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Eric W. Schneider, Cynthia A Toth, Glenn J Jaffe; Baseline Characteristics of Vitreomacular Traction Progressing to Full-Thickness Macular or Lamellar Holes in the Phase III Trials of Enzymatic Vitreolysis. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1216.
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© ARVO (1962-2015); The Authors (2016-present)
To identify characteristics associated with progression from vitreomacular traction (VMT) to a full-thickness macular hole (FTMH) or lamellar hole (LH) following a single intravitreal injection of saline or ocriplasmin.
A post-hoc analysis was performed on 445 eyes with baseline VMT included in a phase III trial evaluating ocriplasmin for symptomatic vitreomacular adhesion (MIVI-TRUST). Exact logistic regression analyses were used to identify baseline characteristics significantly associated with progression from VMT to FTMH or LH over the 6-month study period. Kaplan-Meier survival analysis was performed to compare time to FTMH or LH development between treatment groups. OCT images were graded independently by two certified readers at the Duke OCT Reading Center.
Twenty eyes (4.5%) developed a FTMH and 38 (9.7%) developed a LH during the study period. The rate of progression to FTMH or LH did not differ significantly between ocriplasmin- and saline-treated eyes (p=0.125 for FTMH, p=0.348 for LH). Mean time to FTMH and LH development was similar in ocriplasmin- (176.0 days [d] for FTMH, 168.8d for LH) and saline-treated (172.4d for FTMH, 164.7d for LH) (p=0.090 for FTMH, p=0.369 for LH). On univariate analysis, the presence of subretinal fluid (SRF) (adjusted odds ratio [AOR] 5.64, 95% confidence interval [CI] 2.02-17.17, p < 0.001) and mean SRF thickness (AOR 1.10, 95% CI 1.04-1.16, p=0.003) were associated with FTMH development. Both remained significantly associated with FTMH development on multivariate testing. On univariate analysis, the presence of macular schisis (AOR 2.26, 95% CI 1.39-3.82, p=0.004) and mean retinal thickness (AOR 1.06, 95% CI 1.01-1.10, p=0.010) were associated with LH development. There was a trend towards increased progression to LH with baseline intraretinal cysts (AOR 2.62, 95% CI 0.924-8.747, p=0.076) that did not reach significance. Schisis remained a significant predictor of LH formation on multivariate testing.
VMT, when associated with SRF, is more likely to progress to FTMH while, when associated with intraretinal changes (such as schisis), appears more likely to progress to a LH. These findings suggest a disparate natural history for VMT based on the level of retinal dehiscence (intra- versus subretinal) and argues for continued use of the stage 1 FTMH classification.
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