Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: A pragmatic randomized controlled trial

Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group

Research output: Contribution to journalArticle

153 Citations (Scopus)
6 Downloads (Pure)

Abstract

Purpose. To determine whether internal limiting membrane (ILM) peeling is effective and cost effective compared with no peeling in patients with idiopathic stage 2 or 3 full-thickness maculay hole (FTMH).

Methods. This was a pragmatic multicenter randomized controlled trial. Eligible participants from nine centers were randomized to ILM peeling or no peeling (1:1 ratio) in addition to phacovitrectomy, including detachment and removal of the posterior hyaloid and gas tamponade. The primary outcome was distance visual acuity (VA) at 6 months after surgery. Secondary outcomes included hole closure, distance VA at other time points, near VA, contrast sensitivity, reading speed, reoperations, complications, resource use, and participant-reported health status, visual function, and costs.

Results. Of 141 participants randomized in nine centers, 127 (90%) completed the 6-month follow-up. Nonstatistically significant differences in distance visual acuity at 6 months were found between groups (mean difference, 4.8; 95% confidence interval [CI], −0.3 to 9.8; P = 0.063). There was a significantly higher rate of hole closure in the ILM-peel group (56 [84%] vs. 31 [48%]) at 1 month (odds ratio [OR], 6.23; 95% CI, 2.64–14.73; P < 0.001) with fewer reoperations (8 [12%] vs. 31 [48%]) performed by 6 months (OR, 0.14; 95% CI, 0.05–0.34; P < 0.001). Peeling the ILM is likely to be cost effective.

Conclusions. There was no evidence of a difference in distance VA after the ILM peeling and no-ILM peeling techniques. An important benefit in favor of no ILM peeling was ruled out. Given the higher anatomic closure and lower reoperation rates in the ILM-peel group, ILM peeling seems to be the treatment of choice for idiopathic stage 2 to 3 FTMH. (Clinical Trials.gov number, NCT00286507.)
Original languageEnglish
Pages (from-to)1586-1592
Number of pages7
JournalInvestigative Ophthalmology & Visual Science
Volume52
Issue number3
Early online date4 Nov 2010
DOIs
Publication statusPublished - 21 Mar 2011

Fingerprint Dive into the research topics of 'Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: A pragmatic randomized controlled trial'. Together they form a unique fingerprint.

  • Cite this