title: Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole.
abstract: OBJECTIVE
  To assess the effect of an intravitreal ocriplasmin injection on visual function, measured using visual acuity (VA) and vision-related quality of life.
  
  
  METHODS
  Post hoc analysis of prespecified secondary end-points in two multicentre, randomized, double-masked, phase 3 clinical trials. A total of 652 participants with symptomatic vitreomacular adhesion were enrolled, of whom 464 received a single intravitreal injection of 125 μg ocriplasmin and 188 received a single intravitreal placebo injection. Based on principal components analysis results, visual function response (VFR) was defined as either a VA improvement of ≥2 lines; or an improvement in the composite score of the National Eye Institute Visual Function Questionnaire (VFQ-25) exceeding the minimal clinically important difference (MCID), estimated using the standard error of measurement approach; or an improvement in the VFQ-25 driving subscale score exceeding the MCID. The main outcome measure was VFR at 6 months.
  
  
  RESULTS
  A VFR occurred in 55.1% of the ocriplasmin group versus 34.2% of the placebo injection group (p < 0.0001). This comprised 23.7% versus 11.2% (p = 0.0003) with a ≥ 2-line VA improvement, 35.9% versus 22.7% (p = 0.0016) for the VFQ-25 composite score, and 10.2% versus 6.2% (p = 0.1697) for the driving subscale.
  
  
  CONCLUSIONS
  Ocriplasmin produces a clinically meaningful visual function benefit.
authors.affiliation: School of Medicine, King's College London, London, UK.
authors.forename: Timothy L
authors.identifier: http://orcid.org/0000-0001-7618-1555
authors.initials: TL
authors.lastname: Jackson
authors.affiliation: P95 Pharmacovigilance and Epidemiology Services, Leuven, Belgium.
authors.forename: Thomas
authors.initials: T
authors.lastname: Verstraeten
authors.affiliation: Ghent University, Ghent, Belgium.
authors.forename: Luc
authors.initials: L
authors.lastname: Duchateau
authors.affiliation: Xintera Ltd, Cambridge, UK.
authors.forename: Benedicte
authors.identifier: http://orcid.org/0000-0002-7976-0330
authors.initials: B
authors.lastname: Lescrauwaet
mesh_terms: D004311:Double-Blind Method; D005341:Fibrinolysin / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000187:drug effects* / Q000473:pathology; D010446:Peptide Fragments / Q000008:administration & dosage*; D011788:Quality of Life; D012167:Retinal Perforations / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires; D013997:Time Factors; D000267:Tissue Adhesions / Q000188:drug therapy / Q000473:pathology; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity; D014822:Vitreous Body / Q000187:drug effects* / Q000473:pathology
chemical_list: D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin
keywords: VFQ-25; macular hole; minimal clinically important difference; ocriplasmin; principal components analysis; symptomatic vitreomacular adhesion/vitreomacular traction