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Clinical pilot study to evaluate the efficacy of a preservative-free hypertonic ophthalmic solution for patients with symptomatic corneal edema

Journal francais d'ophtalmologie, 2015-11, Vol.38 (9), p.800-808 [Peer Reviewed Journal]

Copyright © 2015 Elsevier Masson SAS. All rights reserved. ;Distributed under a Creative Commons Attribution 4.0 International License ;ISSN: 0181-5512 ;EISSN: 1773-0597 ;DOI: 10.1016/j.jfo.2015.04.011 ;PMID: 26443383

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  • Title:
    Clinical pilot study to evaluate the efficacy of a preservative-free hypertonic ophthalmic solution for patients with symptomatic corneal edema
  • Author: Rouland, J-F
  • Subjects: Aged ; Aged, 80 and over ; Cognitive science ; Cornea - pathology ; Corneal Edema - diagnosis ; Corneal Edema - drug therapy ; Female ; Humans ; Male ; Middle Aged ; Ophthalmic Solutions - therapeutic use ; Pilot Projects ; Preservatives, Pharmaceutical ; Saline Solution, Hypertonic - therapeutic use ; Time Factors ; Treatment Outcome ; Visual Acuity
  • Is Part Of: Journal francais d'ophtalmologie, 2015-11, Vol.38 (9), p.800-808
  • Description: This exploratory clinical trial aims to assess the effect on visual acuity and central corneal thickness of an unpreserved hypertonic ophthalmic solution containing sodium chloride (5%) and sodium hyaluronate, in patients with chronic corneal edema caused by endothelial disease reducing their visual acuity. Twenty patients were enrolled and treated with the hypertonic solution (1 to 2 drops per eye, 4 times a day over 28 days). Progression of visual acuity (ETDRS score) and corneal thickness (ultrasonic pachymetry) was measured from baseline (without treatment) through the treatment period (Day 7 and Day 28). The analyses were performed on 18 patients (Full Analysis Set [FAS] population). The causes of corneal edema were Fuchs endothelial dystrophy in 10 cases and post-cataract surgery endothelial decompensation in 8 patients. The mean visual acuity values for the FAS population compared between baseline (Day-7) and one week of treatment (Day+7) show a significant 5-point VA improvement (P<0.001 paired Wilcoxon test). For corneal thickness, there was also a significant decrease (P=0.033 paired Wilcoxon test). Functional improvement was observed at 28 days of instillation. No adverse events were recorded during the clinical study. In conclusion, the unpreserved hyperosmolar solution containing sodium chloride and sodium hyaluronate significantly improved ETDRS visual acuity after one week of use. In this clinical trial, the solution also showed excellent tolerability results.
  • Publisher: France: Elsevier Masson
  • Language: French;English
  • Identifier: ISSN: 0181-5512
    EISSN: 1773-0597
    DOI: 10.1016/j.jfo.2015.04.011
    PMID: 26443383
  • Source: MEDLINE
    Alma/SFX Local Collection
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