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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single group assignment
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
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
Time frame: 12 months
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)
Time frame: 12 months
Efficacy of the Alpha AMS retinal implant system used for partial restoration of basic light detection..
Visual acuity or light-perception and/or object-recognition assessed with implant ON versus OFF via: • Basic Light and Motion test (BaLM)
Time frame: 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).
Time frame: 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.
Time frame: 12 months
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