Pilot Study of AuTNA I (Au Nanoparticle-decorated TiO2 Nanowire Arrays, Retinal Prothesis) -a Safety and Efficacy Evaluation.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chunhui Jiang
RECRUITING
Shanghai
Contact Information
Primary
Chunhui Jiang
chhjiang70@163.com
+8621-64377134-2501
Time Frame
Start Date: 2023-05-12
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 7
Treatments
Experimental: Implant AuTNA I
This is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator.
Sponsors
Leads: Eye & ENT Hospital of Fudan University
Collaborators: Fudan University

This content was sourced from clinicaltrials.gov

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