Retinitis Pigmentosa Clinical Trial
Official title:
Post-Market Study of the Argus® II Retinal Prosthesis System - France
Verified date | June 2020 |
Source | Second Sight Medical Products |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 20, 2018 |
Est. primary completion date | March 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years and older |
Eligibility |
Inclusion Criteria: - Are adults, age 25 years or older; - Have retinitis pigmentosa with visual acuity of bare light perception or worse in both eyes; - Have previous history of useful form vision; - If the subject has no residual light perception, the retina must be able to respond to electrical stimulation; - The subject is willing to provide written, informed consent to participate in the study. Exclusion Criteria: - Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.); - Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.); - Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity); - Pre-disposition to eye rubbing; - Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: - cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease, - psychiatric disease including diagnosed forms of depression; - does not speak a principal language associated with the region, and - deafness or selective frequency hearing loss that prevents hearing device alarms and alerts; - Pregnant or wish to become pregnant during the course of the study; - Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study; - Conditions likely to limit life to less than 1 year from the time of inclusion; - At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.). Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.); - Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.); - Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity); - Pre-disposition to eye rubbing; - Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: - cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease, - psychiatric disease including diagnosed forms of depression; - does not speak a principal language associated with the region, and - deafness or selective frequency hearing loss that prevents hearing device alarms and alerts; - Pregnant or wish to become pregnant during the course of the study; - Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study; - Conditions likely to limit life to less than 1 year from the time of inclusion; - At the time of the Baseline Visit, suffering from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.). |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Bordeaux | Bordeaux | |
France | Centre hospitalier National d'Ophtalmologie des Quinze-Vingts | Paris | |
France | Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Second Sight Medical Products |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Vision - FLORA | The impact of the Argus II on subjects' lives (in terms of functional vision and quality of life) as measured by the Functional Low-vision Observer Rated Assessment (FLORA) | 2 Years | |
Primary | Adverse events | Incidence of procedure- and device-related adverse events | 2 Years | |
Secondary | Patient Satisfaction and ease of use of the System | A questionnaire will be administered to track how satisfied or dissatisfied subjects are with the Argus II System, how frequently they use the system, how easy or difficult they think the system is to use, and the ways in which they use the System outside the clinic. | 2 years | |
Secondary | Visual Function | Visual function will be assessed using the following tests: Square Localization: This test assesses subject's light projection. Direction of Motion: This test indicates a subject's ability to detect the direction of a moving object. Grating Visual Acuity: This test is designed to determine a subject's visual acuity using the principles of acuity charts such as ETDRS, modified for extremely low vision. It measures visual acuity between 1.6 to 2.9 logMAR. Subjects' performance on the 3 tests above will be compared: o Pre-vs. post-implant and. With the Argus II System ON vs. OFF |
2 years | |
Secondary | Functional Vision | The National Eye Institute Visual Function Questionnaire (VFQ-25) will be administered to obtain subjects' self-reported assessment of their vision and what tasks they can perform with their vision (i.e. vision-targeted health status). | 2 years | |
Secondary | Explantation rate | Measure device reliability through explantation rates | 2 years |
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