Tear biomarker changes and ocular surface recovery with low-level light therapy after cataract surgery: a double-masked randomized controlled clinical trial
Abstract
Dry eye disease (DED) is a common complication following cataract-surgery, potentially impairing visual recovery. Low-level light therapy (LLLT) has emerged as a noninvasive approach to improve ocular surface status. This study evaluated the perioperative effects of LLLT on ocular surface modulation by correlating clinical outcomes with tear biomarker dynamics and developing predictive models to identify patients most likely to benefit from LLLT. Of the 98 patients initially randomized, 88 were included in the final analysis, with 44 allocated to the LLLT group and 44 to the sham treatment group. Clinical evaluation-including Ocular Surface Disease Index (OSDI) as the primary outcome, and tear breakup time, Schirmer test, and tear osmolarity as secondary endpoints-was performed preoperatively and one month postoperatively to classify patients as preclinical or having DED. Tear levels of biomarkers involved in tissue repair and neurotrophic-signaling (GDF-15,β-NGF, VEGFA, PDGF-AB, PDGF-CC) and inflammation (OPN, OPG, TNF-α) were assessed as exploratory endpoints and quantified using Luminex-FlexMap3D technology. LLLT-treated patients showed significantly higher clinical improvement post-cataract surgery than sham controls (44.2% vs. 4.4%; p < 0.0001). In DED patients, LLLT significantly increased GDF-15 (77.6 ± 7.2 to 95.5 ± 7.4 pg/mL; p = 0.0112) and PDGF-CC (711.4 ± 76.6 to 1024 ± 130.8 pg/mL; p = 0.0473). The LLLT-induced β-NGF increase was more pronounced in preclinical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 98 participants or records.
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