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

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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

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Retinal Perforations
Randomized Controlled Trials
Membranes
Visual Acuity
Reoperation
Confidence Intervals
Costs and Cost Analysis
Odds Ratio
Contrast Sensitivity
Health Status
Reading
Gases
Clinical Trials

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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.

In: Investigative Ophthalmology & Visual Science, Vol. 52, No. 3, 21.03.2011, p. 1586-1592.

Research output: Contribution to journalArticle

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 randomized controlled trial. In: Investigative Ophthalmology & Visual Science. 2011 ; Vol. 52, No. 3. pp. 1586-1592.
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title = "Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: A pragmatic randomized controlled trial",
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.)",
author = "Noemi Lois and Jennifer Burr and John Norrie and Luke Vale and Jonathan Cook and Alison McDonald and Charles Boachie and Laura Ternent and Gladys McPherson and {Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group}",
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AU - Lois, Noemi

AU - Burr, Jennifer

AU - Norrie, John

AU - Vale, Luke

AU - Cook, Jonathan

AU - McDonald, Alison

AU - Boachie, Charles

AU - Ternent, Laura

AU - McPherson, Gladys

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

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N2 - 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.)

AB - 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.)

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DO - 10.1167/iovs.10-6287

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VL - 52

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EP - 1592

JO - Investigative Ophthalmology & Visual Science

JF - Investigative Ophthalmology & Visual Science

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