To evaluate the safety and performance of a crosslinked thiolated carboxymethyl hyaluronic acid liquid-gel (CMHA-S) ocular bandage gel in accelerating reepithelialization of corneal defects created for photorefractive keratectomy (PRK).
Three community-based clinical research sites.
Prospective case series.
Patients scheduled for bilateral PRK had both eyes randomized immediately after PRK to Group 1 (ocular bandage gel 4 times a day for 14 days and bandage contact lens), Group 2 (ocular bandage gel 4 times a day for 14 days), or Group 3 (control; bandage contact lens and artificial tears 4 times a day for 14 days). Patients received a 9.0 mm epithelial defect for PRK and were followed through 28 days postoperatively. Safety assessments included adverse events, vision, pain, slitlamp, intraocular pressure, and fundus examinations. The primary performance endpoint was time to corneal reepithelialization after PRK.
The study comprised 39 patients. The ocular bandage gel was well tolerated. The time to reepithelialization was 3 days for 54.5%, 80.0%, and 45.5% of patients in Group 1, Group 2, and Group 3, respectively. Compared with measurements in the control group, the mean horizontal and vertical defect lengths in Group 2 (ocular bandage gel alone) were 36.9% and 29.0% smaller, respectively, by 1 day.
Crosslinked hyaluronic acid showed the ability to quickly reepithelialize the cornea and may promise a well-tolerated and effective therapy for ocular wound care after trauma, disease, or surgery.