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National Eye Institute Supported Randomized Controlled Trials in Keratoplasty for Endothelial Disorders: Lessons
Ahmed F Omar1,2, Loretta B Szczotka-Flynn1, Beth Ann Benetz1
1Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, OH; and.
Cornea
|August 25, 2025
Summary
National Eye Institute (NEI)-funded randomized controlled trials (RCTs) have advanced corneal transplantation for endothelial disorders. These studies provide crucial evidence for eye banking and surgical practices, guiding future innovations in treating corneal diseases.
Area of Science:
- Ophthalmology
- Corneal Transplantation
- Clinical Trials
Background:
- Randomized controlled trials (RCTs) provide the highest level of clinical evidence in ophthalmology.
- NEI-funded RCTs have significantly impacted keratoplasty for endothelial disorders.
- Previous studies often relied on retrospective data, limiting definitive conclusions.
Purpose of the Study:
- To summarize findings from NEI-sponsored keratoplasty RCTs.
- To review non-NEI funded keratoplasty RCTs.
- To compare RCT findings with keratoplasty registry data.
- To discuss future directions for RCTs in keratoplasty and eye banking.
Main Methods:
- Systematic review of NEI-funded keratoplasty RCTs.
- Inclusion of select non-NEI funded keratoplasty RCTs.
- Comparative analysis with major keratoplasty registry data.
- Discussion of potential future RCT topics.
Main Results:
- NEI RCTs have addressed key aspects: histocompatibility, donor tissue characteristics, storage, and surgical factors.
- RCTs have clarified controversies and validated emerging practices in endothelial keratoplasty.
- Findings from RCTs have directly influenced eye banking and clinical keratoplasty procedures.
Conclusions:
- NEI-funded RCTs have been pivotal in advancing the understanding and practice of keratoplasty for endothelial disorders.
- These trials provide a strong evidence base for current practices and future innovations.
- Future RCTs are essential for continued progress in surgical management and eye banking.

