RECRUITING

Developing a Nationwide Registry to Track Longitudinal Clinical Outcomes of Corneal Surgery and Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Developing a Nationwide Registry to Track Longitudinal Clinical Outcomes of Corneal Surgery and Disease

Quick Facts

Study Start:2023-10-12
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06101017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * OCT
  3. * Corneal topography
  4. * Specular biomicroscopy
  5. * In vivo confocal biomicroscopy
  1. * Any criteria that does not meet the inclusion criteria above.

Contacts and Locations

Study Contact

Nitin G Vaswani, MD
CONTACT
7577263449
nitin@manoshealth.com
Priya M Mathews, MD
CONTACT
2404720391
priya.m.mathews@gmail.com

Principal Investigator

Priya M Mathews, MD
PRINCIPAL_INVESTIGATOR
Keratoplasty Alliance International
Nitin G Vaswani, MD
PRINCIPAL_INVESTIGATOR
Keratoplasty Alliance International

Study Locations (Sites)

Keratoplasty Alliance International
Baltimore, Maryland, 21210
United States

Collaborators and Investigators

Sponsor: Keratoplasty Alliance International

  • Priya M Mathews, MD, PRINCIPAL_INVESTIGATOR, Keratoplasty Alliance International
  • Nitin G Vaswani, MD, PRINCIPAL_INVESTIGATOR, Keratoplasty Alliance International

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-12
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2023-10-12
Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Corneal Disease
  • Endothelial Corneal Dystrophy
  • Corneal Transplant Failure
  • Corneal Transplant Rejection