PMID- 29141079
OWN - NLM
STAT- MEDLINE
DCOM- 20171127
LR  - 20220408
IS  - 1552-5783 (Electronic)
IS  - 0146-0404 (Linking)
VI  - 58
IP  - 13
DP  - 2017 Nov 1
TI  - Visual Function Response to Ocriplasmin for the Treatment of Vitreomacular 
      Traction and Macular Hole: The OASIS Study.
PG  - 5842-5848
LID - 10.1167/iovs.17-22363 [doi]
AB  - 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 mum, 146 received a single intravitreal injection of 125 mug 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.
FAU - Lescrauwaet, Benedicte
AU  - Lescrauwaet B
AD  - Xintera Ltd, Cambridge, United Kingdom.
FAU - Duchateau, Luc
AU  - Duchateau L
AD  - Ghent University, Ghent, Belgium.
FAU - Verstraeten, Thomas
AU  - Verstraeten T
AD  - P95 Pharmacovigilance and Epidemiology Services, Leuven, Belgium.
FAU - Jackson, Timothy L
AU  - Jackson TL
AD  - School of Medicine, King's College London, London, United Kingdom.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Invest Ophthalmol Vis Sci
JT  - Investigative ophthalmology & visual science
JID - 7703701
RN  - 0 (Fibrinolytic Agents)
RN  - 0 (Peptide Fragments)
RN  - 7V6HE3DM5A (microplasmin)
RN  - EC 3.4.21.7 (Fibrinolysin)
SB  - IM
MH  - Double-Blind Method
MH  - Female
MH  - Fibrinolysin/*therapeutic use
MH  - Fibrinolytic Agents/*therapeutic use
MH  - Humans
MH  - Intravitreal Injections
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/*therapeutic use
MH  - *Quality of Life
MH  - Retinal Diseases/*drug therapy/physiopathology
MH  - Retinal Perforations/*drug therapy/physiopathology
MH  - Sickness Impact Profile
MH  - Tissue Adhesions
MH  - Visual Acuity/*physiology
MH  - Vitreous Body/*drug effects/physiopathology
EDAT- 2017/11/16 06:00
MHDA- 2017/11/29 06:00
CRDT- 2017/11/16 06:00
PHST- 2017/11/16 06:00 [entrez]
PHST- 2017/11/16 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
AID - 2663997 [pii]
AID - 10.1167/iovs.17-22363 [doi]
PST - ppublish
SO  - Invest Ophthalmol Vis Sci. 2017 Nov 1;58(13):5842-5848. doi: 
      10.1167/iovs.17-22363.