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Health Condition(s) or Problem
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Retinitis Pigmentosa; Retinal Degeneration
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Lay Summary
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Patients suffering from hereditary retinal degeneration receive a retinal implant to restore
sight.
Subretinal implant "ON" results in significant visual acuity improvement, when compared to
"OFF" condition.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods &
cones.
- Pseudophakia
- Angiography shows retinal vessels adequately perfused, despite pathological RP
condition.
- Age between 18 and 78 years.
- Blindness (at least monocular) i.e. visual functions not appropriate for localization
of objects, self sustained navigation and orientation.
- Ability to read normal print in earlier life, optically corrected without magnifying
glass.
- Willing and able to give written informed consent in accordance to EN ISO 14155
(section 6.7) and local legislation prior to participation in the study. Able to
perform the study during the full time period of one year for Module-2.
Exclusion Criteria:
- Period of appropriate visual functions approx. 12 years / lifetime.
- Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue
within target region for implant.
- Retina detected as too thin to expect required rest-functionality of inner retina as
shown via Optical Coherence Tomography (OCT).
- Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes
(EEP).
- Heavy clumped pigmentation at posterior pole
- Any other ophthalmologic disease with relevant effect upon visual function (e.g.
glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
- Amblyopia reported earlier in life on eye to be implanted
- Systemic diseases that might imply considerable risks with regard to the surgical
interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe
metabolic diseases).
- Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
- Hyperthyroidism or hypersensitivity to iodine
- Women who are pregnant or nursing, or women of childbearing potential who are not
willing to use a medically acceptable means of birth control for the duration of the
study, or women unwilling to perform a pregnancy test before entering the study.
- Participation in another interventional clinical trial within the past 30 days.
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Who cannot enter the trial
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Inclusion Criteria:
- Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods &
cones.
- Pseudophakia
- Angiography shows retinal vessels adequately perfused, despite pathological RP
condition.
- Age between 18 and 78 years.
- Blindness (at least monocular) i.e. visual functions not appropriate for localization
of objects, self sustained navigation and orientation.
- Ability to read normal print in earlier life, optically corrected without magnifying
glass.
- Willing and able to give written informed consent in accordance to EN ISO 14155
(section 6.7) and local legislation prior to participation in the study. Able to
perform the study during the full time period of one year for Module-2.
Exclusion Criteria:
- Period of appropriate visual functions approx. 12 years / lifetime.
- Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue
within target region for implant.
- Retina detected as too thin to expect required rest-functionality of inner retina as
shown via Optical Coherence Tomography (OCT).
- Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes
(EEP).
- Heavy clumped pigmentation at posterior pole
- Any other ophthalmologic disease with relevant effect upon visual function (e.g.
glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
- Amblyopia reported earlier in life on eye to be implanted
- Systemic diseases that might imply considerable risks with regard to the surgical
interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe
metabolic diseases).
- Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
- Hyperthyroidism or hypersensitivity to iodine
- Women who are pregnant or nursing, or women of childbearing potential who are not
willing to use a medically acceptable means of birth control for the duration of the
study, or women unwilling to perform a pregnancy test before entering the study.
- Participation in another interventional clinical trial within the past 30 days.
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What will happen
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Device; Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye; Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially.
Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.; retinal implant; bionic eye; artificial vision; artificial eye; restoration of vision; eye chip; vision prosthesis; eye implant; retinal prosthesis
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Primary aim
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Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.
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Secondary Aim
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Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.; every 3 months for a period of one year; Yes; Patient long term safety and stability of implant function; every 3 months for a period of one year; Yes
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London, Oxford
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