Positioning in Macular Hole Surgery
Research type
Research Study
Full title
A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning with an inactive face-forward position on the outcome of surgery for large macular holes.
IRAS ID
162162
Contact name
James Bainbridge
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
A Macular hole is a blinding condition in which a hole develops in the central part of the retina, which is the layer of light-sensitive of nerves in the eye. The condition causes sight loss in approximately 2 in every 1000 individuals and can have a devastating impact on quality of life and independence.
The condition is believed to result from pulling on the retina by the vitreous gel that fills the eye; it is treated by surgical removal of the vitreous gel to relieve these forces, and injection of a gas bubble to promote closure of the hole.
Following surgery, patients may be advised to maintain a face-down position (with the eyes directed straight down) for up to 10 days with the aim of improving the likelihood of successful hole closure by maintaining contact of the gas bubble with the macular hole. However, face-down positioning can be uncomfortable and we do not know if it is actually required to ensure a successful outcome.
The aim of the proposed research is to determine the value of advice to position face-down following surgery for large macular holes. We will perform a trial to compare the success of surgical repair in 96 people advised to position face-down for 5 days (8 hours per day) with the outcome in 96 people advised to adopt an inactive face-forward position for a similar period.
The research team combines the strengths of experienced eye specialists with the expertise of the Pragmatic Clinical Trials Unit, and the active involvement of patients to ensure that the trial addresses their needs.
The trial will benefit patients by providing reliable information on the value of positioning following surgery for large macular holes, thereby enabling them to make an appropriately informed choice about the management of their condition.
REC name
London - Westminster Research Ethics Committee
REC reference
14/LO/2061
Date of REC Opinion
3 Dec 2014
REC opinion
Favourable Opinion