Comparison of the efficacy of 0.05% cyclosporine A and 3% diquafosol sodium in treating dry eye after femtosecond laser corneal refractive surgery

Objective  To compare the efficacy of 0.05% cyclosporine A (CsA) and 3% diquafosol sodium (DQS) eye drops in treating dry eye following femtosecond laser corneal refractive surgery.

Methods  A stratified non-randomized controlled study was employed. A total of 126 patients who underwent femtosecond laser corneal refractive surgery between October 2023 and June 2024 at Beijing Tongren Eye Center were enrolled. Patients were stratified based on preoperative tear film break-up time (TFBUT), with a cutoff of ≥10 seconds: the tear film stable group receiving 0.4% polyethylene glycol (PEG) eye drops (PEG group, 41 eyes), and the 85 eyes with unstable tear film were divided into DQS (43 eyes) and CsA (42 eyes) groups using a random number table. The DQS group received 3% DQS eye drops+ 0.4% PEG eye drops, and the CsA group received 0.05% CsA eye drops+ 0.4% PEG eye drops. The different groups were further divided into the femtosecond laser-assisted in situ keratomileusis (FS-LASIK) subgroup and the small incision lenticule extraction (SMILE) subgroup according to the surgical method. The Chinese Dry Eye Questionnaire (CDEQ), TFBUT, Schirmer Ⅰ test (SⅠT), corneal fluorescein staining (CFS) score, lipid layer thickness (LLT), blinking rate, and partial blink ratio were evaluated preoperatively and 1 and 3 months postoperatively. The study was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of Beijing Tongren Hospital, Capital Medical University (No. TREC2023-036). Written informed consent was obtained from all participants prior to enrollment.

Results  The CDEQ score in the DQS group at 3 months after surgery was significantly lower than that before surgery and 1 month after surgery (both P<0.05). The CDEQ score in the CsA group at 1 and 3 months after surgery was significantly lower than that before surgery, and the CDEQ score at 3 months after surgery was significantly lower than that at 1 month after surgery (all P<0.05). The preoperative CDEQ score in the PEG group was significantly lower than that in the DQS group and the CsA group (both P<0.05), and there were no statistically significant differences in CDEQ scores among the different groups at each time point after surgery (all P>0.05). TFBUT increased at 1 and 3 months after surgery in the DQS group and CsA group compared with that before surgery, and increased at 3 months after surgery compared with 1 month after surgery, with statistically significant differences (all P<0.05). The preoperative TFBUT in the PEG group was significantly higher than that in the DQS group and CsA group (both P<0.05), and there was no statistically significant difference in TFBUT among the various groups at each time point after surgery (all P>0.05). The SⅠT at 3 months after surgery in the DQS group and CsA group was significantly higher than that at 1 month after surgery (all P<0.05). In the FS-LASIK subgroup, the SⅠT at 1 month after surgery in the DQS group was significantly higher than that in the PEG group and CsA group (both P<0.05). In the SMILE subgroup, the SⅠT at 3 months after surgery in the DQS group and CsA group was significantly higher than that at 1 month after surgery (both P<0.05). In the FS-LASIK subgroup, the CFS score at 3 months after surgery in the DQS group and CsA group was lower than that at 1 month after surgery, the CFS scores at 1 and 3 months after surgery in the CsA group were lower than those in the PEG group, and the CFS score at 3 months after surgery in the CsA group was lower than that in the DQS group, showing statistically significant differences (all P<0.05). In the SMILE subgroup, the CFS scores at 3 months after surgery in the DQS group and CsA group were lower than those before surgery and at 1 month after surgery, and the CFS scores at 1 and 3 months after surgery in the DQS group and CsA group were lower than those in the PEG group, with statistically significant differences (all P<0.05). The LLT at 3 months after surgery in the CsA group increased compared with that at 1 month after surgery, and the LLT at 1 and 3 months after surgery in the DQS group was significantly higher than that in the PEG group and the CsA group, and the LLT at 3 months after surgery in the CsA group was higher than that in the PEG group, showing statistically significant differences (all P<0.05).

Conclusions  Perioperative use of 0.05% CsA or 3% DQS eye drops can effectively improve postoperative dry eye symptoms and ocular surface function after corneal refractive surgery. However, their therapeutic profiles differ. DQS appears to be more effective in enhancing tear secretion and maintaining tear film stability, whereas CsA shows greater efficacy in reducing corneal epithelial damage. In FS-LASIK patients, early combination of CsA can help repair corneal epithelium, while DQS can more effectively stimulate tear secretion and help improve tear film stability.