Clinical Effects and Safety of 3% Diquafosol Ophthalmic Solution for Patients With Dry Eye After Cataract Surgery: A Randomized Controlled Trial

Abstract

PURPOSE: To compare the efficacies and safety profiles of 3% diquafosol and 0.1% sodium hyaluronate in patients with dry eye after cataract surgery. DESIGN: Randomized controlled trial. METHODS: SETTING: Soonchunhyang University Hospital, Seoul, South Korea. STUDY POPULATION: In all, 130 eyes of 86 dry eye patients who had undergone cataract surgery between January 2014 and January 2015 were enrolled and randomly divided into a diquafosol group and a sodium hyaluronate group. INTERVENTION: The diquafosol group used diquafosol 6 times a day and the hyaluronate group used sodium hyaluronate 6 times a day after cataract surgery. MAIN OUTCOME MEASURES: Evaluations of efficacy were conducted based on an Ocular Surface Disease Index questionnaire, tear breakup time (TBUT), Schirmer I test, corneal fluorescein and conjunctival lissamine green staining scores, serial measurement of ocular higher-order aberrations (HOAs), corneal HOAs, and uncorrected distance visual acuity test. Safety evaluations were based on anterior chamber inflammation and discontinuation of the eye drops. RESULTS: Objective signs and subjective symptoms were aggravated at 1 week postoperatively and began to recover significantly 4 weeks after surgery. The diquafosol group showed significantly superior TBUT (P<.001), corneal fluorescein (P=.045), and conjunctival staining (P=.001) compared to the sodium hyaluronate group throughout the study period. TBUT (P<.001) and the change in HOAs (P=.018) recovered significantly more quickly in the diquafosol group. The safety evaluations showed no intergroup differences. CONCLUSIONS: Eye drops of 3% diquafosol may be an effective and safe treatment for the management of cataract surgery-induced dry eye aggravation in patients with preexisting dry eye. (C) 2016 by Elsevier Inc. All rights reserved.