Clinical trial NCT00279500: Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Official title: Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects with a confirmed history of advanced retinal degenerative disease and meeting the inclusion criteria listed will be considered as eligible participants in the study. Subjects who have a condition listed in the exclusion criteria will not be allowed to participate in the study. Eligible subjects with the above diagnoses will be recruited from the Doheny Eye Institute at the University of Southern California. Additionally, new subjects encountered in the clinic who fulfill the inclusion criteria will also be eligible to participate. Upon meeting the entry criteria, all subjects must sign an Informed Consent prior to enrollment in the study. Since the subjects are blind, an individual not associated with this study must read the informed consent to the subject. This person must sign the consent form as a witness to the informed consent process.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery.
* History of former useful form vision in worse-seeing eye
* Acceptable ability to describe visual percepts
* Age eighteen (18) or older

Exclusion Criteria:

* History of glaucoma
* 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

Primary outcomes:
measure: Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
timeFrame: From 2 weeks post-op until end of device usage, up to 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Doheny Eye Institute
state: California
Study officials:
affiliation: Doheny Eye Institute
name: Lisa Olmos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.