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

Noemi Lois, Jennifer Burr, John Norrie, Luke Vale, Jonathan Cook, Alison McDonald, Charles Boachie, Laura Ternent, Gladys McPherson, Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group, Gordon Murray

Research output: Contribution to journalArticlepeer-review

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)1586-92
Number of pages7
JournalInvestigative Ophthalmology & Visual Science
Volume52
Issue number3
DOIs
Publication statusPublished - Mar 2011

Keywords

  • Aged
  • Contrast Sensitivity
  • Cost of Illness
  • Cost-Benefit Analysis
  • Epiretinal Membrane
  • Female
  • Fluorescein Angiography
  • Fluorocarbons
  • Follow-Up Studies
  • Health Resources
  • Humans
  • Male
  • Phacoemulsification
  • Quality-Adjusted Life Years
  • Retinal Perforations
  • Tomography, Optical Coherence
  • Visual Acuity
  • Vitrectomy
  • Vitreoretinal Surgery

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