Observational Study of the Argus® II Retinal Prosthesis System

Retinitis Pigmentosa Clinical Trial

Official title:

Observational Study of the Argus® II Retinal Prosthesis System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999049
• Other study ID #: 50813
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2013
• Last updated: April 23, 2015
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2015
• Source: University Health Network, Toronto
• Contact: Robert Devenyi, MD
• Phone: 416-603-5602
• Email: rdevenyi[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Retinitis Pigmentosa

Locations

Country	Name	City	State
Canada	UHN Toronto Western Hospital 6E-438	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Foundation Fighting Blindness

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Epub 2013 Apr 12. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	No