Developing a Nationwide Registry to Track Longitudinal Clinical Outcomes of Corneal Surgery and Disease
Completed
Conditions studied: Corneal Disease, Endothelial Corneal Dystrophy, Corneal Transplant Failure, Corneal Transplant Rejection
In brief
The goal is to develop a nationwide registry to track longitudinal clinical outcomes of and store imaging data related to numerous corneal conditions. There are two main objectives including the establishment of the first nationwide corneal transplant registry in the United States to include information related to the donor tissue, recipient, surgical procedure, and long-term clinical outcomes. Ultimately, this prospective data collection will allow us to determine prognostic factors for successful corneal transplantation and create an algorithm to guide clinical practice based on real world outcomes. The second objective is to collect and create a database of historical, de-identified optical coherence topography (OCT) and corneal topography images to ultimately develop artificial intelligence (AI) based diagnostic and prognostic algorithms for corneal disease and surgery.
Key facts
- Study ID
- NCT06101017
- Run by
- Nitin Vaswani
- People needed
- 19
- Starts
- 2023-10-12
- Expected to finish
- 2024-08-15
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All subjects with corneal disease or undergoing corneal transplantation (either penetrating keratoplasty, endothelial keratoplasty [including DSAEK and DMEK], or anterior lamellar keratoplasty are eligible to be included in this study. Imaging studies performed pre-operatively, up until 1 year prior to surgery will be collected. Studies may include the following:
- OCT
- Corneal topography
- Specular biomicroscopy
- In vivo confocal biomicroscopy
You may not qualify if…
- Any criteria that does not meet the inclusion criteria above.
Where it is running
- Keratoplasty Alliance International — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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