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)

Noemi Lois, Jennifer Burr, John Norrie, Luke Vale, Jonathan Cook, Alison McDonald, Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group, Hatem Atta, Charles Boachie, John Forrester, Karon McEwing, Laura Duncan, Ayyakkawnv Manivannan, Gladys McPherson, Laura Ternent, Alison Farrow, Andrew Dick, Richard Haynes, Cherry Daly, Gillian Bennerson, Stephen Neilson, Dara Kilmartin, Catherine Cleary, Tarik Saddik, John Ellis, Stan Keys, Jim Talbot, Ian Pearce, Carl Groenewald, David Wong, Henrich Heimann, Valerie Tompkin, Ronnie Jackson, C K Patel, Charles Cottriall, Lynda Lindsell, Anne Bolton, David Steel, Sarah Muir, Anita Murphy, Terri Ainsley, Stephen Beatty, Asif Orakzai, Ayman Saeed, Muhammad Irfan Khan, Adrian Gran, Noemi Lois, Jennifer Burr, John Norrie, Luke Vale, Jonathan Cook, Alison McDonald, Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group, Hatem Atta, Charles Boachie, John Forrester, Karon McEwing, Laura Duncan, Ayyakkawnv Manivannan, Gladys McPherson, Laura Ternent, Alison Farrow, Andrew Dick, Richard Haynes, Cherry Daly, Gillian Bennerson, Stephen Neilson, Dara Kilmartin, Catherine Cleary, Tarik Saddik, John Ellis, Stan Keys, Jim Talbot, Ian Pearce, Carl Groenewald, David Wong, Henrich Heimann, Valerie Tompkin, Ronnie Jackson, C K Patel, Charles Cottriall, Lynda Lindsell, Anne Bolton, David Steel, Sarah Muir, Anita Murphy, Terri Ainsley, Stephen Beatty, Asif Orakzai, Ayman Saeed, Muhammad Irfan Khan, Adrian Gran

Abstract

Background: 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.

Methods/design: 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 </= 20/40 in the study eye will be enrolled in this FILMS from eight sites across the UK and Ireland. Participants will be randomised to receive combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling. The primary outcome is distance visual acuity at 6 months. Secondary outcomes include distance visual acuity at 3 and 24 months, near visual acuity at 3, 6, and 24 months, contrast sensitivity at 6 months, reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3, 6, and 24 months), health related quality of life (HRQOL) at six months, costs to the health service and the participant, incremental costs per quality adjusted life year (QALY) and adverse events.

Discussion: FILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery.

Trial registration: This trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.

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