Phase
Condition
Retinitis Pigmentosa
Posterior Uveitis
Eye Disorders/infections
Treatment
AuTNA I
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: 18-65 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 thanphotopic, even non response
impaired peripheral visual field in perimetry (when the patient's visionpermits).
No or suspicious light perception in the eye for AuTNA I implantation.
Intact inner retinal structure on OCT. No macular retinal or choroidalneovascularization.
Voluntary to participate in the study and sign the informed consent.
Exclusion
Exclusion Criteria:
Entities that might interfere with the functioning of AuTNA I, e.g. open oculartrauma, retinal detachment, glaucoma, severe uveitis, etc.
Uncontrolled systemic diseases including hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes (blood glucose ≥8.0mmol/L with medication);
Allergic constitution.
Entities that might prevent the observation of the fundus, e.g. corneal opacity,etc.
Ocular disease not suitable for undertaking the implantation surgery, e.g. cornealulcers, etc.
Habits of rubbing the eyes.
Compromised liver function (ALT and AST 1.5 times over the normal limits), renalfunction (Cr 1.5 times over the normal limits), coagulation function (APTT 1.5 timesover the normal limits).
Pregnancy, lactating or planning to be pregnant within 6 months.
History of epilepsy or serious psychiatric diseases.
Other local or systemic diseases that may affect the vision.
Participation in other clinical trials within 1 month before this study.
Other conditions that the researcher found imporper to be included into this study.
Study Design
Study Description
Connect with a study center
Chunhui Jiang
Shanghai, Shanghai 200030
ChinaActive - Recruiting
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