EFFICACY OF TOPICAL TACROLIMUS (FK506) IN HIGH-RISK PENETRATING KERATOPLASTY: A SYSTEMATIC REVIEW AND META-ANALYSIS OF COMPARATIVE STUDIES
Published 2025 - 29th ESCRS Winter Meeting
Reference: FP05.01 | Type: Free Paper | DOI: 10.82333/3h3s-zf79
Authors: Jumanah Qedair* 1 , Razan Bawazir 2 , Saeed Alghamdi 3
1College of Medicine,King Saud bin Abdulaziz University for Health Sciences, Jeddah,Saudi Arabia;King Abdullah International Medical Research Center (KAIMRC), Jeddah,Saudi Arabia, 2College of Medicine,King Saud bin Abdulaziz University for Health Sciences, Jeddah,Saudi Arabia, 3Department of Ophthalmology,King Abdulaziz Medical City, Ministry of National Guard — Health Affairs, Jeddah,Saudi Arabia
Purpose
Corneal transplant rejection poses a significant challenge for patients undergoing penetrating keratoplasty (PKP). We aim to systematically review the literature to evaluate the efficacy of combining topical tacrolimus with steroids in reducing graft failure rates in these vulnerable patients.
Setting
Systematic Review and Meta-analysis
Methods
A systematic review and meta-analysis, registered with PROSPERO (ID: CRD42024585962), were conducted according to the PRISMA guidelines. Weighted means, proportional, and log odds ratios meta-analyses were conducted for pooled means, proportions, and log odds ratios, using the random-effects model. Subgroup analysis was done to test statistical differences between groups. Two-tailed p-value of <0.05 was considered statistically significant.
Results
We included a total of six homogenous comparative studies (RCT = 2 and Cohort = 4), resulting in a total of 314 patients who underwent high-risk PKP. The tacrolimus-plus-steroids group consisted of 158 patients, whereas the steroids-alone group included 156 patients. There was an overall male predominance (n = 192, 61.0% [95% CI: 54.0% — 67.0%]). In the tacrolimus-plus-steroids group, the male patients constituted 63.0% of the cohort (95% CI: 54.0% — 71.0%) compared to the steroids-alone group (59.0% [95% CI: 48.0% — 70.0%], p = 0.64). The weighted mean age for the tacrolimus-plus-steroid group was 51.4 years (95% CI: 35.9 years — 66.8 years) compared to the steroids-alone group, which was 53.9 years (95% CI: 42.3 years — 65.5 years, p = 0.95). Pooling odds ratios (OR) of graft failure in both tacrolimus-plus-steroid group and steroids-alone resulted in an overall statistically significant finding. After undergoing high-risk PKP, patients in the tacrolimus-plus-steroids group showed significantly lower odds of graft failure and are 74.0% less likely to experience graft failure (OR: 0.26 [95% CI: 0.15 OR — 0.42 OR]) compared to patients in the steroids-alone group (p = 0.01).
Conclusion
While high rejection risk patients may struggle to preserve their corneal transplant, the addition of topical tacrolimus to steroid therapy significantly reduces risk of graft failure after PKP. These findings support the use of topical tacrolimus as a standard adjunct in high-risk transplant patients to improve their graft survival and overall clinical outcome.