Study protocol for a randomised controlled trial to evaluate the prophylactic efficacy of combined intense pulsed light (IPL) and low-level light therapy (LLLT) in preventing laser corneal refractive surgery-induced dry eye: the Treat Eye Before Laser induced Dry (TEBeLiD) study.

Abstract

Laser corneal refractive surgery is a widely adopted approach for correcting refractive errors, but postoperative dry eye remains a common side effect. Intense pulsed light (IPL) and low-level light therapy (LLLT) are two emerging treatments that have shown potential in managing dry eye disease. However, their role as a prophylactic treatment in patients without pre-existing symptomatic dry eye undergoing refractive surgery has not been explored. This is a single-blind, randomised controlled trial comparing the prophylactic efficacy of combined IPL and LLLT treatment versus standard care in preventing dry eye after laser corneal refractive surgery (FS-LASIK, SMILE or PRK). Eligible patients aged 18 or older scheduled for surgery will be randomly assigned in a 1:1 ratio to either the treatment or control group. The primary endpoint is the French version of Ocular Surface Disease Index score at 1 month postoperatively. Secondary outcomes include Fluorescein Break-Up Time, Schirmer I test, Oxford score and Meibomian Gland Dropout. Data will be analysed using a mixed-effects linear model adjusted for surgery type and baseline dry eye parameters. The study started in June 2023 and end in April 2025 but data have not been yet analysed. The study has been approved by the Institutional Review Board Est III, France, and registered on ClinicalTrials.gov (NCT05803798). All participants will provide written informed consent. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences. NCT05803798.