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Title: Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole : a pragmatic randomized controlled trial
Authors: Lois, Noemi
Burr, Jennifer Margaret
Norrie, John
Vale, Luke
Cook, Jonathan
McDonald, Alison
Boachie, Charles
Ternent, Laura
McPherson, Gladys
Full Thickness Macular Hole
Keywords: Clinical trial
Surgery
Vitrectomy
Removal
Stage-2
RE Ophthalmology
Issue Date: Mar-2011
Citation: Lois , N , Burr , J M , Norrie , J , Vale , L , Cook , J , McDonald , A , Boachie , C , Ternent , L , McPherson , G & Full Thickness Macular Hole 2011 , ' Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole : a pragmatic randomized controlled trial ' Investigative Ophthalmology & Visual Science , vol 52 , no. 3 , pp. 1586-1592 .
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 front 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. CONCLUSION. 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.) (Invest Ophthalmol Vis Sci 201152: 1586-1592) DOI:10.1167/iovs.10-6287
Version: Postprint
Status: Peer reviewed
URI: http://hdl.handle.net/2164/2054
http://hdl.handle.net/10023/2875
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://hdl.handle.net/2164/2054
http://aura.abdn.ac.uk/handle/2164/2645
DOI: http://dx.doi.org/10.1167/iovs.10-6287
ISSN: 0146-0404
Type: Journal article
Rights: Copyright © Association for Research in Vision and Ophthalmology. This is the author's version of this article.
Appears in Collections:University of St Andrews Research
Medicine Research



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