Observational Study of the Argus® II Retinal Prosthesis System

The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients who are blind from retinal degeneration - retinitis pigmentosa. These patients have no alternatives. Patients typically can achieve ambulatory vision.

Study Overview

• Status: Unknown
• Conditions: Retinitis Pigmentosa

Detailed Description

This study is an investigator-sponsored, observational, controlled, prospective, single-center study. The purpose of this current study is how it affects people's visual function and activities of daily living and to collect additional data on Argus II users in order to monitor the System's safety. In addition, data about the long-term reliability of the System will be gathered.

The Argus II retinal implant will be surgical implanted into patients who are blind but the surgical procedure is not a part of this observational study. Our hypothesis is that the visual results in our hands will be comparable to those reported in the FDA study. We will use the results of this study to plan future enhancements to the service and to explore the use of the device for other blinding conditions.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Robert Devenyi, MD; Phone Number: 416-603-5602; Email: rdevenyi@gmail.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5t 2S8
      • Recruiting
      • UHN Toronto Western Hospital 6E-438
      • Principal Investigator: Robert Devenyi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe to profound outer retinal degeneration

Description

Inclusion Criteria:

•Adults, age 25 years or older with severe to profound outer retinal degeneration.

but some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation and previous history of useful form vision.

Exclusion Criteria:

• Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus).
• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length <20.5 mm or > 26 mm, corneal ulcers, choroidal neovascularisation in the area of the intended tack location, etc.).
• Ocular diseases or conditions (other than cataracts) that prevent adequate visualisation of the inner structures of the eye (e.g. corneal opacity, etc.).
• Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery.
• Predisposition to eye rubbing.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	The primary endpoint in the study is safety. Safety will be assessed by calculating the proportion of subjects who experience individual procedure- and device-related adverse events. In addition, the proportion of subjects who experience a significant ocular event will also be reported.	Patients will be observed for 1 year post-implant.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual function	Visual function: Visual function means how the eye works (e.g. visual acuity). Visual function will be measured using the following tests: Square Localization; Direction of Motion; Grating Visual Acuity (GVA).; Functional vision: Functional vision means how subjects perform in vision-related activities of daily living. Function vision will be assessed using the Functional Low-Vision Observer Rated Assessment (FLORA). A utilization questionnaire will also be administered to track how subjects are using the Argus II System.	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Foundation Fighting Blindness
• Investigators: Principal Investigator: Robert Devenyi, MD, University Health Network- Toronto Western Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: 50813