Clinical and Cost-Effectiveness of Internal Limiting Membrane Peeling versus No Peeling for Patients With Idiopathic Full Thickness Macular Hole

Abstract

Purpose: : Internal limiting membrane (ILM) peeling has been used widely in combination with pars plana vitrectromy, detachment of the posterior hyaloid and gas in the management of patients with full-thickness macular hole (FTMH). The clinical and cost-effectiveness of this treatment, however, has not been addressed properly to date.

Methods: : Pragmatic, multicenter randomised controlled trial. Patients with idiopathic FTMH (stages 2 or 3) were randomised to receive ILM peeling or no peeling in a 1:1 ratio. The primary outcome was distance visual acuity (VA) at six months postoperatively. Secondary outcomes included distance VA at 3 months, near vision at 3 and 6 months, contrast sensitivity and reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3 and 6 months), patient reported outcomes at 6 months, complications, re-operation rates and cost-effectiveness.

Results: : Of the 141 patients randomised in 9 centres, 127 (90%) completed the six-month follow up. Non-statistically significant differences in distance VA (ETDRS) at six-months were found between groups (4.8 95% CI (-0.3, 9.8); p=0.063). However, there was a statistically significantly higher rate of macular hole closure in the ILM peel group at one month (p<0.001) with less re-operations performed by six months (OR: 0.25 95% CI (0.11, 0.54; p<0.001) when compared with no ILM peeling. The economic evaluation suggested that peeling the ILM is likely to be cost-effective.

Conclusions: : ILM peeling was superior to the no peel counterpart in the treatment of patients with idiopathic stage 2-3 FTMH.

Clinical Trial: : www.clinicaltrials.gov NCT00286507

Keywords: macular holes • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • vitreoretinal surgery