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Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole.
- Source :
-
Acta ophthalmologica [Acta Ophthalmol] 2017 Dec; Vol. 95 (8), pp. e740-e745. Date of Electronic Publication: 2017 Jan 30. - Publication Year :
- 2017
-
Abstract
- Purpose: To assess the effect of an intravitreal ocriplasmin injection on visual function, measured using visual acuity (VA) and vision-related quality of life.<br />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.<br />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.<br />Conclusion: Ocriplasmin produces a clinically meaningful visual function benefit.<br /> (© 2017 The Authors Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)
- Subjects :
- Double-Blind Method
Follow-Up Studies
Humans
Intravitreal Injections
Macula Lutea pathology
Retinal Perforations physiopathology
Surveys and Questionnaires
Time Factors
Tissue Adhesions drug therapy
Tissue Adhesions pathology
Tomography, Optical Coherence
Treatment Outcome
Vitreous Body pathology
Fibrinolysin administration & dosage
Macula Lutea drug effects
Peptide Fragments administration & dosage
Quality of Life
Retinal Perforations drug therapy
Visual Acuity
Vitreous Body drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1755-3768
- Volume :
- 95
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Acta ophthalmologica
- Publication Type :
- Academic Journal
- Accession number :
- 28133919
- Full Text :
- https://doi.org/10.1111/aos.13369