Abstract
Purpose :
The MP-1 substudy of the larger OASIS trial evaluated the effects of ocriplasmin and vitreomacular traction (VMT)/symptomatic vitreomacular adhesion resolution on visual fixation and macular sensitivity using microperimetry.
Methods :
A total of 220 subjects were randomized into the OASIS study, from which 27 were enrolled into the MP-1 substudy (19 ocriplasmin, 8 sham). The substudy was conducted at 3 sites with protocol-specified microperimetry instruments. Fixation-related data included location, degree of eccentricity, and quantitative fixation stability (eg, bivariate contour ellipse area). Retinal sensitivity-related data included the number of normally functioning and scotomatous points and mean sensitivity within various macular grid regions.
Results :
Baseline (BL) characteristics of the MP-1 subset were largely similar to the OASIS study. The mean distance of the preferred fixation locus to the anatomic center decreased slightly after ocriplasmin injection from 1.32 degrees at BL to 1.11 degrees at Day (D) 7, returning to BL levels (1.28 degrees) by D28, compared to the sham group (1.19, 1.43, and 1.75 degrees at BL, D7, D28, respectively). This distance was identified as a predictor of VMT resolution (P=.023). In the ocriplasmin group, the median relative scotoma increased postinjection from 1.0 at BL to 6.0 at D7 before recovering to 1.0 at Month (M) 6, whereas more scotomas were detected in the sham group over time (3.5, 4.0, and 5.0 at BL, D7, and M6, respectively). Mean bivariate contour ellipse area decreased slightly after ocriplasmin injection, from 5.98 degrees squared at BL to 4.26 degrees squared at D7 and 5.38 degrees squared at D28, compared to sham (7.73, 7.41, and 8.85 degrees squared at BL, D7, and D28, respectively). Subjects with VMT resolution at D28 had lower bivariate contour area and less relative scotoma at BL than those without. Of the visual function parameters, correlations were strongest for contrast sensitivity followed by best-corrected visual acuity, with no anatomical correlations.
Conclusions :
Despite the small sample size, the MP-1 substudy suggests that in the ocriplasmin group, fixation and sensitivity parameters tended to be better than in the sham group over time. Although sensitivity seemed to decrease from D7 to D28 (with more relative scotomatous points) in the ocriplasmin group, it recovered subsequently.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.