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

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.