A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. The CSO funded FILMS trial has reported six month outcomes in a leading eye journal, Investigative Ophthalmology and Visual Science. This study was a randomised controlled trial recruiting 141 participants with macular hole (stages 2 and 3). The study investigated whether internal limiting membrane peeling compared with no peeling improved the success of macular hole surgery with regards to visual function, closure of the macular hole, quality of life and cost-effectiveness. The findings demonstrated no evidence of difference in distance visual acuity (primary outcome of the study) between ILM peel and no ILM peel groups at six months after macular hole surgery but initial ILM peeling was more likely to close the hole and reduce the need for further surgery. The study concluded that ILM peeling would seem the treatment of choice for idiopathic stage 2-3 FTMH and is likely to be a cost-effective use of resources.
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Lois N, Burr JM, Norrie J, Vale L, Cook J, McDonald A and the Full-thickness macular hole and Internal Limiting Membrane peeling Study (FILMS) Group. 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). Trials. 2008 Nov 3;9(1):61.
Lois N, Burr JM, Norrie J, Vale L, McDonald A, Boachie C, Ternent L, McPherson G for the Full-thickness macular hole and Internal Limiting Membrane peeling Study (FILMS) Group . Internal limiting membrane peeling versus no peeling for idiopathic full thickness macular hole: A pragmatic randomised controlled trial. Invest Ophthalmol Vis Sci 2011; 52(3) 1586-1592.
Ternent L, Vale L, Boachie C, Burr JM, Lois N; Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group. Cost-effectiveness of internal limiting membrane peeling versus no peeling for patients with an idiopathic full-thickness macular hole: results from a randomised controlled trial. Br J Ophthalmol. 2012 Mar;96(3):438-43.