Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.
The objective of the study is to evaluate: 1. Safety of AuTNA I for subretinal implantation in patients with retinitis pigmentosa; 2. Efficacy of AuTNA I for subretinal implantation in patients with retinitis pigmentosa.
• 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.