Patients with retinitis pigmentosa or advanced AMD
Conditions
Interventions
three:Implantation Procedure of the Implantable Retinal Microcurrent Stimulator
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 80 years at enrollment; 2.Diagnosed with retinitis pigmentosa (RP) with poor bilateral visual acuity (2.9 logMAR or worse); OR diagnosed with age-related macular degeneration (AMD) with absent central macular vision in both eyes and residual visual acuity of 1.3 logMAR or worse; 3.Presence of visual function in both eyes confirmed by visual neurophysiological examinations; 4.The worse-seeing eye has light perception, with documented prior form vision experience; 5.Absence of refractive media opacities and/or pupillary abnormalities that would interfere with implantation surgery or fundus examination; 6.Signed informed consent form, and willingness to attend follow-up visits, device fitting and low vision training at the timepoints specified in the trial;
Exclusion criteria
Exclusion criteria: 1.Subjects meeting ANY of the following ocular conditions shall be excluded: (1) Optic nerve diseases: a) Glaucoma; b) Optic neuritis, ischemic optic neuropathy, optic neuropathy secondary to intracranial lesions, drug-induced optic neuropathy, or other confirmed visual cortex injury; 2.Diseases or conditions impairing retinal function, including but not limited to: a) Central retinal artery/vein occlusion (CRAO/CRVO); b) Advanced diabetic retinopathy; c) Retinal detachment or prior history of retinal detachment; d) Ocular trauma; e) Infectious or inflammatory retinal diseases; 3.Diseases or conditions precluding adequate visualization of the retina, including but not limited to untreatable cataract or corneal degeneration at baseline examination (treatable cataract excluded); 4.Anterior segment diseases or conditions that hinder implantation surgery or comprehensive ocular examination, including but not limited to ocular trauma, eyelid malposition, etc.; 5.Ocular surface diseases that may compromise conjunctival healing, including but not limited to keratoconjunctivitis sicca and corneal ulcer; 6.Subjects with habitual eye-rubbing tendency or relevant ocular conditions; 7.Axial length of the implant eye 26.0 mm measured by ocular ultrasound; 8.Intraocular pressure (IOP) of the implant eye 22 mmHg (ocular hypertension); 9.Fundus fluorescein angiography (FFA) demonstrating poor perfusion of central retinal artery and vein as well as posterior pole retina, and/or macular neovascularization (MNV); 10.Subjects with extensive pigmentation in the macular region of the posterior pole retina, which, in the Investigator’s opinion, may interfere with normal function of the implant; 11.Diseases or conditions judged by the Investigator to impede implantation of the retinal implant (e.g., strabismus, thin conjunctiva), or conditions that may affect implant function (e.g., nystagmus); 12.Subjects meeting ANY of the following systemic diseases shall be excluded: Any disease or condition rendering the subject incapable of understanding informed consent, study requirements and testing protocols, including: a) Cognitive decline, including diagnosed dementia and/or progressive neurological diseases; b) Severe psychiatric disorders; c) Hearing impairment that may prevent the subject from hearing device alarms; 13.Any physical condition precluding tolerance of local or general anesthesia; 14.History of allergy or contraindication to the investigational device and related therapeutic medications; 15.History of epilepsy; 16.History of stroke, myocardial infarction and/or cerebrovascular events, transient ischemic attack within 30 days prior to screening; active disseminated intravascular coagulation or obvious bleeding tendency; 17.Patients with systemic autoimmune diseases (e.g., ankylosing spondylitis, systemic lupus erythematosus, Behçet’s disease, rheumatoid arthritis, scleroderma, etc.); 18.Uncontrolled or untreatable HIV infection, active hepatitis, severe psychiatric, neurological, cardiovascular, respiratory diseases, malignant tumors, etc.; 19.Hypertensive patients with poorly controlled blood pressure (defined as systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg despite antihypertensive medication); 20.Surgical history within 1 month prior to screening, or existing unhealed wounds, ulcers, fractures, etc.; 21.Long-term use of antimetabolites or anticoagulants, which is dee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity (BCVA);Amsler grid localization accuracy;localization accuracy;Incidence of Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Evoked Potential (VEP) testing;Object grasping ability test.;Straight?line walking test;Letter Identification Test; | — |
Countries
China
Contacts
Public ContactZhang Yun
Eye Hospital, Wenzhou Medical University
Outcome results
None listed