PURPOSE
To determine whether patients who had a positive repeated culture was predictive of worse clinical outcome than those who achieved microbiological cure at 6 days in the Mycotic Ulcer Treatment Trial I (MUTT-I).
DESIGN
Secondary analysis from a multicenter, double-masked, randomized clinical trial.
METHODS
Setting
Multiple hospital sites of the Aravind Eye Care System, India.
Study Population
Patients with culture-positive filamentous fungal ulcers and visual acuity of 20/40 to 20/400 re-examined 6 days after initiation of treatment
Intervention
Corneal scraping and cultures were obtained from study participants at day-6 after enrollment.
Main outcome Measures
We assess 3-month best spectacle corrected visual acuity (BSCVA), 3-month infiltrate/scar size, corneal perforation and re-epithelialization rates stratified by culture positivity at day 6.
RESULTS
Of the 323 patients with smear positive ulcers enrolled in MUTT-I, 299 (92.6%) were scraped and cultured six days after enrollment. Repeat culture positivity was 31% (92/299). Among patients who tested positive at enrollment, those with positive 6-day cultures had significantly worse 3-month BSCVA (0.39 LogMAR; 95% CI: 0.24 to 0.44; P<0.001), larger 3-month scar-size (0.39 mm; 95% CI: 0.06 to 0. 73; P=0.02), were more likely to perforate or require therapeutic penetrating keratoplasty (OR: 6.27; 95% CI: 2.73 to 14.40; P<0.001), and were slower to re-epithelialize (HR: 0.33; 95% CI: 0.21 to 0.50; P<0.001) than those with a negative 6-day culture result.
CONCLUSIONS
Early microbiological cure on culture is a predictor of clinical response to treatment.
TRIAL REGISTRATION clinicaltrials.gov Identifier
NCT00996736