Protocol WA-NG-001 EUROPE REV 1 , November 2018
Research type
Research Study
Full title
STUDY OF THE WA-NG (NG-IMT) TELESCOPE PROSTHESIS IN PATIENTS WITH CENTRAL VISION IMPAIRMENT ASSOCIATED WITH END-STAGE AGE-RELATED MACULAR DEGENERATION
IRAS ID
248292
Contact name
Felipe Dhawahir-Scala
Contact email
Sponsor organisation
VisionCare Ophthalmic Technologies
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
1 years, 9 months, 3 days
Research summary
The purpose of this study is to evaluate the safety of the Model WA-NG telescope prosthesis, an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration (AMD).
The WA-NG telescope prosthesis which, together with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity, it is intended to improve distance and near vision. The device is implanted in one of the patient’s eyes. This eye provides central vision and the non-implanted eye continues to provide peripheral vision.Macular degeneration, the breakdown of cells in the centre of the retina (macula) is the most common form of macular dystrophies which are the leading cause of central vision impairment and blindness.
AMD affects 1% of all 55-year-olds, and the incidence increases with age, reaching approximately 15% among those aged 80 and over.
AMD reduces the ability of the individual to engage in activities that require clear central vision. It is associated with elevated risk of depression, dependency, and a decrease in the quality of life.
Patients with bilateral moderate to profound central vision impairment due to end-stage AMD will be eligible for this study. Patients must be at least 65 years of age, have not had cataract surgery in the operative eye. They must meet the inclusion criteria and be available for the study duration of 12 months.
The study will be carried out at the Manchester Royal Eye Hospital.The duration of the study is 12 months. Each patient will undergo an initial evaluation process. Suitable patients will undergo implant surgery in an outpatient setting. The implanted eye and the patient’s vision will be examined at 9 follow-up visits. In addition the patient will attend up to 10 visits for vision training with a low vision specialist.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0009
Date of REC Opinion
12 Feb 2019
REC opinion
Further Information Favourable Opinion