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

Study Overview

• Status: Completed
• Conditions: Keratoconus and Post-keratoplasty

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute, Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Post Operative surgical patients at Oregon Health & Science University for keratoconus, keratoplasty, DSAEK

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
keratoconus
post-keratoplasty
post-DSAEK; Descemet's stripping automated endothelial keratoplasty (DSAEK)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Eye Institute (NEI); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: keratoconus; post-keratoplasty
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: OHSU IRB #00006612; R01EY018184 (U.S. NIH Grant/Contract)