Impact of Topical 0.05% Cyclosporine A Eye Drops on Post-Femtosecond-Assisted Laser In Situ Keratomileusis Ocular Surface Recovery: A Randomized Clinical Trial

Abstract

Objectives: To investigate the effect of topical 0.05% cyclosporine A (CsA) eye drops as an adjunct to conventional therapy in maintaining post-femtosecond-assisted laser in situ keratomileusis (FS-LASIK) ocular surface stability.

Methods: Sixty-six patients (eyes) undergoing FS-LASIK were randomized into 2 groups: 33 patients (eyes) in group I (conventional treatment group) and 33 patients (eyes) in group II (CsA group). Conventional treatments include topical levofloxacin, fluorometholone, and artificial tears. Group II received topical 0.05% CsA eye drops twice daily for three months in addition to conventional treatment. Ocular Surface Disease Index (OSDI), numerical rating scale (NRS), tear break-up time (TBUT), Schirmer I test (SIt), corneal fluorescein staining (CFS), conjunctival lissamine green (LG) staining, corneal sensitivity, and corneal nerve morphology were measured. In addition, tear inflammatory cytokine levels were measured using the Luminex assay. Follow-up was performed preoperatively and 1 and 3 months postoperatively.

Results: In the CsA group, OSDI, TBUT, LG, corneal sensitivity, and corneal nerve fiber total branch density recovered better than in the conventional treatment group. As for tear inflammatory cytokines, interferon (INF) -γ, interleukin (IL)-10, and IL-6 levels were significantly higher in the conventional treatment group as compared with the CsA group. In addition, no significant differences in NRS, SIt, and CFS scores were observed between the two groups.

Conclusion: In conclusion, 0.05% CsA eye drops is a useful adjunct to conventional treatment for restoring the ocular surface stability after corneal refractive surgery and is more potent in sustaining anti-inflammatory effects.

FIG. 1.

Changes in OSDI (A), TBUT (B), and LG (C) scores over time for both groups. OSDI, Ocular Surface Disease Index; TBUT, tear break-up time; LG, lissamine green. Blue asterisks indicate significant within-group differences for the CsA group at postoperative time points compared with the baseline. Red asterisks indicate significant within-group changes for the conventional treatment group. Black asterisks between the two lines highlight significant differences between the CsA and conventional treatment groups over time. *P<0.05; **P<0.01; ***P<0.001; ns, no significance.

FIG. 2.

Changes in central (A), superior (B), nasal (C), temporal (D), inferior (E), and mean corneal sensitivity (F) over time for both groups. Blue asterisks indicate significant within-group differences for the CsA group at postoperative time points compared with the baseline. Red asterisks indicate significant within-group changes for the conventional treatment group. Black asterisks between the two lines highlight significant differences between the CsA and conventional treatment groups over time. *P<0.05; **P<0.01; ***P<0.001; ns, no significance.

FIG. 3.

Changes in CNBD (A), CNFD (B), CNFL (C), and CTBD (D) values over time for both groups. CNFD, corneal nerve fiber density; CNBD, corneal nerve branch density; CNFL, corneal nerve fiber length; CTBD, corneal nerve fiber total branch density. Blue asterisks indicate significant within-group differences for the CsA group at postoperative time points compared with the baseline. Red asterisks indicate significant within-group changes for the conventional treatment group. Black asterisks between the two lines highlight significant differences between the CsA and conventional treatment groups over time. *P<0.05; **P<0.01; ***P<0.001; ns, no significance.

FIG. 4.

Changes in tear INF-γ (A), IL-10 (B), and IL-6 (C) levels over time for both groups. INF-γ, interferon-γ; IL, interleukin. Blue asterisks indicate significant within-group differences for the CsA group at postoperative time points compared with the baseline. Red asterisks indicate significant within-group changes for the conventional treatment group. Black asterisks between the two lines highlight significant differences between the CsA and conventional treatment groups over time. *P<0.05; **P<0.01; ***P<0.001; ns, no significance.