Observational Study of Keratoconus and Post-keratoplasty Eyes

Completed

• Conditions: Keratoconus and Post-keratoplasty

• Registration Number: NCT02109848
• Lead Sponsor: Oregon Health and Science University

Brief Summary

A prospective observational study on keratoconus and post-keratoplasty will be conducted. We will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans will be used to 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 imagery, will be performed for comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze formation.107, 108 In these cases PRK will be performed according to the standard of care and will not be a part of the study protocol. The postoperative results will be observed at the 3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography, ultrasound pachymetry, and Scheimpflug camera imagery

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
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Adults (18 & older) with keratoconus, keratoplasty, DSAEK procedures

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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
validate OCT anterior topography	3-4 month	The primary goal of this observational study is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography

Trial Locations

Locations (1)

Casey Eye Institute, Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States