NCT00279500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 17, 2018

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2018

Enrollment Period

12.8 years

First QC Date

January 17, 2006

Results QC Date

June 14, 2017

Last Update Submit

April 10, 2023

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events From 2 Weeks Post-op Until the End of the Study

    All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.

    From 2 weeks post-op until end of device usage, up to 10 years.

Study Arms (1)

single arm study

EXPERIMENTAL

Argus 16 Retinal Stimulation System-single arm study.

Device: Argus 16 Retinal Stimulation System

Interventions

Argus 16 Retinal Stimulation SystemDEVICE

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.

single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

Related Publications (8)

  • 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.

    PMID: 32131056DERIVED

  • 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.

    PMID: 22110084DERIVED

  • 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.

    PMID: 21296811DERIVED

  • 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.

    PMID: 20720224DERIVED

  • 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.

    PMID: 19608533DERIVED

  • 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.

    PMID: 19365014DERIVED

  • 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.

    PMID: 19098313DERIVED

  • 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.

    PMID: 18515576DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Jessy Dorn, PhD, Director, Clinical and Scientific Research
Organization
Second Sight Medical Products, Inc.
jdorn@secondsight.com
8188335089

Study Officials

  • Lisa Olmos, MD

    Doheny Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

February 27, 2002

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

April 12, 2023

Results First Posted

May 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)