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| Name | Class |
|---|---|
| Fudan University | OTHER |
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The objective of the study is to evaluate:
In this study, AuTNA I (nanoparticle-decorated TiO2 Nanowire Arrays), which is designed to replace the damaged photoreceptors in RP patients, was implanted in one eye of the subjects. The change or improvement in the visual acuity of the subjects, as well as the potential side effects, was then fully evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant AuTNA I | Experimental | This is a single arm study where the status and performance of the implanted eye prior to the surgery serves as the comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AuTNA I | Device | AuTNA I means Au nanoparticle-decorated TiO2 Nanowire Arrays, a retinal prothesis designed for subretinal implantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FST | FST means Full-field Sensitivity Threshold. The thresholds of light with different wavelengths. The exam was performed at baseline and at various time points throughout the first year after the implantation. | Baseline and improvement of FST at 3 months. |
| BCVA | BCVA means Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision. It's performed at baseline and at various timepoints throughout the first year after the implantation. | Baseline and improvement of BCVA at 3 months. |
| Clinical electrophysiology of vision | Electrophysiological examinations of the visual pathway to evaluate the light responsiveness, including VEP, ERG and mfERG (Multifocal ERG). It's performed at baseline and at various timepoints throughout the first year after the implantation. | Baseline and improvement of electrophysiology at 3 months. |
| ElectroEncephaloGram | EEG(ElectroEncephaloGram) target frequency power amplitude and signal-to-noise ratio (SNR) would be used to analyse the visual stimulus steady-state evoked potential paradigms. It's performed at baseline and at various timepoints throughout the first year after the implantation. | Baseline and change of EEG at 3 months. |
| Functional Magnetic Resonance Imaging | Using fMRI (Functional Magnetic Resonance Imaging) to measure visual stimulus-induced brain activity caused by changes in blood flow. It's performed at baseline and at various timepoints throughout the first year after the implantation. | Baseline and change of fMRI at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual field | The visual sensitivity of the implantation site of the fundus is measured with microfield perimetry. It's performed at baseline and at various timepoints throughout the first year after the implantation. | Recruitment (baseline) and 3 months, 6 months and 1 year after implantation. |
| Line task |
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Inclusion Criteria:
Age: 18-70 years of age.
Clinically diagnosed as retinitis pigmentosa (one of the following two conditions):
â‘ typical triadfundus manifestations: "osteoblastic" pigmentation of retina, arterial stenosis, and waxy atrophy of optic disc.
â‘¡ typical fundus changes with both a and b, with or without c:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunhui Jiang | Contact | +8621-64377134-2501 | chhjiang70@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunhui Jiang | Eye and ENT Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chunhui Jiang | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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To record the completion (completed/failed, time course if completed) of walking along a five-meter-long white strip on the black floor in a well-illuminated environment. It's performed at baseline and at various timepoints throughout the first year after the implantation. |
| Recruitment (baseline) and 3 months, 6 months and 1 year after implantation. |
| VisQoL | Vision-related quality of life is assessed with the VisQoL (Vision and Quality of Life) scale. It's performed at baseline and at various timepoints throughout the first year after the implantation. | Recruitment (baseline) and 3 months, 6 months and 1 year after implantation. |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |