Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
surgical implantation of subretinal device
intra-individual implant OFF
Ophthalmology Eye Institute, University of Hong Kong
Hong Kong, Cyberport, Hong Kong
Safety
treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients
Time frame: 1 year
Efficacy
Activities of Daily Living \& Mobility are significantly improved with implant-ON versus OFF, as shown via tests: * Activities of Daily Living tasks or * Recognition tasks or * Mobility or * a combination of the above
Time frame: 1 year
Safety
Patient long term safety: * stability of implant function * stability of body structure \& function related to implant system
Time frame: 1 year
Efficacy
Visual Acuity / Light-perception and/or Object-recognition are significantly improved with implant-ON versus OFF as shown via: * FrACT or * BaLM or * Grating test (e.g. BaGA) and/or Quality of life * Quality of life (questionnaire) or * a combination of the above
Time frame: 1 year
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