Recovery of Foveal Anatomy and Subfoveal Lucency after Pharmacologic and Surgical Macular Hole Closure in the Ocriplasmin Phase III Trials

Abstract

To compare foveal anatomic features on OCT after macular hole (MH) closure, and their association with visual function, in the ocriplasmin phase III trials. Randomized clinical trial. One hundred fifty-three participants. Each participant had 1 eye with baseline MH randomized to single intravitreal injection of placebo or ocriplasmin. After enrollment in 1 of the 2 nonsurgical treatment groups, a subset of eyes were analyzed in a surgical treatment group that had pars plana vitrectomy (PPV) after placebo or ocriplasmin. Subfoveal lucency after MH closure was graded on time-domain OCT (TD-OCT) at all visits, and was compared with visual acuity (VA) and fluorescein angiography (FA) leakage at the final study visit. In a subset of visits with spectral-domain OCT (SD-OCT), subfoveal lucency, ellipsoid zone (EZ), and external limiting membrane (ELM) defects were graded and measured. Eyes in the placebo, ocriplasmin, and PPV groups with MH closure 1 month after treatment had subfoveal lucency in 5 of 5 (100%), 42 of 43 (98%), and 8 of 37 (22%) eyes, respectively; and eyes with MH closure 6 months after treatment had subfoveal lucency in 3 of 8 (38%), 30 of 44 (68%), and 11 of 60 (18%) eyes, respectively. Resolution of subfoveal lucency lagged behind EZ and ELM recovery in the ocriplasmin group, whereas it preceded EZ and ELM recovery in the PPV group. Subfoveal lucency base width increased after MH closure with ocriplasmin (+662±139 μm) but decreased after placebo (-255±154 μm) and PPV (-777±243 μm), when compared with pretreatment MH base width. Subfoveal lucency was not associated with FA leakage or VA outcomes in any treatment group. After MH closure with ocriplasmin, subfoveal lucency width was greater than pretreatment MH and persisted longer during follow-up compared with placebo or PPV. Subfoveal lucency was not a marker for visual function regardless of treatment group.