Status:
COMPLETED
Post-Market Study of the Argus® II Retinal Prosthesis System - France
Lead Sponsor:
Second Sight Medical Products
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
25+ years
Brief Summary
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...
Detailed Description
This study is a controlled, prospective, multi-centre, single-arm post-market study. All data collected will be obtained from procedures that are performed as part of routine patient case and from non...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
November 20 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02303288
Start Date
November 20 2014
End Date
November 20 2018
Last Update
June 22 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33000
2
Centre hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France, 75571
3
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091