ki nem vehet részt

• 1. Has cataract in the study eye (with LOCS III scale NO, NC, C or P>1); (these patients will need to have cataract surgery performed prior to completion of baseline testing; all other patients will get IOL replacement during the PRIMA Stim implantation)
• Underwent intraocular lens implantation in the study eye within the last month prior to enrolment (this corresponds to 4 weeks or 28 days)
• Has any disease or condition that prevents adequate examination (including Optical Coherence Tomography (OCT)) of the study eye including but not limited to media opacities that cannot be resolved prior to implantation. Note, that this criterion is also important for the function of the implant
• Has a known sensitivity to the contact materials of the implant (iridium oxide, silicon-carbide and titanium)
• Is receiving anticoagulation therapy that cannot be adapted to allow eye surgery
• Is participating in another investigational drug or device study that may interfere with the PRIMAlia study
• Has too high and/or unrealistic expectations (e.g., believes that a benefit is guaranteed or expects normal vision after surgery)
• Has a history of documented choroidal neovascularization in either eye
• Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye or the visual system (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, Proliferative Diabetic Retinopathy (PDR), diabetic macular oedema (DME), severe Non-Proliferative Diabetic Retinopathy (NPDR), retinal detachment, infectious or inflammatory retinal disease, severe glaucoma, optic neuropathy, etc.)
• Suffers from nystagmus or other ocular motility disorders
• Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness, severe multiple sclerosis, amyotrophic lateral sclerosis, severe neuritis, etc.)
• Has uncontrolled epileptic seizures
• Has a known allergy to anaesthetic drugs
• Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis
• Is an immune-suppressed participant (e.g., due to HIV positive diagnosis, etc.)
• Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study
• Has significant recurrent or chronic inflammations or infections. Specifically, patients with the following disorders are excluded:; Severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease); Active inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion)
• Has a severe psychological disorder
• Has severe renal, cardiac, hepatic, etc. organ diseases (ASA IV or worse)
• Has a corneal endothelial cell count of less than 1000 cells/mm² in the study eye
• Has an implanted IOL in the study eye and a refraction of the study eye outside of -4D; +4D limit (this criterion is not relevant for phakic eyes)
• Has a highly myopic study eye (>26 mm AP)
• Has no light perception in either eye
• Has any signs of exudative AMD including exudative AMD with detachment of retinal pigment epithelium in the central visual field of the study eye
• Has an implanted telescope in one eye
• Has a black IOL in the study eye
• Presents with hypotonia in the study eye (<8 mmHg)
• Presents with hypertonia in the study eye (>23 mmHg with treatment)
• Is a known carrier of multi-resistant microorganisms
• Does not have the mental capacity to legally sign the informed consent
• Has head dimensions that are incompatible with the PRIMA Companion glasses
• Physical constraints making use of PRIMA or rehabilitation impossible
• Participant who, in the opinion of the investigator, is not suitable for participation in the study