Clinical efficacy of topical 0.1% tacrolimus in patients with corneal neovascularization: A prospective, multicenter, randomized controlled pilot trial.
6 affiliations
- 1Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
- 2Department of Ophthalmology, Korea University College of Medicine, Seoul, Republic of Korea.
- 3YES Eye Clinic, Seoul, Republic of Korea.
- 4The Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Republic of Korea.
- 5The Corneal Dystrophy Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
- 6Center for Cell Therapy, Asan Medical Center, Seoul, Republic of Korea.
Abstract
To evaluate the effect of topical 0.1% tacrolimus on corneal neovascularization (CoNV) and compare its efficacy with 1% prednisolone acetate. In this prospective, multicenter, evaluator-masked, randomized study, patients with CoNV were randomized to 0.1% tacrolimus or 1% prednisolone acetate. Eye drops were administered four times daily for 4 weeks, then twice daily for an additional 4 weeks. Clinical assessments included CoNV grade, visual acuity, intraocular pressure, and ocular surface staining scores. A linear mixed model was used to evaluate treatment effects. Forty-six patients (tacrolimus group, n = 24; prednisolone group, n = 22) were analyzed. Most baseline characteristics were comparable between groups, except for endothelial cell density, which was significantly lower in the tacrolimus group (P = 0.040). In both groups, CoNV grade decreased significantly from baseline to week 4 (tacrolimus group: 2.025 ± 0.162 to 1.733 ± 0.162, P = 0.003; prednisolone group: 1.852 ± 0.168 to 1.625 ± 0.168, P = 0.035), with no significant between-group difference (P = 0.688). No significant change in CoNV grade was observed from week 4 to week 8 in either group. Over the 8-week period, significant within-group decrease in CoNV grade was observed in the tacrolimus group only (2.025 ± 0.162 to 1.697 ± 0.164, P = 0.019). Both 0.1% tacrolimus and 1% prednisolone acetate reduced CoNV during the first 4 weeks. The sustained reduction in CoNV through 8 weeks in the tacrolimus group suggests its potential as an alternative or adjunctive therapy for CoNV, warranting further investigation.
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BibTeX
@article{song2026clinical,
title = {{Clinical efficacy of topical 0.1% tacrolimus in patients with corneal neovascularization: A prospective, multicenter, randomized controlled pilot trial.}},
author = {Myung-Sun Song and Youngsub Eom and Ikhyun Jun and Hun Lee},
journal = {Advances in ophthalmology practice and research},
year = {2026},
month = aug,
doi = {10.1016/j.aopr.2026.08.001},
url = {https://europepmc.org/article/MED/42999712},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Clinical efficacy of topical 0.1% tacrolimus in patients with corneal neovascularization: A prospective, multicenter, randomized controlled pilot trial.
AU - Myung-Sun Song
AU - Youngsub Eom
AU - Ikhyun Jun
AU - Hun Lee
PY - 2026
DA - 2026/08/05
JO - Advances in ophthalmology practice and research
DO - 10.1016/j.aopr.2026.08.001
UR - https://europepmc.org/article/MED/42999712
AB - To evaluate the effect of topical 0.1% tacrolimus on corneal neovascularization (CoNV) and compare its efficacy with 1% prednisolone acetate. In this prospective, multicenter, evaluator-masked, randomized study, patients with CoNV were randomized to 0.1% tacrolimus or 1% prednisolone acetate. Eye drops were administered four times daily for 4 weeks, then twice daily for an additional 4 weeks. Clinical assessments included CoNV grade, visual acuity, intraocular pressure, and ocular surface staining scores. A linear mixed model was used to evaluate treatment effects. Forty-six patients (tacrolimus group, n = 24; prednisolone group, n = 22) were analyzed. Most baseline characteristics were comparable between groups, except for endothelial cell density, which was significantly lower in the tacrolimus group (P = 0.040). In both groups, CoNV grade decreased significantly from baseline to week 4 (tacrolimus group: 2.025 ± 0.162 to 1.733 ± 0.162, P = 0.003; prednisolone group: 1.852 ± 0.168 to 1.625 ± 0.168, P = 0.035), with no significant between-group difference (P = 0.688). No significant change in CoNV grade was observed from week 4 to week 8 in either group. Over the 8-week period, significant within-group decrease in CoNV grade was observed in the tacrolimus group only (2.025 ± 0.162 to 1.697 ± 0.164, P = 0.019). Both 0.1% tacrolimus and 1% prednisolone acetate reduced CoNV during the first 4 weeks. The sustained reduction in CoNV through 8 weeks in the tacrolimus group suggests its potential as an alternative or adjunctive therapy for CoNV, warranting further investigation.
SN - 2667-3762
ER -