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Bhupesh Bagga, Savitri Sharma, Ruchi gour, Joveeta Joseph Ruben, Ashik Mohamed; Efficacy of voriconazole on Acanthamoeba Keratitis: Prospective Randomized Double masked trial. Invest. Ophthalmol. Vis. Sci. 2019;60(9):868.
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© ARVO (1962-2015); The Authors (2016-present)
To compare the efficacy of voriconazole with combination therapy of polyhexamethylene biguanide and chlorhexidine in the treatment of Acanthamoeba keratitis(AK).
Between August 2016 and March 2018, a prospective, randomized double masked clinical trial was conducted which was approved by the institutional review board (LEC 08/16/06/063) and registered (REF/2018/03/018176) with Clinical Trials Registry-India. Microbiologically confirmed cases of AK without prior exposure to either of the drugs were included in the study. Cases with mixed infection and corneal perforations were excluded from the study. After taking the informed consent, cases were allocated to either group A (PHMB 0.02% and Chlorhexidine 0.02%) or group B (Voriconazole 1%) as per a computer generated randomized list and allocation concealment by look-alike dispensers. A total of 23 patients were enrolled (A=11, B=12). Mean age of the patients was 40.3±14 years and male and female ratio was 10/11. The outcome of treatment was defined as resolved keratitis where there was complete resolution of infection, or resolving keratitis, where the widest diameter of the infiltrate reduced at least by 1mm from that of presentation.
Clinical characteristics of corneal ulcers at the time of presentation were identical in both the groups. Median logMAR visual acuity was 1.79(IQR, 1.0 to 2.78). Mean widest diameter of ulcer size was 5.5±1.6mm. At the end of one week of treatment 7 (70%) cases from group A and 9 (80%) cases from group B (p=0.64) were resolving. While, at their last visit of follow-up, 3 and 6 cases respectively had resolving keratitis (p=1.0), complete resolution was observed in 3 (30%) and 4 (36%) cases in group A and B (p=1.0). Median duration of follow-up was 69.5 days (IQR,24-117). Worsening of infection was noticed in 3 (30%) and 2 (18%) cases from group A and B, which exited from the study. In the group A, there was change of visual acuity from 1.79 (IQR,1.48-2.78) to 1.1(IQR, 0.48-1.78), (p=0.02) while in group B, from 1.60 (IQR,1-2.78) to 0.9(0.48-2.78) (p=0.11). Mean days of complete resolution were 73±26 and 43.5±14 in group A vs B(p=0.2).
This study shows equivalent efficacy of voriconazole and the combination therapy with the biguanides. Despite the limitation of small sample size, we believe that voriconazole can serve as a good alternative for the treatment of Acanthamoeba Keratitis.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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