Lois, N., Burr, J., Norrie, J., Vale, L., Cook, J., McDonald, A., Boachie, C., Ternent, L. and McPherson, G. (2011) Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial. Investigative Ophthalmology and Visual Science, 52(3), pp. 1586-1592. (doi: 10.1167/iovs.10-6287)
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Abstract
<p>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).</p> <p>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.</p> <p>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.</p> <p>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.</p>
| Item Type: | Articles |
|---|---|
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Norrie, Prof John |
| Authors: | Lois, N., Burr, J., Norrie, J., Vale, L., Cook, J., McDonald, A., Boachie, C., Ternent, L., and McPherson, G. |
| Subjects: | R Medicine > R Medicine (General) |
| College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre |
| Journal Name: | Investigative Ophthalmology and Visual Science |
| ISSN: | 0146-0404 |
| ISSN (Online): | 1552-5783 |
| Published Online: | 04 November 2010 |
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