Kathryn J Ray1, Prajna Lalitha2, N Venkatesh Prajna2, Revathi Rajaraman2, Tiruvengada Krishnan2, Muthiah Srinivasan2, Peter Ryg3, Stephen McLeod4, Nisha R Acharya4, Thomas M Lietman5, Jennifer Rose-Nussbaumer6. 1. Francis I. Proctor Foundation, San Francisco, California. 2. Aravind Eye Care System, Madurai, Pondicherry, and Coimbatore, India. 3. Department of Ophthalmology, University of California San Francisco, San Francisco, California. 4. Francis I. Proctor Foundation, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California. 5. Francis I. Proctor Foundation, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California. 6. Francis I. Proctor Foundation, San Francisco, California; Department of Ophthalmology, University of California San Francisco, San Francisco, California. Electronic address: Jennifer.Rose@ucsf.edu.
Abstract
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 reexamined 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 assessed 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 6 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% confidence interval [CI]: 0.24-0.44; P < .001), had larger 3-month scar size (0.39 mm; 95% CI: 0.06-0.73; P = .02), were more likely to perforate or require therapeutic penetrating keratoplasty (odds ratio: 6.27; 95% CI: 2.73-14.40; P < .001), and were slower to re-epithelialize (hazard ratio: 0.33; 95% CI: 0.21-0.50; P < .001) than those with a negative 6-day culture result. CONCLUSIONS: Early microbiological cure on culture is a predictor of clinical response to treatment.
RCT Entities:
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 reexamined 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 assessed 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 6 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% confidence interval [CI]: 0.24-0.44; P < .001), had larger 3-month scar size (0.39 mm; 95% CI: 0.06-0.73; P = .02), were more likely to perforate or require therapeutic penetrating keratoplasty (odds ratio: 6.27; 95% CI: 2.73-14.40; P < .001), and were slower to re-epithelialize (hazard ratio: 0.33; 95% CI: 0.21-0.50; P < .001) than those with a negative 6-day culture result. CONCLUSIONS: Early microbiological cure on culture is a predictor of clinical response to treatment.
Authors: Prajna Lalitha; Muthiah Srinivasan; P Manikandan; M Jayahar Bharathi; Revathi Rajaraman; Meenakshi Ravindran; Vicky Cevallos; Catherine E Oldenburg; Kathryn J Ray; Christine M Toutain-Kidd; David V Glidden; Michael E Zegans; Stephen D McLeod; Nisha R Acharya; Thomas M Lietman Journal: Clin Infect Dis Date: 2012-03-23 Impact factor: 9.079
Authors: V G De Gruttola; P Clax; D L DeMets; G J Downing; S S Ellenberg; L Friedman; M H Gail; R Prentice; J Wittes; S L Zeger Journal: Control Clin Trials Date: 2001-10
Authors: N Venkatesh Prajna; Naveen Radhakrishnan; Prajna Lalitha; Ariana Austin; Kathryn J Ray; Jeremy D Keenan; Travis C Porco; Thomas M Lietman; Jennifer Rose-Nussbaumer Journal: Ophthalmology Date: 2019-09-04 Impact factor: 12.079
Authors: Kathryn J Ray; N Venkatesh Prajna; Prajna Lalitha; Revathi Rajaraman; Tiruvengada Krishnan; Sushila Patel; Manoranjan Das; Ranjeet Shah; Kavita Dhakhwa; Stephen D McLeod; Michael E Zegans; Nisha R Acharya; Thomas M Lietman; Jennifer Rose-Nussbaumer Journal: Am J Ophthalmol Date: 2018-02-10 Impact factor: 5.258
Authors: Naveen Radhakrishnan; Venkatesh N Prajna; Lalitha S Prajna; Anitha Venugopal; Shivanandha Narayana; Revathi Rajaraman; Guillermo Amescua; Travis C Porco; Thomas M Lietman; Jennifer Rose-Nussbaumer Journal: BMJ Open Ophthalmol Date: 2021-11-29