Observational Study of Keratoconus and Post-keratoplasty Eyes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02109848

Enrollment

Registered

2014-04-10

Start date

2011-06-30

Completion date

2017-08-31

Last updated

2018-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus and Post-keratoplasty

Keywords

keratoconus, post-keratoplasty

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results