Reduced Ocular Surface Inflammation in SMILE Patients: The Beneficial Outcome of 0.1% Ciclosporin Cationic Emulsion Treatment

After laser refractive surgery, dry eye disease is a common issue, primarily caused by inflammation. In a cohort of patients undergoing small incision lenticule extraction (SMILE), we examined the impact of anti-inflammatory drug ciclosporin (0.1% in cationic emulsion; CsA-CE) on the corneal fluorescein staining (CFS) score and other indicators of dry eye disease. This non-randomized, interventional, comparative study enrolled 30 patients undergoing SMILE, who received a once-daily, preservative-free, single-dose formulation of CsA-CE for one month following surgery. Tear osmolarity, ocular surface disease index (OSDI) scores, and CFS scores were measured after one- and three-months following surgery and compared to a control group (n=30). In the CsA-CE group, 26 patients completed the follow-up at Month 1, compared to 28 patients in the control group. At three-months follow-up, 22 patients in the CsA-CE group and 23 in the control group remained. At Month 1 and Month 3 postoperative follow-up, the CsA CE group's CFS scores were significantly lower compared to controls: 0.31 ± 0.74 vs 0.75 ± 0.89 (P = 0.02) and 0.05 ± 0.21 vs 0.43 ± 0.84 (P = 0.04), respectively. Mean CFS scores of CsA-CE group were 0.44 (Month 1) and 0.38 (Month 3) lower postoperatively, compared to the control group. Tear osmolarity and OSDI scores, however, did not significantly differ between the two groups and stayed within normal bounds. With 57.7% of patients reporting no instillation site pain and no other side effects, the treatment was well-tolerated. The anti-inflammatory effect of CsA-CE application in the early postoperative period after SMILE resulted in significantly lower CFS scores at Months 1 and 3 in comparison to the control group. These results suggest that 0.1% CsA-CE treatment lowers ocular surface damage and might thus benefit the recovery process of patients treated with this form of laser refractive surgery.