Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
NCT ID: NCT00279500
Last Updated: 2023-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2002-02-27
2014-12-31
Brief Summary
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Detailed Description
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This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm study
Argus 16 Retinal Stimulation System-single arm study.
Argus 16 Retinal Stimulation System
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
Interventions
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Argus 16 Retinal Stimulation System
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
Eligibility Criteria
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Inclusion Criteria
* History of former useful form vision in worse-seeing eye
* Acceptable ability to describe visual percepts
* Age eighteen (18) or older
Exclusion Criteria
* Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage
* Presence of communicable disease/infection
* Pregnancy
* History of claustrophobia
* Inconsistent flash detection thresholds
* Any other diseases that can effect the function of the retina
* Subjects with a Beck Depression Inventory Interpretation score of \>30 and subsequent diagnosis of depression by a psychiatrist.
* Corneal degeneration
18 Years
ALL
No
Sponsors
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Second Sight Medical Products
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Olmos, MD
Role: PRINCIPAL_INVESTIGATOR
Doheny Eye Institute
Locations
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Doheny Eye Institute
Los Angeles, California, United States
Countries
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References
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Yue L, Wuyyuru V, Gonzalez-Calle A, Dorn JD, Humayun MS. Retina-electrode interface properties and vision restoration by two generations of retinal prostheses in one patient-one in each eye. J Neural Eng. 2020 Apr 9;17(2):026020. doi: 10.1088/1741-2552/ab7c8f.
Nanduri D, Fine I, Horsager A, Boynton GM, Humayun MS, Greenberg RJ, Weiland JD. Frequency and amplitude modulation have different effects on the percepts elicited by retinal stimulation. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):205-14. doi: 10.1167/iovs.11-8401.
Eng JG, Agrawal RN, Tozer KR, Ross-Cisneros FN, Dagnelie G, Greenberg RJ, Chader GJ, Weiland JD, Rao NA, Sadun AA, Humayun MS. Morphometric analysis of optic nerves and retina from an end-stage retinitis pigmentosa patient with an implanted active epiretinal array. Invest Ophthalmol Vis Sci. 2011 Jun 28;52(7):4610-6. doi: 10.1167/iovs.09-4936.
Horsager A, Boynton GM, Greenberg RJ, Fine I. Temporal interactions during paired-electrode stimulation in two retinal prosthesis subjects. Invest Ophthalmol Vis Sci. 2011 Feb 1;52(1):549-57. doi: 10.1167/iovs.10-5282. Print 2011 Jan.
Greenwald SH, Horsager A, Humayun MS, Greenberg RJ, McMahon MJ, Fine I. Brightness as a function of current amplitude in human retinal electrical stimulation. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5017-25. doi: 10.1167/iovs.08-2897. Epub 2009 Jul 15.
Caspi A, Dorn JD, McClure KH, Humayun MS, Greenberg RJ, McMahon MJ. Feasibility study of a retinal prosthesis: spatial vision with a 16-electrode implant. Arch Ophthalmol. 2009 Apr;127(4):398-401. doi: 10.1001/archophthalmol.2009.20.
Horsager A, Greenwald SH, Weiland JD, Humayun MS, Greenberg RJ, McMahon MJ, Boynton GM, Fine I. Predicting visual sensitivity in retinal prosthesis patients. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1483-91. doi: 10.1167/iovs.08-2595. Epub 2008 Dec 20.
de Balthasar C, Patel S, Roy A, Freda R, Greenwald S, Horsager A, Mahadevappa M, Yanai D, McMahon MJ, Humayun MS, Greenberg RJ, Weiland JD, Fine I. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2303-14. doi: 10.1167/iovs.07-0696.
Other Identifiers
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CP0002
Identifier Type: -
Identifier Source: org_study_id
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