Jw. Kim et al., PROSPECTIVE RANDOMIZED TRIAL OF VITRECTOMY OR OBSERVATION FOR STAGE-2MACULAR HOLES, American journal of ophthalmology, 121(6), 1996, pp. 605-614
PURPOSE: To determine the risks and benefits of vitrectomy surgery in
eyes with stage 2 macular holes, METHODS: A multicentered, controlled,
randomized clinical trial was performed with participation of 16 comm
unity and university-based ophthalmology clinics, Thirty-six eyes with
stage 2 macular holes and 12 months of follow-up were studied, Pars p
lana vitrectomy with separation of the posterior hyaloid membrane and
intraocular injection of perfluoropropane (C3F8) was followed by posto
perative face down positioning for two weeks, This protocol was compar
ed with observation alone, Outcome variables included anatomic closure
of the macular hole, macular hole size, and four standardized measure
s of vision, RESULTS: At 12 months, 15 (71%) of 21 eyes randomly assig
ned to observation progressed to stages 3 or 4, compared with three (2
0%) of 15 eyes randomly assigned to surgery (P < .006), Compared with
eyes randomly assigned to observation, eyes randomly assigned to surge
ry had significantly smaller hole diameters (P < .01) and significantl
y better visual acuity outcomes, as measured by the Word Reading (P =
.02) and Potential Acuity Meter (P = .002) charts, No significant diff
erences were found for the Early Treatment Diabetic Retinopathy Study
chart and Contrast Sensitivity test. CONCLUSION: Compared with observa
tion alone, surgical intervention in stage 2 macular holes resulted in
a significantly lower incidence of hole enlargement and appeared to b
e associated with better outcome in some measures of visual acuity.