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Effect of pretreatment with antifungal agents on clinical outcomes in fungal keratitis.

ABSTRACT: To determine if pretreatment with antifungal agents is predictive of worse clinical outcome in a fungal keratitis clinical trial.Non-pre-specified subgroup analysis of a randomized controlled trial in a tertiary hospital.Three hundred twenty-three fungal ulcer cases with an enrolment visual acuity of 20/40 to 20/400.The Mycotic Ulcer Treatment Trial I was a randomized, double-masked trial to determine the optimal treatment for filamentous fungal keratitis at the Aravind Eye Care System, India. Enrolled cases were randomized to receive topical natamycin or voriconazole. Prior antifungal medication use, dose and duration were collected at enrolment. A subgroup analysis was performed to determine if patients using natamycin or azoles at presentation have worse clinical outcomes compared with those who were not pretreated.Three-month visual acuity (primary), 3-month infiltrate or scar size, corneal perforation and/or transplant and re-epithelialization time.Of the 323 patients enrolled, 44% presented on an antifungal agent. Pretreated patients had larger mean baseline infiltrate size (P?

SUBMITTER: Sun CQ

PROVIDER: S-EPMC5177485 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Effect of pretreatment with antifungal agents on clinical outcomes in fungal keratitis.

Sun Catherine Q CQ Prajna N Venkatesh NV Krishnan Tiruvengada T Rajaraman Revathi R Srinivasan Muthiah M Raghavan Anita A O'Brien Kieran S KS McLeod Stephen D SD Acharya Nisha R NR Rose-Nussbaumer Jennifer J

Clinical & experimental ophthalmology 20160711 9

<h4>Background</h4>To determine if pretreatment with antifungal agents is predictive of worse clinical outcome in a fungal keratitis clinical trial.<h4>Design</h4>Non-pre-specified subgroup analysis of a randomized controlled trial in a tertiary hospital.<h4>Participants</h4>Three hundred twenty-three fungal ulcer cases with an enrolment visual acuity of 20/40 to 20/400.<h4>Methods</h4>The Mycotic Ulcer Treatment Trial I was a randomized, double-masked trial to determine the optimal treatment fo ...[more]

PMID: 27329780

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Project description:PurposeTo determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare natamycin versus amphotericin B for filamentous fungal keratitis.DesignOutcome-masked, 2×2 factorial design, randomized controlled clinical trial.ParticipantsConsecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India.MethodsStudy eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical natamycin 5% alone, (2) topical natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL.Main outcome measuresThe primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events.ResultsThose randomized to CXL regardless of medication (topical natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57-3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47-2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, -0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03-0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications.ConclusionsThere appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.

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Effect of pretreatment with antifungal agents on clinical outcomes in fungal keratitis.

Publications

Effect of pretreatment with antifungal agents on clinical outcomes in fungal keratitis.

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