Observational Study of Corneal Opacities in Adults

Recruiting

• Conditions: Corneal Opacities (Scar and Stromal Dystrophy)

• Registration Number: NCT02109471
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of suitable subjects	2 years	The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK.

Secondary Outcome Measures

Name	Time	Method
Validate OCT topography	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.

Trial Locations

Locations (1)

Humberto Martinez; 🇺🇸 Portland, Oregon, United States