title: Topical 5% Natamycin With Oral Ketoconazole in Filamentous Fungal Keratitis: A Randomized Controlled Trial.
abstract: OBJECTIVE
  To assess the role of additive oral antifungal therapy in deep keratitis caused by filamentous fungi.
  
  
  METHODS
  A randomized, masked, double-blind clinical trial.
  
  
  METHODS
  All patients presenting with culture-positive fungal keratitis with a size measuring 2 to 60 mm2 and involving more than 50% of stromal depth were enrolled in 1 of the 2 treatment arms. Group A received 5% natamycin, whereas Group B was given 200mg of oral ketoconazole twice a day in addition to 5% natamycin. Patients were followed up for 4 weeks. Liver function was assessed at baseline and at exit. Tests for significance included t test to compare the means of continuous variables, chi-square and Fisher's exact tests for comparing categorical variables and Kaplan-Meier procedure to estimate the survival rate.
  
  
  RESULTS
  Of the 115 patients enrolled, 108 completed the study. Fifty-eight patients were in group A and 57 in group B. There was no significant difference in baseline characteristics or in ulcer characteristics between the 2 groups. In group A, 68.5% of the patients responded favorably to medical therapy, whereas in group B, 72.2% responded favorably. There was no statistically significant difference in healing between the 2 groups (P = -0.618). All patients had normal liver functions during the study.
  
  
  CONCLUSIONS
  Although safe, oral ketoconazole did not add significant benefit to topical natamycin therapy in treating deep fungal keratitis. The efficacy of newer antifungal agents and drug delivery routes needs to be explored.
authors.affiliation: From the *Department of Cornea and Refractive Services, Aravind Eye Hospital, Coimbatore; and †Department of Cornea and Refractive Services, Aravind Eye Hospital, Madurai, Tamil Nadu, India.
authors.forename: Revathi
authors.initials: R
authors.lastname: Rajaraman
authors.forename: Parameshwar
authors.initials: P
authors.lastname: Bhat
authors.forename: Vikram
authors.initials: V
authors.lastname: Vaidee
authors.forename: Sowmyalatha
authors.initials: S
authors.lastname: Maskibail
authors.forename: Anita
authors.initials: A
authors.lastname: Raghavan
authors.forename: Siddharthan
authors.initials: S
authors.lastname: Sivasubramaniam
authors.forename: Venkatesh Prajna
authors.initials: VP
authors.lastname: Namperumalsamy
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015821:Eye Infections, Fungal / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007634:Keratitis / Q000188:drug therapy*; D007654:Ketoconazole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010866:Natamycin / Q000008:administration & dosage*; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D009883:Ophthalmic Solutions; D010866:Natamycin; D007654:Ketoconazole