Objective: To study complications of vitrectomy surgery for full-thick
ness macular holes. Design: A multicentered, randomized, controlled cl
inical trial. Participants: Community and university-based ophthalmolo
gy clinics. Intervention: Standardized macular hole surgery versus obs
ervation. Main Outcome Measures: Assessment of anatomic and visual out
comes and determination of postoperative complications at 12 months af
ter randomization. Results: Posterior segment complications were noted
in 39 eyes (41%). The incidences of retinal pigment: epithelium (RPE)
alteration and retinal detachment (RD) were 33% and 11%, respectively
. One RD due to a giant retinal tear resulted in a visual acuity of li
ght perception. Other complications included a reopening of the macula
r hole in 2 eyes (2%), cystoid macular edema in 1 eye (1%), a choroida
l neovascular membrane in 1 eye (1%), and endophthalmitis in 1 eye (1%
). Eyes with complications had significantly worse visual acuity outco
mes as determined by the Early Treatment Diabetic Retinopathy Study, W
ord Reading, and Potential Acuity Meter charts (P < 0.01 for all compa
risons). Eyes with macular holes greater than 475 mu m were more than
twice as likely to have complications than eyes with holes less than 4
75 mu m (odds ratio [OR] = 2.2, P = 0.07). Before surgery, the stage o
f the hole was related to postoperative RPE changes (P < 0.0001) and t
he occurrence of postoperative RD (P = 0.0002). Intraoperative trauma
was related to the occurrence of these complications (P < 0.0001 for R
PE changes, P = 0.02 for RDs). Epiretinal membrane removal was related
to RPE changes (P = 0.02) but not RDs. Conclusions: The RPE alteratio
ns and RDs are common after macular hole surgery and result in signifi
cantly reduced postoperative visual acuity. The RPE changes may be rel
ated to surgical trauma or light toxicity, Further efforts to reduce c
omplications associated with macular hole surgery are indicated.