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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02109471
Other study ID # OHSU IRB#6612 - Opac
Secondary ID R01EY018184
Status Recruiting
Phase
First received
Last updated
Start date June 2011
Est. completion date December 2025

Study information

Verified date February 2024
Source Oregon Health and Science University
Contact Humberto Martinez, COT
Phone 503-494-7712
Email martinhu@ohsu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Humberto Martinez Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of suitable subjects The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK. 2 years
Secondary Validate OCT topography 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