To assess the efficacy of BTX-A, the researchers reviewed literature from multiple major databases, including PubMed, Cochrane Library, Web of Science, Scopus, and Embase, covering studies published up to December 2024. They included both randomized controlled trials and non-randomized studies that investigated the effects of BTX-A on dry eye parameters such as tear breakup time (TBUT), Schirmer test scores, tear meniscus height (TMH), and Ocular Surface Disease Index (OSDI) scores.
A total of 14 studies involving 634 patients were included in the analysis, which led to the following key findings:
- Pooled data from 10 studies involving 513 participants showed significant improvements in clinical outcomes following Botulinum toxin A (BTX-A) treatment.
- Tear breakup time (TBUT), indicating tear film stability, increased by 1.79 seconds.
- Schirmer test scores, used to evaluate tear production, improved by 3.72 mm.
- Ocular Surface Disease Index (OSDI) scores, reflecting patient-reported symptoms, decreased by 7.51 points.
- Tear meniscus height (TMH), representing tear volume, increased by 0.10 mm.
- All improvements were statistically significant.
- BTX-A is believed to relieve symptoms by modulating neurosensory pathways and reducing excessive blinking or muscle spasms.
- These effects help enhance tear film retention and protect the ocular surface.
The analysis also accounted for study variability by using both fixed- and random-effects models, ensuring the robustness of results despite differences in study designs and populations.
The authors wrote, "Given the growing prevalence of dry eye disease worldwide—often exacerbated by screen use, aging, and environmental stressors—these findings offer strong evidence for incorporating BTX-A into clinical practice."
"While further large-scale studies are encouraged to establish optimal dosing and injection protocols, the current evidence supports BTX-A as a promising and effective intervention for improving tear function and relieving symptoms in patients with dry eye disease," they concluded.
Reference:
Chen, K., Chan, H., & Chan, C. (2025). Is Botulinum toxin A effective in treating dry eye disease? A systematic review and meta-analysis. Eye, 39(8), 1457-1464. https://doi.org/10.1038/s41433-025-03790-6
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