Abstract
Purpose :
To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and 1% Voriconazole in patients affected by fungal keratitis in a randomized masked double blind control trial.
Methods :
This Institute review board approved prospective double masked randomized clinical trial included patients with smear or culture proven fungal keratitis. Patients not willing to give consent, unable to cooperate, bacterial, parasitic or viral infection or co-infection, impending or actual perforation, bilateral or scleral involvement, previous ocular surgery, corneal scar, known allergy to study medication (drug or preservative), pregnant or nursing females, and immunocompromised patients were excluded.
Group A was started on 5% Natamycin and 1% Voriconazole hourly. Group B was started on 5% Natamycin and placebo (Voriconazole vehicle) one hourly.
The primary outcome measure was complete resolution of ulcer with the formation of scar either on medical treatment alone or by additional minor interventions. Failure was defined as worsening of the ulcer necessitating therapeutic penetrating keratoplasty or evisceration.
Secondary outcome measure was best-corrected visual acuity at resolution and time to resolution between the 2 groups.
Evidence of ocular surface toxic reaction was assessed by follicular reaction in the lower forniceal conjunctiva, superficial punctate keratopathy, congestion in the lower bulbar conjunctiva.
Results :
There were 108 eyes of 108 patients enrolled in the study, with 54 in each group however 48 patients completed follow up in Group A and 46 patients in Group B. Complete resolution on medical management was noted in 38 (79.2%) eyes in Group A and 35 (76.1%) eyes in Group B. There was no difference in the time to resolution between Group A and Group B (41 days vs 50.5 days, p=0.35). Therapeutic PKP was done in 10 eyes (20.8%) in Group A and 12 eyes (26.1%) in Group B. The following isolates were found in each group : Group A Aspergillus (n=13), Dematiaceous (n=9), Fusarium (n=6) and Group B Aspergillus (n=8), Dematiaceous (n=9), Fusarium (n=9). Surface toxicity was seen in 5 cases in Group A and 2 patients in Group B.
Conclusions :
The combination of Natamycin and Voriconazole was not more effective than Natamycin alone in the treatment of fungal keratitis.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.