Argus® II Retinal Stimulation System Feasibility Protocol
NCT ID: NCT00407602
Last Updated: 2022-01-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2006-09-30
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
NCT01860092
Observational Study of the Argus® II Retinal Prosthesis System
NCT01999049
Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye
NCT00063765
Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
NCT06852768
ERG/EOG Study in AMD Patients Treated With Ranibizumab
NCT00791427
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Implant of Argus II Retinal Prosthesis
This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.
Implant of Argus II Retinal Prosthesis
epiretinal implantation of device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Implant of Argus II Retinal Prosthesis
epiretinal implantation of device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Conditions likely to limit life to less than 1 year from the time of screening.
* Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning for the duration of the study (e.g. strabismus)
* Axial eye length \<21.5 mm or \>26.0 mm in the implanted eye as measured by ultrasound (US only)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Eye Institute (NEI)
NIH
Second Sight Medical Products
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne-Marie Ripley
Role: STUDY_DIRECTOR
Second Sight Medical Products
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.
Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.
Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.
Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.
Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.
Sabbah N, Authie CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.
Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.
de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.
Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.
Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9. doi: 10.1001/2013.jamaophthalmol.221.
Ahuja AK, Behrend MR. The Argus II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.
Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.
Perez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
National Eye Institute (NEI)
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CP-003-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.