Efficacy of perioperative 0.05% cyclosporine A for dry eye in cataract patients: a randomized controlled clinical trial

Authors:Zhumahan Tuokedaerhan, Wang Yan, Li Xiaolong, Cheng Wanying, Gao Yunxian

Corresponding author: Gao Yunxian, Email:gaoyx1973@163.com

Published:2026-10-10

DOI:10.3760/cma.j.cn115989-20250602-00179


ABSTRACT 

Objective To evaluate the efficacy of 0.05% cyclosporine A eye drops for the perioperative treatment of dry eye in patients to undergo cataract surgery.

Methods A randomized controlled study was conducted. Sixty patients (60 eyes) with cataract and mild-to-moderate dry eye disease treated at Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University between December 2021 and March 2022 were enrolled. Patients were randomly assigned to a 0.05% cyclosporine A group (30 cases, 30 eyes) or a control group (30 cases, 30 eyes) using opaque sealed envelopes (SNOSE). Both groups received conventional perioperative treatment, including warm compresses, meibomian gland massage, sodium hyaluronate eye drops, and levofloxacin eye drops before surgery, followed by tobramycin-dexamethasone eye drops, sodium hyaluronate eye drops, and tobramycin-dexamethasone ophthalmic ointment after surgery. In addition to conventional treatment, the 0.05% cyclosporine A group received 0.05% cyclosporine A eye drops twice daily for 3 months. The Ocular Surface Disease Index (OSDI) score, Schirmer Ⅰ test (SⅠt), breakup time of tear film (BUT), and corneal fluorescein staining (CFS) score were assessed before treatment and at 1 week, 1 month, and 3 months after surgery. This study complied with the Declaration of Helsinki. The study protocol was reviewed and approved by the Ethics Committee of Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University (No. 2022-XE0102-1), and all patients signed the informed consent form.

Results There was no significant significance in the overall differences in OSDI scores and CFS scores between the control group and the 0.05% cyclosporine A group (Fgroup=0.529, 3.057; both P>0.05), and there were statistical significance in the overall comparison between before and after treatment (Ftime=241.956, 143.273; both P<0.001). The SⅠt before treatment and 1 week, 1 month and 3 months after treatment in the control group were (4.67±1.77), (4.57±1.74), (5.83±1.78), (6.97±1.52)mm/5 minutes, respectively, BUT were (4.80±1.35), (5.27±1.51), (5.83±1.53), (5.77±0.86) seconds, respectively; in the 0.05% cyclosporine A group, the SⅠt were (4.03±1.35), (4.33±1.09), (7.23±1.41), (9.63±1.97)mm/5 minutes, and the BUT were (4.57±1.17), (4.70±1.62), (6.70 ±1.79), and (8.47±1.25) seconds, respectively. The overall differences in SⅠt and BUT between the control group and the 0.05% cyclosporine A group before and after treatment were statistically significant (SⅠt: Fgroup=6.937, P=0.011; Ftime=90.641, P<0.001. BUT: Fgroup=9.679, P=0.003; Ftime=60.367, P<0.001), among which SⅠt and BUT in the 0.05% cyclosporine A group were higher than those in the control group 1 and 3 months after treatment, and the differences were statistically significant (both P<0.05).

Conclusions Perioperative treatment with 0.05% cyclosporine A eye drops improves objective signs of dry eye disease in patients undergoing cataract surgery. Compared with conventional treatment alone, cyclosporine A eye drops are associated with improved tear film stability and tear secretion.

KEYWORDS:

Dry eye disease;Cyclosporine A;Cataract;Phacoemulsification


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Authors Info & Affiliations 

Zhumahan Tuokedaerhan

Department of Ophthalmology, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, The Traditional Chinese Medicine Research Institute of Xinjiang Uygur Autonomous Region, Urumqi 830000, China

Wang Yan

Department of Ophthalmology, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, The Traditional Chinese Medicine Research Institute of Xinjiang Uygur Autonomous Region, Urumqi 830000, China

Li Xiaolong

Department of Ophthalmology, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, The Traditional Chinese Medicine Research Institute of Xinjiang Uygur Autonomous Region, Urumqi 830000, China

Cheng Wanying

Department of Ophthalmology, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, The Traditional Chinese Medicine Research Institute of Xinjiang Uygur Autonomous Region, Urumqi 830000, China

Gao Yunxian

Department of Ophthalmology, Traditional Chinese Medicine Hospital Affiliated to Xinjiang Medical University, The Traditional Chinese Medicine Research Institute of Xinjiang Uygur Autonomous Region, Urumqi 830000, China


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