Clinical trial NCT01999049: Observational Study of the Argus® II Retinal Prosthesis System
Official title: Observational Study of the Argus® II Retinal Prosthesis System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinitis Pigmentosa
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Foundation Fighting Blindness
First posted: 2013-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe to profound outer retinal degeneration

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.

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.

Eligibility 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.

Primary outcomes:
measure: Safety
timeFrame: Patients will be observed for 1 year post-implant.
Secondary outcomes:
measure: Visual function
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: UHN Toronto Western Hospital 6E-438
state: Ontario
Study officials:
affiliation: University Health Network- Toronto Western Hospital
name: Robert Devenyi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.