MIRROR Trial version 1.0
Research type
Research Study
Full title
Efficacy of the Telescopic Mirror Implant for Age-related Macular Degeneration: The MIRROR Trial (acronym MIRROR). A Multicentre Randomised Controlled Clinical Trial.
IRAS ID
180558
Contact name
Giuliana Silvestri
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
ISRCTN Number
ISRCTN47403123
Clinicaltrials.gov Identifier
2016-000887-40, EudraCT
Duration of Study in the UK
3 years, 5 months, 28 days
Research summary
Approximately 600,000 individuals in the UK with age-related macular degeneration (AMD) are visually impaired. Despite the availability of new improved treatments by injection for the “wet” form of AMD, no treatment exists for “atrophic or dry” AMD or for those who fail to respond to treatment. A recent approach has been the use of an implantable magnifying lens into the eye. These devices placed inside the eye at the time of cataract surgery or as a separate procedure have several potential advantages - more natural scanning technique and are more cosmetically appealing. A novel device (OriLens) uses mirrors in its design which allows a significant reduction in the size of the device but maintains a high magnification and allows less reduction of peripheral visual field. The reduced size of telescope also offers the potential for an easier and safer surgery and faster recovery than other telescopes currently available. The aim of this trial is to provide good quality evidence regarding the efficacy and safety of this device.\n\nThe study will involve 132 people with severe sight loss from AMD who have had cataract surgery, across 10 sites in the UK, over a 42 month period. Once confirmed that they fulfil the inclusion criteria, all participants will undergo laser treatment to the study eye unless this has already been carried out. Participants will be randomised equally to one of two groups. Group 1 will undergo implantation of the OriLens as a secondary surgical procedure. Both groups will have refraction, be provided with any necessary supplementary spectacles and low vision aids (LVAs), and have three sessions of low vision training. \n\nThe main outcome will be distance visual acuity after one year, but this study will compare a set of measurable outcomes, including near acuity, reading speed, quality of life, and safety. \n
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
16/EM/0212
Date of REC Opinion
23 May 2016
REC opinion
Favourable Opinion