Nationwide registry to track outcomes of corneal surgery and disease
Developing a Nationwide Registry to Track Longitudinal Clinical Outcomes of Corneal Surgery and Disease
This study is setting up a nationwide registry to track how well corneal surgeries and treatments work for patients, including those who receive corneal transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Keratoplasty Alliance International Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06101017 on ClinicalTrials.gov |
What this trial studies
This study aims to establish the first nationwide registry in the United States to monitor longitudinal clinical outcomes related to corneal diseases and surgeries, including corneal transplants. It will collect detailed information on donor tissue, recipient data, surgical procedures, and long-term outcomes to identify prognostic factors for successful corneal transplantation. Additionally, the study will create a database of historical imaging data to develop AI-based diagnostic and prognostic algorithms for corneal conditions. This prospective data collection will enhance clinical practice by providing real-world insights into corneal surgery outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study include individuals with corneal disease or those undergoing various types of corneal transplantation.
Not a fit: Patients who do not have corneal disease or are not undergoing corneal transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could significantly improve the understanding and management of corneal diseases and enhance patient outcomes following corneal transplantation.
How similar studies have performed: Other countries, such as Australia, have successfully implemented corneal graft registries, providing valuable insights into corneal transplant outcomes, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any criteria that does not meet the inclusion criteria above.
Where this trial is running
Baltimore, Maryland
- Keratoplasty Alliance International — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Priya M Mathews, MD — Keratoplasty Alliance International
- Study coordinator: Nitin G Vaswani, MD
- Email: nitin@manoshealth.com
- Phone: 7577263449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.