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

NCT06101017 | Completed

• 1 other identifier: MS.0823.001
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corneal Disease; Endothelial Corneal Dystrophy; Corneal Transplant Failure; Corneal Transplant Rejection

Outcome Measures

Primary Outcomes (3)

• Corneal thickness measurement from OCT images

  Measurements of individual corneal layers including the epithelium, Bowman's layer, stroma, Descemet's membrane, and endothelium. Overall corneal thickness from anterior to posterior surface.

  1 year

• Reflectivity measurement from OCT images

  Reflectivity profile within different layers of the cornea, including signal-to-noise ratio

  1 year

• Segmentation measurement from OCT images

  Identify boundaries of various corneal or retinal layers

  1 year

Secondary Outcomes (5)

• Corneal curvature measurement from Pentacam images

  1 year

• Corneal diameter measurement from Pentacam images

  1 year

• Corneal volume measurement from Pentacam images

  1 year

• Corneal cross-section identification from Pentacam images

  1 year

• Corneal densitometry measurement from Pentacam images

  1 year

Interventions

Optical Coherence Tomography DIAGNOSTIC_TEST

Non-invasive imaging test that use light waves to take cross-section pictures of the eye.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18+) with corneal disease and have received and OCT or Pentacam scan

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

Sponsors & Collaborators

• Nitin Vaswani: lead

Study Sites (1)

Keratoplasty Alliance International

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Conditions

Corneal Diseases; Corneal endothelial dystrophy type 2

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Priya M Mathews, MD

  Keratoplasty Alliance International

  PRINCIPAL INVESTIGATOR

• Nitin G Vaswani, MD

  Keratoplasty Alliance International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: October 12, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)