Abstract
Purpose :
To compare the efficacy and safety of accelerated CXL as adjuvant versus conventional treatment in subjects with infectious keratitis.
Methods :
This randomized double-blind clinical trial was conducted in Mexico City in two tertiary Eye Care Center: Instituto de Oftalmologia “Fundacion Conde de Valenciana” and Asociacion Para Evitar la Ceguera en Mexico, between March 2016 to March 2017. Randomized block design was performed. This study was approved by the Ethics Committee of both centers. Written informed consent was obtained from all subjects after a detailed explanation of the nature of the study.
Inclusion criteria were: The diagnosis of infectious keratitis was made by cornea specialists. All patients underwent slit-lamp biomicroscopy at day 1, week 1, month 1 and month 3. Only patients with infiltration diameter greater than 3 mm were included. The study excluded subjects with a history of herpetic keratitis, Acanthamoeba keratitis and systemic immunosuppression.
Four groups of eyes (intervention and control) were randomized: 1) Refractory keratitis treated with conventional management plus placebo; 2) Refractory keratitis treated with conventional management plus CXL; 3) Initial keratitis treated with conventional management plus placebo and 4) Initial keratitis treated with conventional management plus CXL.
The intervention group received accelerated CXL (30 mW/cm2 Avedro Inc Waltham USA), and the control group received the emission of a white light adapted to the accelerated CXL equipment. Participants and care givers were blinded to group assignment.
Results :
We included 6 subjects, 75% of the cases presented adverse events in the experimental group versus 0% in the control group. Adverse events were reported to the Ethics Committee and it was suspended. When comparing the response variable between groups; 25% showed healing in the experimental group versus 50% in the control group.
Conclusions :
The results of our study suggest that accelerated CXL is probably ineffective for adjuvant treatment in infectious keratitis. Due to the high percentage of adverse events, a small number of participants was included before being arrested, so the possibility of generalizing these results is not clear. We observed that accelerated CXL could have an unfavorable effect on keratolysis in 75% of cases.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.