Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT01999049

Conditions

Retinitis Pigmentosa

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Retinitis Pigmentosa

Study ID

NCT01999049

Start date

Apr, 2014

Status verified date

Apr, 2015

Completion date

Jan, 2017

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Robert Devenyi, MD

416-603-5602rdevenyi@gmail.com

Locations

UHN Toronto Western Hospital 6E-438

Recruiting

Toronto, Ontario, Canada, M5t 2S8

Principal Investigator:

Robert Devenyi, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 24, 2015

Last verified

Apr, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2015-04-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.