Effects of 0.05% cyclosporine, diquafosol sodium, and perfluorohexyloctane eye drops on ocular surface parameters after cataract surgery in patients with type 2 diabetes: a randomized controlled trial

Objective To compare the short-term effects of cyclosporine, diquafosol sodium, and perfluorohexyloctane on objective ocular surface parameters after cataract surgery in patients with type 2 diabetes. Methods In this prospective randomized trial, 144 patients with type 2 diabetes (144 eyes) were randomly assigned to receive standard postoperative care alone or with adjunctive 0.05% cyclosporine, 3% diquafosol sodium, or perfluorohexyloctane eye drops. Of these, 120 (83.3%) completed the 4-week follow-up and were included in the per-protocol analysis. Tear film lipid layer thickness (LLT), tear break-up time (BUT), tear meniscus height (TMH), tear ferning grade, and Schirmer I test (SIT) values were assessed preoperatively and on postoperative day 1 and at weeks 1, 2, 3, and 4. Baseline glycated hemoglobin (HbA1c), diabetes duration, and insulin use were explored as potential modifiers of treatment effects. Results Treatment-by-time interactions were observed for all five outcomes (all P < 0.001). After multiplicity adjustment, cyclosporine showed a greater increase in BUT than standard control at week 4 (difference, 5.0 s; adjusted CI, 2.7–7.0). Diquafosol showed greater reductions in tear ferning grade and greater increases in Schirmer I values at weeks 3 and 4. At week 4, the respective differences were −1.0 grade (adjusted CI, −2.5 to −1.0) and 5.0 mm (1.0–7.0). No adjusted LLT or TMH comparison interval excluded zero. Conclusions Compared with standard care, 0.05% cyclosporine yields short-term improvements in BUT, and diquafosol sodium produces short-term benefits in the Schirmer I test and tear ferning grade. These findings are limited to objective signs and cannot establish an overall treatment ranking among the three agents. Trial registration Chinese Clinical Trial Registry https://www.chictr.org.cn/bin/project/edit?pid=265508 , ChiCTR2500099433. Reg date: 2025-03-24.