Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a randomised controlled trial: FILMS (Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study)

A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Interna...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2008-11, Vol.9 (1), p.61-61, Article 61
Main Authors: Lois, Noemi, Burr, Jennifer, Norrie, John, Vale, Luke, Cook, Jonathan, McDonald, Alison
Format: Article
Language:English
Subjects:
Care and treatment
Clinical trials
Consent
Diabetes
Diabetic retinopathy
Diagnosis
Eye
Health aspects
Macular degeneration
Membranes
Methods
Patient outcomes
Patients
Quality of life
Retina
Study Protocol
Surgeons
Surgery
Visual acuity
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Summary:A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Internal limiting membrane (ILM) peeling has been introduced as an additional surgical manoeuvre to increase the success of the surgery; i.e. increase rates of hole closure and visual improvement. However, little robust evidence exists supporting the superiority of ILM peeling compared with no-peeling techniques. The purpose of FILMS (Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study) is to determine whether ILM peeling improves the visual function, the anatomical closure of FTMH, and the quality of life of patients affected by this disorder, and the cost-effectiveness of the surgery. Patients with stage 2-3 idiopathic FTMH of less or equal than 18 months duration (based on symptoms reported by the participant) and with a visual acuity
ISSN:1745-6215
1468-6694
1745-6215
DOI:10.1186/1745-6215-9-61