BMJ Open · 17 authors, 7 centres
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This is a protocol for a three-arm randomised controlled trial (IPL alone, 3% diquafosol alone, and IPL combined with 3% diquafosol) enrolling 360 patients with evaporative dry eye disease to assess whether the combination is more effective than either intervention alone.
Participants will be randomly assigned to IPL alone, 3% diquafosol ophthalmic solution alone, or IPL combined with diquafosol, with follow-up at 14 and 28 days. Primary outcomes are NITBUT and OSDI score change from baseline; secondary outcomes include ocular surface staining, meibomian gland function, tear film lipid layer score, tear meniscus height, and conjunctival hyperemia. Sample size was calculated using a two-tailed t-test with 80% power, 5% significance level, and a 10% dropout allowance. Analyses will use repeated measures and ANCOVA with baseline as covariate.
