Argus® II Retinal Stimulation System Feasibility Protocol
Completed · Not applicable
Conditions studied: Retinitis Pigmentosa
In brief
Investigational Phase of the Study: The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa. Post-Approval Phase of the Study: To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System
Key facts
- Study ID
- NCT00407602
- Run by
- Second Sight Medical Products
- People needed
- 30
- Starts
- 2006-09-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2022-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes.
- Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception.
- A history of former useful form vision in the worse-seeing eye.
- Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old
- Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site.
- Must be willing and able to comply with the protocol testing and follow-up requirements.
You may not qualify if…
- Optic Nerve disease
- History of glaucoma
- Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage
- Diseases or conditions that effect retinal function including but not limited to:
- Central retinal artery/vein occlusion (CRAO or CRVO)
- End-stage diabetic retinopathy
- Retinal detachment or history of retinal detachment
- Trauma
- Infectious or inflammatory retinal diseases
- Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant.
- Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions.
- Diseases of the ocular surface including but not limited to keratitis sicca.
- An ocular condition that predisposes the subject 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 neurological disease
- Psychiatric Disease including diagnosed forms of depression
- Does not speak a principal language associated with the region
- Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
- Pregnancy
- Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head
- Conjunctival thinning which may predispose the subject to conjunctival erosion in the area where the implant will be installed extra-ocularly.
- Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study
- Any health concern that makes general anesthesia inadvisable.
- Subject has unrealistic expectations of the implant.
- Known allergy or contraindication to anticipated pre-operative, intra-operative or post-operative medications.
Where it is running
- Doheny Eye Institute — Los Angeles, California, United States
- University of California San Francisco — San Francisco, California, United States
- Johns Hopkins, Wilmer Eye Institute — Baltimore, Maryland, United States
- Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute — New York, New York, United States
- University of Pennsylvania, Scheie Eye Institute — Philadelphia, Pennsylvania, United States
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States
- Retina Foundation of the Southwest — Dallas, Texas, United States
- Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12 — Paris, France
- Puerta de Hierro, Centro Medico, Centro de Retina — Zapopan, Jalisco, Mexico
- Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205 — Geneva, Switzerland
- Moorfields Eye Hospital, Vitreoretinal Research Unit — London, United Kingdom
- Manchester Royal Eye Hospital — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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