Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole: The OASIS study

Benedicte Lescrauwaet*, Luc Duchateau, Thomas Verstraeten, Timothy L. Jackson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)
147 Downloads (Pure)

Abstract

Purpose: To assess the effect of ocriplasmin on visual function response (VFR) measured using visual acuity (VA) and vision-related quality of life, and to quantify the association between release of vitreomacular adhesion (VMA) at day 28 and VFR.

Methods: Prespecified analysis of secondary endpoints from a randomized controlled trial. Of 220 participants with symptomatic VMA/vitreomacular traction (VMT), including VMT associated with a macular hole up to 400 μm, 146 received a single intravitreal injection of 125 μg ocriplasmin and 74 a sham injection. Based on principal components analysis results, a VFR was defined as either a VA improvement of ≥2 lines or an improvement exceeding the minimal clinically important difference (MCID) in the composite or the mental health subscale scores of the Visual Function Questionnaire (VFQ-25). The MCID was estimated using the standard error of measurement approach. The main outcome measure was the VFR at month 6, with further assessments at months 12 and 24.

Results: The MCID was estimated at 3.71 points for the VFQ-25 composite score and 10.71 for the VFQ-25 mental health subscale score. A VFR occurred in 51.0% of ocriplasmin versus 23.3% of sham participants (P = 0.0001). The VFR was maintained through months 12 and 24: 53.1% and 50.3% in ocriplasmin versus 21.9% and 20.5% in sham participants, respectively (P < 0.0001). Resolution of VMA at day 28 significantly increased the odds of a VFR at each assessment period.

Conclusions: Treatment with ocriplasmin compared with sham resulted in a significant improvement in VFR. The 6-month treatment effect was sustained at months 12 and 24.

Original languageEnglish
Pages (from-to)5842-5848
Number of pages7
JournalInvestigative Ophthalmology & Visual Science
Volume58
Issue number13
DOIs
Publication statusPublished - Nov 2017

Keywords

  • Macular hole
  • Minimal clinically important difference
  • Ocriplasmin
  • Patient-reported outcomes
  • Principal components analysis
  • Sham
  • Symptomatic vitreomacular adhesion/vitreomacular traction
  • VFQ-25

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