Keratoconus and Post-keratoplasty Clinical Trial
Official title:
Observational Study of Keratoconus and Post-keratoplasty Eyes
| Verified date | April 2018 |
| Source | Oregon Health and Science University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 7 |
| Est. completion date | August 31, 2017 |
| Est. primary completion date | August 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Casey Eye Institute, Oregon Health & Science University | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Oregon Health and Science University | National Eye Institute (NEI), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |