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The aim of this single-centre study is to assess the safety and efficacy of the Retina Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The study is sponsored by the University of Oxford and funded by the National Institute for Health Research (UK).
The specific research questions are, i) can the implant partially restore vision to an eye with no light perception and ii) what are the safety implications for the ocular and periorbital tissues of the implanted eye? In advanced RP the light detecting photoreceptor cells of the retina degenerate slowly over time, and may eventually lead to blindness. The subretinal implant replaces the degenerate photoreceptor layer and stimulates the residual overlying healthy retinal layers in response to a light stimulus. These signals are then carried on to the brain along the normal visual pathway. Investigators are seeking to recruit six participants who fulfill the eligibility criteria, which include advanced RP with no useful light perception vision in the eye to receive the implant. Participants must be aged between 18 and 70 years old, be highly motivated, and be well enough for a general anaesthetic. The eye must have also had cataract surgery. The project will be conducted at the Oxford Eye Hospital. Those participants selected to receive the implant will be followed for 12 months from the date of surgery. Between week 1 and month 12 there will be at least 7 outpatient clinic visits for a range of visual tests and eye assessments. After 12 months the trial will officially end, however investigators will continue to review all research participants in clinic as would be standard care for a patient with RP. The implant may be removed at any stage e.g. when it ceases to function or at the participant's request.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant 'on' vs implant 'off' | Experimental | Intra-individual comparison of implant 'on' vs implant 'off' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant 'on' vs implant 'off' | Device | Single group assignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Alpha AMS retinal implant system used for activities of daily living tasks. | Activities of daily living are assessed with implant ON versus OFF via: • Activities of daily living tasks | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Alpha AMS retinal implant system used for partial restoration of visual acuity. | Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via • Freiburg visual Acuity and Contrast Test (FrACT) | 12 months |
| Efficacy of the Alpha AMS retinal implant system used for partial restoration of basic light detection.. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E MacLaren, DPhil FRCS | 1. Nuffield Laboratory of Ophthalmology, Department of Clinical Neurosciences, University of Oxford; 2. Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust; 3. Moorfields Eye Hospital NHS Foundation Trust, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32343050 | Derived | Cehajic Kapetanovic J, Troelenberg N, Edwards TL, Xue K, Ramsden JD, Stett A, Zrenner E, MacLaren RE. Highest reported visual acuity after electronic retinal implantation. Acta Ophthalmol. 2020 Nov;98(7):736-740. doi: 10.1111/aos.14443. Epub 2020 Apr 28. | |
| 28878616 | Derived | Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kuhlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schroder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017. |
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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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| ID | Term |
|---|---|
| D057488 | Visual Prosthesis |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via: • Basic Light and Motion test (BaLM) |
| 12 months |
| Efficacy of the Alpha AMS retinal implant system used for partial restoration of grating acuity. | Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via: • Basic Grating Acuity test (BaGA). | 12 months |
| Safety of the Alpha AMS retinal implant. | The number of participant with Adverse Events and/or Serious Adverse Events, as defined by the Study Protocol, will be reported. | 12 months |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |