PMID- 28133919
OWN - NLM
STAT- MEDLINE
DCOM- 20180102
LR  - 20220408
IS  - 1755-3768 (Electronic)
IS  - 1755-375X (Print)
IS  - 1755-375X (Linking)
VI  - 95
IP  - 8
DP  - 2017 Dec
TI  - Visual function response to ocriplasmin for the treatment of vitreomacular 
      traction and macular hole.
PG  - e740-e745
LID - 10.1111/aos.13369 [doi]
AB  - PURPOSE: 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 mug 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. CONCLUSION: Ocriplasmin produces a 
      clinically meaningful visual function benefit.
CI  - (c) 2017 The Authors Acta Ophthalmologica published by John Wiley & Sons Ltd on 
      behalf of Acta Ophthalmologica Scandinavica Foundation.
FAU - Jackson, Timothy L
AU  - Jackson TL
AUID- ORCID: 0000-0001-7618-1555
AD  - School of Medicine, King's College London, London, UK.
FAU - Verstraeten, Thomas
AU  - Verstraeten T
AD  - P95 Pharmacovigilance and Epidemiology Services, Leuven, Belgium.
FAU - Duchateau, Luc
AU  - Duchateau L
AD  - Ghent University, Ghent, Belgium.
FAU - Lescrauwaet, Benedicte
AU  - Lescrauwaet B
AUID- ORCID: 0000-0002-7976-0330
AD  - Xintera Ltd, Cambridge, UK.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170130
PL  - England
TA  - Acta Ophthalmol
JT  - Acta ophthalmologica
JID - 101468102
RN  - 0 (Peptide Fragments)
RN  - 7V6HE3DM5A (microplasmin)
RN  - EC 3.4.21.7 (Fibrinolysin)
SB  - IM
MH  - Double-Blind Method
MH  - Fibrinolysin/*administration & dosage
MH  - Follow-Up Studies
MH  - Humans
MH  - Intravitreal Injections
MH  - Macula Lutea/*drug effects/pathology
MH  - Peptide Fragments/*administration & dosage
MH  - *Quality of Life
MH  - Retinal Perforations/*drug therapy/physiopathology
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Tissue Adhesions/drug therapy/pathology
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
MH  - *Visual Acuity
MH  - Vitreous Body/*drug effects/pathology
PMC - PMC5901404
OTO - NOTNLM
OT  - VFQ-25
OT  - macular hole
OT  - minimal clinically important difference
OT  - ocriplasmin
OT  - principal components analysis
OT  - symptomatic vitreomacular adhesion/vitreomacular traction
EDAT- 2017/01/31 06:00
MHDA- 2018/01/03 06:00
PMCR- 2018/04/16
CRDT- 2017/01/31 06:00
PHST- 2016/07/20 00:00 [received]
PHST- 2016/11/18 00:00 [accepted]
PHST- 2017/01/31 06:00 [pubmed]
PHST- 2018/01/03 06:00 [medline]
PHST- 2017/01/31 06:00 [entrez]
PHST- 2018/04/16 00:00 [pmc-release]
AID - AOS13369 [pii]
AID - 10.1111/aos.13369 [doi]
PST - ppublish
SO  - Acta Ophthalmol. 2017 Dec;95(8):e740-e745. doi: 10.1111/aos.13369. Epub 2017 Jan 
      30.