Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial.
OBJECTIVE
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.).
Ophthalmology Department, Grampian University Hospitals-NHS (National Health Service) Trust, Aberdeen, United Kingdom. noemilois@aol.com
Noemi
N
Lois
Jennifer
J
Burr
John
J
Norrie
Luke
L
Vale
Jonathan
J
Cook
Alison
A
McDonald
Charles
C
Boachie
Laura
L
Ternent
Gladys
G
McPherson
D000368:Aged; D015350:Contrast Sensitivity / Q000502:physiology; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D019773:Epiretinal Membrane / Q000191:economics / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005451:Fluorescein Angiography; D005466:Fluorocarbons / Q000008:administration & dosage; D005500:Follow-Up Studies; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D018918:Phacoemulsification; D019057:Quality-Adjusted Life Years; D012167:Retinal Perforations / Q000191:economics / Q000503:physiopathology / Q000601:surgery*; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology; D014821:Vitrectomy; D057586:Vitreoretinal Surgery
D005466:Fluorocarbons; C042852:perflutren