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Randomized Controlled Trial
. 2010 Jun;128(6):672-8.
doi: 10.1001/archophthalmol.2010.102.

Comparison of natamycin and voriconazole for the treatment of fungal keratitis

Affiliations
Randomized Controlled Trial

Comparison of natamycin and voriconazole for the treatment of fungal keratitis

Namperumalsamy V Prajna et al. Arch Ophthalmol. 2010 Jun.

Abstract

Objective: To conduct a therapeutic exploratory clinical trial comparing clinical outcomes of treatment with topical natamycin vs topical voriconazole for fungal keratitis.

Methods: The multicenter, double-masked, clinical trial included 120 patients with fungal keratitis at Aravind Eye Hospital in India who were randomized to receive either topical natamycin or topical voriconazole and either had repeated scraping of the epithelium or not.

Main outcome measures: The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months. Other outcomes included scar size, perforations, and a subanalysis of BSCVA at 3 months in patients with an enrollment visual acuity of 20/40 to 20/400.

Results: Compared with those who received natamycin, voriconazole-treated patients had an approximately 1-line improvement in BSCVA at 3 months after adjusting for scraping in a multivariate regression model but the difference was not statistically significant (P = .29). Scar size at 3 months was slightly greater with voriconazole after adjusting for scraping (P = .48). Corneal perforations in the voriconazole group (10 of 60 patients) were not significantly different than in the natamycin-treated group (9 of 60 patients) (P >.99). Scraping was associated with worse BSCVA at 3 months after adjusting for drug (P = .06). Patients with baseline BSCVA of 20/40 to 20/400 showed a trend toward a 2-line improvement in visual acuity with voriconazole (P = .07).

Conclusions: Overall, there were no significant differences in visual acuity, scar size, and perforations between voriconazole- and natamycin-treated patients. There was a trend toward scraping being associated with worse outcomes. Application to Clinical Practice The benefit seen with voriconazole in the subgroup of patients with baseline visual acuity of 20/40 to 20/400 needs to be validated in a confirmatory clinical trial. Trial Registration clinicaltrials.gov Identifier: NCT00557362.

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Figures

Figure 1
Figure 1
Inclusion and exclusion criteria. All inclusion criteria must be met to participate in the study.
Figure 2
Figure 2
CONSORT flowchart. LOCF indicates last observation carried forward.
Figure 3
Figure 3
Relationship between baseline and 3-month best spectacle-corrected visual acuity (BSCVA).
Figure 4
Figure 4
Relationship between baseline and 3-month geometric mean infiltrate/scar size.

Comment in

  • Natamycin and voriconazole in fungal keratitis.
    Das M, Murthy SI, Dikshit S, Rathi V. Das M, et al. Arch Ophthalmol. 2011 Jun;129(6):814; author reply 814-5. doi: 10.1001/archophthalmol.2011.97. Arch Ophthalmol. 2011. PMID: 21670358 No abstract available.

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