Pilot Study of AuTNA I

Ki vehet részt

• Age: 18-70 years of age
• Clinically diagnosed as retinitis pigmentosa (one of the following two conditions):; ① typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc; ② typical fundus changes with both a and b, with or without c:; poor night vision before vision loss; standard 5 ERG examination showing more severely damaged scotopic response than photopic, even non response; impaired peripheral visual field in perimetry (when the patient's vision permits)
• No or suspicious light perception in the eye for AuTNA I implantation
• Intact inner retinal structure on OCT. No macular retinal or choroidal neovascularization
• Voluntary to participate in the study and sign the informed consent

Ki nem vehet részt

• Participation in other clinical trials within 1 month before this study
• Allergic constitution
• Ocular disease not suitable for undertaking the implantation surgery, e.g. corneal ulcers, etc
• History of epilepsy or serious psychiatric diseases
• Other local or systemic diseases that may affect the vision
• Other conditions that the researcher found imporper to be included into this study
• Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication)
• Compromised liver function (ALT and AST 1.5 times over the normal limits), renal function (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 times over the normal limits)
• Entities that might interfere with the functioning of AuTNA I, e.g. open ocular trauma, retinal detachment, glaucoma, severe uveitis, etc
• Entities that might prevent the observation of the fundus, e.g. corneal opacity, etc
• Habits of rubbing the eyes
• Pregnancy, lactating or planning to be pregnant within 6 months