Observational Study of Corneal Opacities in Adults

February 8, 2024 updated by: David Huang, Oregon Health and Science University
A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Humberto Martinez
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Huang, MD, PhD
        • Sub-Investigator:
          • Winston Chamberlain, MD, PhD
        • Sub-Investigator:
          • Afshan Nanji, MD
        • Sub-Investigator:
          • Richard Stutzman, MD
        • Sub-Investigator:
          • Yan Li, PhD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Description

Inclusion Criteria:

• Adult (18 & older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Exclusion Criteria:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging.
  • Inability to commit to required visits to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
corneal opacities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of suitable subjects
Time Frame: 2 years
The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate OCT topography
Time Frame: 2 years
A second goal is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography and develop a mathematical model that relates epithelial thickness variation to corneal mean curvature.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

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 Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimated)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU IRB#6612 - Opac
  • R01EY018184 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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