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Clinical Trials/NCT02109848
NCT02109848
Completed
Not Applicable

Observational Study of Keratoconus and Post-keratoplasty Eyes

Oregon Health and Science University1 site in 1 country7 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratoconus and Post-keratoplasty
Sponsor
Oregon Health and Science University
Enrollment
7
Locations
1
Primary Endpoint
validate OCT anterior topography
Status
Completed
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Huang

: David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

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

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.

Outcomes

Primary Outcomes

validate OCT anterior topography

Time Frame: 3-4 month

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

Study Sites (1)

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