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Adjunctive Oral Voriconazole Treatment of Fusarium Keratitis: A Secondary Analysis From the Mycotic Ulcer Treatment Trial II.
- Source :
-
JAMA ophthalmology [JAMA Ophthalmol] 2017 Jun 01; Vol. 135 (6), pp. 520-525. - Publication Year :
- 2017
-
Abstract
- Importance: Fusarium keratitis is common and often results in poor outcomes. No new treatments since natamycin have become available.<br />Objective: To explore the role of adjuvant oral voriconazole on clinical outcomes in Fusarium keratitis.<br />Design, Setting, and Participants: In this prespecified subgroup analysis of a multicenter, double-masked, placebo-controlled randomized clinical trial, 240 patients from the Aravind Eye Care System in India, the Lumbini Eye Hospital and Bharatpur Eye Hospital in Nepal, and the University of California, San Francisco, who had culture-positive fungal ulcer and baseline visual acuity of 20/400 or worse were randomized to receive oral voriconazole vs placebo. Enrollment started May 24, 2010, and the last patient study visit was November 23, 2015. All patients received topical voriconazole, 1%, and after the results of the Mycotic Ulcer Treatment Trial (MUTT) II became available, topical natamycin, 5%, was added for all patients. Data analysis was performed from September 2 to October 28, 2016.<br />Main Outcomes and Measures: The primary outcome of the trial was the rate of corneal perforation or the need for therapeutic penetrating keratoplasty. Secondary outcomes included rate of reepithelialization, best spectacle-corrected visual acuity, and infiltrate or scar size at 3 months.<br />Results: Of the 240 study participants, 72 (30.4%) were culture positive for Fusarium species (41 [56.9%] male and 31 [43.1%] female; median [interquartile range] age, 50 [45-57] years). Of these, 33 (45.8%) were randomized to oral voriconazole and 39 (54.2%) to placebo. Fusarium ulcers randomized to oral voriconazole had a 0.43-fold decreased hazard of perforation or therapeutic penetrating keratoplasty compared with placebo after controlling for baseline infiltrate depth (95% CI, 0.22-fold to 0.84-fold; P = .01). Multiple linear regression revealed a 1.89-mm decreased infiltrate and/or scar size at 3 weeks (95% CI, -2.69 to -1.09 mm; P < .001) and a 0.83-mm decreased infiltrate and/or scar size at 3 months after correcting for baseline values (95% CI, -1.33 to -0.32 mm; P = .001) in eyes randomized to oral voriconazole vs placebo. Eyes treated with oral voriconazole also had a mean 0.29 decreased logMAR (improved) (Snellen equivalent 20/40) visual acuity at 3 months after controlling for baseline visual acuity, although this finding was not statistically significant (95% CI, -0.57 to 0.002; P = .052).<br />Conclusions and Relevance: Although MUTT II could not find a benefit for all corneal ulcers, Fusarium keratitis may benefit from the addition of oral voriconazole to topical natamycin, and physicians should consider prescribing oral voriconazole in these cases.<br />Trial Registration: clinicaltrials.gov Identifier: NCT00996736.
- Subjects :
- Administration, Oral
Antifungal Agents administration & dosage
Cornea microbiology
Corneal Ulcer diagnosis
Corneal Ulcer microbiology
Dose-Response Relationship, Drug
Double-Blind Method
Eye Infections, Fungal diagnosis
Eye Infections, Fungal microbiology
Female
Follow-Up Studies
Fusariosis diagnosis
Fusariosis microbiology
Humans
Keratitis diagnosis
Keratitis microbiology
Male
Middle Aged
Retrospective Studies
Treatment Outcome
Corneal Ulcer drug therapy
Eye Infections, Fungal drug therapy
Fusariosis drug therapy
Fusarium isolation & purification
Keratitis drug therapy
Visual Acuity
Voriconazole administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2168-6173
- Volume :
- 135
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- JAMA ophthalmology
- Publication Type :
- Academic Journal
- Accession number :
- 28426856
- Full Text :
- https://doi.org/10.1001/jamaophthalmol.2017.0616