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OpenTrials
Completed

NCT Number: NCT02109848

Observational Study of Keratoconus and Post-keratoplasty Eyes

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Eye Institute (NEI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2014
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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