Differences in clinical outcomes in keratitis due to fungus and bacteria.

Methods | TheNational Eye Institute–funded Steroids for Corneal Ulcers Trial3,4 (SCUT) and the pilot study for the National Eye Institute–funded Mycotic Ulcer Treatment Trial2 (MUTT pilot) were concurrent, randomized controlled trials comparingoutcomes inpatientswithbacterial (SCUT)and fungal (MUTTpilot) keratitis. Detailedmethods have beenpreviously reported.2,3Outcomes for both trials includedbest spectacle-corrected visual acuity and infiltrate or scar size at 3 months fromenrollment, time to re-epithelialization, andcorneal perforation. The 2 trials were conducted at the Aravind Eye Care System (Madurai, Pondicherry, Tirunelveli, and Coimbatore, India) by the same investigators; allmeasurements were made by the same graders according to identical protocols. Patients were enrolled during overlapping periods (September 2006 throughFebruary 2010 for SCUT;December 2007 throughMay2008 forMUTTpilot). Institutional reviewboard approvalwasobtainedbytheUniversityofCalifornia,SanFrancisco Committee on Human Research and the Aravind Institutional ReviewBoard, andwritten informed consentwas obtained from each participant. All culture-positive bacterial and fungal cases enrolled in India were included in the analysis. Three-month best spectacle-corrected visual acuity and infiltrate or scar size between fungus and bacteria were analyzed by linear regression controlling for baseline characteristics (enrollment best spectacle-corrected visual acuity or infiltrate or scar size). In patients who had undergone corneal transplantation prior to their 3-month visit, last observation carried forward or an assignedvisual acuity of 1.7wasused,whicheverwasworse. For infiltrateor scar size, lastobservationcarried forwardwasused inthesepatients.Timetore-epithelializationwasanalyzedwith aCoxproportional hazardsmodel controlling for baseline epithelial defect size. Perforation was assessed using Fisher exact test.