Clinical observation of early postoperative wear of balafilcon A and innovative first-generation samfilcon a silicone hydrogel bandage contact lenses after SMILE surgery
Abstract
OBJECTIVES: Our objective was to compare the efficacy of two different silicone hydrogel bandage contact lenses on ocular surface after small incision lenticule extraction (SMILE) surgery. In this prospective, double-masked, contralateral, comparative clinical study, 25 patients who received SMILE in both eyes wore two different silicone hydrogel bandage contact lenses (BCLs): balafilcon A in one eye and samfilcon A in the other randomly. The scores of BCL deposits on the lens surface and the level of ocular discomfort were assessed on the first day after surgery. Ocular Surface Disease Index (OSDI), the 5-Item Dry Eye Questionnaire (DEQ-5), corneal sensitivity, ocular surface parameters and tear inflammatory mediators were assessed preoperatively and 1 day, 1 week, and 1 month postoperatively. DATA DESCRIPTION: There were no significant differences in subjective symptoms scores, OSDI scores, DEQ-5 scores, corneal sensitivity, ocular surface parameters or tear inflammatory mediators between the BCLs postoperatively (p > 0.05). Both samfilcon A and balafilcon A contact lenses are safe with equivalent efficacy on ocular surface after SMILE. The scores of BCL deposits were lower in the samfilcon A group than that in the balafilcon A group after SMILE (samfilcon A vs. balafilcon A: 1.28 ± 0.68 vs. 2.56 ± 0.82, P = 0.045). TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2400083482 (26 April 2024).
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 25 participants or records.
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