PRECISE
Research type
Research Study
Full title
Peeling of the ILM from the retinal surface with finesse forceps; the PRECISE study
IRAS ID
256842
Contact name
Roxanne Hillier
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN 70557873
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary
Macular holes (MH) are approximately half millimetre round defects in the very centre of the retina that form in some people as a result of age and result in loss of central vision and blindness. In 1991 it was shown that vitrectomy surgery could result in closure of the hole and improvement in vision and it is now one of the most common indications for retinal surgery with over 2500 operations carried out annually in the UK alone. \n\nDuring the surgery the internal limiting membrane (ILM) of the retina is routinely peeled off as this has been shown to improve the results of surgery. The ILM is a very fine 5-micron thick membrane and is peeled with specially designed forceps. When the membrane is peeled the inner surface of the retina can be damaged and some of these changes have been linked to where the forceps grasps the ILM during the peeling procedure. \n\nA new pair of forceps have been developed and CE marked to specifically improve the ease of picking up the ILM which should reduce any damage to the retina, but it is not known if this will definitely occur. We propose a feasibility study to analyse the effects of ILM peeling in a pilot randomised controlled trial of 66 patients undergoing ILM peeling for macular holes with conventional ILM peeling forceps that have been used for several years as compared to the new Forceps. \n\nThe study will concentrate on objective signs of retinal injury but will also assess surgeon related factors in a questionnaire as well as visual acuity and visual fields after surgery. Surgeons, postoperative vision and imaging assessors will be masked to the type of forceps used to reduce bias. The study will help inform a future full scale RCT of the use of the forceps.
Summary of Results
The study was carried out to assess the design of future studies investigating forceps used during surgery for macular holes. The study was also carried out to provide some initial evidence for the safety of a new type of forceps designed specifically to pick up the very fine membranes that are peeled form the retina to improve the results of the surgery. In the study the new type of forceps were compared with the existing forceps we have used for many years. The study was successfully carried out and the design of the study was felt to be very good. The study showed that the new forceps were safe and the surgeons didn't experience any problems with them. Both forceps were equally good at picking up the fine membranes required during surgery and the surgeons didn't find an additional benefit of the new forceps over the existing ones on any of the tests that were included in the study. We concluded that both forceps can be used equally well during surgery, and that the design of the study can be used to carry out future studies on the use of forceps with appropriate numbers of patients.
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0124
Date of REC Opinion
29 Jul 2019
REC opinion
Favourable Opinion