Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS (NCT03561922) | Clinical Trial Compass
TerminatedNot Applicable
Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Stopped: Manufacturer of the investigational device has ceased all business activities
France2 participantsStarted 2018-09-04
Plain-language summary
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.
Who can participate
Age range18 Years – 78 Years
SexALL
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Inclusion criteria
✓. Age 18 to 78
✓. Willing and able to give written informed consent
✓. Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods \& cones)
✓. Pseudophakia or aphakia in the eye to be implanted
✓. Retinal vessels with remaining perfusion, despite pathological condition
✓. Layering of inner retina in the central region present, as shown by Optical Coherence Tomography (OCT)
✓. Thickness of the retina sufficient for subretinal surgery as shown by OCT
✓. Inner retina still functional (proven e.g. by light perception or electrically evoked phosphenes (EEP))
Exclusion criteria
✕. OCT shows significant retina edema and/or scar tissue within target region for implant
✕. Heavy clumped pigmentation at posterior pole or on the planned route of the implantation
✕. atrophy of optic nerve or ganglion cells degeneration
✕. Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment)
✕. Deep amblyopia reported earlier in life on eye to be implanted
What they're measuring
1
Change in functional vision
Timeframe: baseline vs. 12 months after implantation
✕. Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases)
✕. Acute and severe neurological and/or psychiatric diseases