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Results of a Multicentered Randomized Clinical Trial

William R. Freeman, MD; Stanley P. Azen, PhD; Jung W. Kim, MD; Wael El-Haig, MD; Daniel R. Mishell III, MS; Ian Bailey, PhD; Vitrectomy for Treatment of Macular Hole Study Group

Arch Ophthalmol. 1997;115(1):11-21.

Abstract
Objective
To prospectively assess the risks and benefits of vitrectomy surgery for eyes with stage 3 or 4 macular holes.

Design
A multicentered, controlled, randomized clinical trial.

Setting
Community- and university-based ophthalmology clinics.

Patients
One hundred twenty patients (129 eyes) with stage 3 or 4 macular holes.

Interventions
Standardized macular hole surgery vs observation alone.

Main Outcome Measures
Four measures of bestcorrected visual function, standardized photographic evaluation of the extent of hole closure, evaluation of lens opacification, and determination of adverse events. Outcomes were determined at 6 months after randomization.

Results
Compared with observation alone, a significant benefit due to surgery was found in the rate of hole closure (4% vs 69%, P<.001). After adjusting for baseline visual acuity, hole duration, and maximum hole diameter, a significant benefit due to surgery was found in visual acuity for the Bailey-Lovie Word Reading (P=.02) and the Potential Acuity Meter (P<.01) tests; a marginally significant benefit due to surgery was found in visual acuity for the Early Treatment Diabetic Retinopathy Study chart (P=.05) Although the proportion of eyes achieving a change in visual acuity of 2 or more lines on the Early Treatment Diabetic Retinopathy Study chart was significantly greater for the surgery group vs the observed group (11 [19%] of 59 eyes vs 3[5%] of 58 eyes, adjusted P=.05), 20(34%) of 59 eyes randomized to surgery had a loss in visual acuity of 1 or more lines. Compared with the observation group, eyes randomized to surgery had higher nuclear sclerosis scores (2.4 vs 1.3, P<.001). Fourteen adverse events were noted in the surgery group; none were noted in the observed group.

Conclusions
Some visual benefit of vitrectomy surgery for macular holes exists, despite a notable incidence of adverse events. The large variability in visual acuity outcome in the surgical group may be because of complications or progressive cataract. A study of the longterm outcome after macular hole surgery is needed.

Author Affiliations
From the Department of Ophthalmology, Shiley Eye Center, University of California, San Diego (Drs Freeman, Kim, and El-Haig); the Statistical Consultation and Research Center, Department of Preventive Medicine, University of Southern California, Los Angeles (Dr Azen and Mr Mishell); and the School of Optometry, University of California, Berkeley (Dr Bailey). Dr Kim is now with the Department of Ophthalmology, Kangdong Sacred Heart Hospital, Hallym University, Seoul, Korea. Members of the Vitrectomy for Treatment of Macular Hole Study Group are listed in a box on page 20.

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