Complications of intravitreal ocriplasmin for vitreomacular traction and macular hole: a prospective spectral-domain optical coherence tomography study

Abstract

Objective: The purpose of this study was to evaluate the safety of intravitreal ocriplasmin prospectively, reporting potential complications in patients with vitreomacular traction (VMT) alone or associated with macular hole (MH).Materials and methods: Participants in this prospective, multicenter study, were 24 patients with VMT (17 with VMT alone and seven with MH combined with VMT). All patients were treated with a single ocriplasmin injection and followed-up prospectively at baseline, day 7, 28 and the last examination of the follow-up for each patient (mean ± SD: 64.2 ± 24.4 d, range: 40–145 d). Best-corrected visual acuity (BCVA) was assessed, and spectral-domain optical coherence tomography was performed at each visit while the percentage of resolution of VMT and the association with various potential adverse events were recorded and analyzed.Results: 66.7% of patients presented VMT release at the end of the follow-up, while 28.6% exhibited MH closure. Severe adverse events, such as enlargement of preexisting MH and formation of lamellar MH, were observed in one and four cases, respectively and remained till the end of the follow-up. Moderate adverse events, such as ellipsoid zone disruption and subretinal fluid development, became evident seven days after injection, in four cases. Formation of cystoid macular edema (CME), not evident at baseline, was noticed in three cases at day 28 after injection. Mild adverse events, like vitreous floaters, photopsias, eye pain and foreign body sensation, were noticed at day 7 and resolved till the end of the follow-up.Conclusions: Mild and moderate adverse events occurred mainly during the first week of the follow-up, while severe adverse events, such as the lamellar MH formation and CME at day 28 post injection were seen.