Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinal Degeneration
- Sponsor
- Retina Implant AG
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Change in functional vision
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed Description
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires. This study adheres to the tenets of the Declaration of Helsinki.
Investigators
Eligibility Criteria
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))
- •Blindness in both eyes, (no light perception or light perception only)
- •Visual acuity sufficient for reading normal print in earlier life, optically corrected
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
- •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
- •Hyperthyroidism or hypersensitivity to iodine
- •Hypersensitivity to fluorescent dye
- •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
Outcomes
Primary Outcomes
Change in functional vision
Time Frame: baseline vs. 12 months after implantation
Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation
Secondary Outcomes
- Vision Related Quality of Life - Questionnaire(at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months))
- Adverse Events(2 years)
- Visual Function - Questionnaire(at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months))
- Measure of implant-mediated visual function(2 years)