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Observational Study of the Argus® II Retinal Prosthesis System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01999049
Recruitment Status : Unknown
Verified April 2015 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : December 3, 2013
Last Update Posted : April 24, 2015
Sponsor:
Collaborator:
Foundation Fighting Blindness
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Study of the Argus® II Retinal Prosthesis System
Study Start Date : April 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Safety [ Time Frame: Patients will be observed for 1 year post-implant. ]
    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.


Secondary Outcome Measures :
  1. Visual function [ Time Frame: 1 year ]
    • 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe to profound outer retinal degeneration
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999049


Contacts
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Contact: Robert Devenyi, MD 416-603-5602 rdevenyi@gmail.com

Locations
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Canada, Ontario
UHN Toronto Western Hospital 6E-438 Recruiting
Toronto, Ontario, Canada, M5t 2S8
Principal Investigator: Robert Devenyi, MD         
Sponsors and Collaborators
University Health Network, Toronto
Foundation Fighting Blindness
Investigators
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Principal Investigator: Robert Devenyi, MD University Health Network- Toronto Western Hospital
Publications:
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01999049    
Other Study ID Numbers: 50813
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn