Long-Term Efficacy and Safety of 0.1% Cyclosporine A Cationic Emulsion in Advanced Dry Eye Disease: A 24-Month Retrospective Study

0.1%环孢素A阳离子乳剂治疗晚期干眼症的长期疗效和安全性:一项为期24个月的回顾性研究

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Abstract

Background: To evaluate the effectiveness of 0.1% cyclosporine A (CsA) cationic emulsion in managing advanced dry eye disease (DED), based on clinical parameters: Ocular Surface Disease Index (OSDI), best-corrected visual acuity (BCVA), Tear Break-Up Time (TBUT), corneal fluorescein staining (CFS) on the Oxford scale, Schirmer test, and intraocular pressure (IOP). Methods: This retrospective study included 20 patients (40 eyes) with severe DED unresponsive to previous therapies. All patients continued artificial tears and added 0.1% CsA once daily. Baseline assessments included OSDI, BCVA, TBUT, corneal staining, Schirmer test, and IOP. Follow-ups occurred at 1-3, 6, 12, and 24 months. Data were analyzed for treatment effect and progression over time. Results: The mean age was 53.5 ± 13.5 years; 80% were female. BCVA showed no significant changes. OSDI scores improved from severe (>53) to moderate (approximately 35). Schirmer test increased from ~6.2 mm to >10 mm (p < 0.001). TBUT improved from approximately 6 to 10 s (p < 0.001), with significant differences after 6 months. CFS scores decreased from 3.4 to 2.05 (p < 0.001), indicating reduced corneal damage. IOP remained stable throughout the study period. Conclusions: Long-term use of 0.1% cyclosporine A cationic emulsion led to marked and sustained improvement in both subjective symptoms and objective ocular surface parameters in severe dry eye disease. The therapy was safe, well tolerated, and did not affect visual acuity or intraocular pressure, supporting its value as a long-term treatment option.

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