Observational Study of Keratoconus and Post-keratoplasty Eyes

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconus and Post-keratoplasty

Study Design

Study Type:

Observational

Actual Enrollment :

7 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study of Keratoconus and Post-keratoplasty Eyes

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Aug 31, 2017

Actual Study Completion Date :

Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
keratoconus
post-keratoplasty
post-DSAEK Descemet's stripping automated endothelial keratoplasty (DSAEK)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casey Eye Institute, Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University
National Eye Institute (NEI)
National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02109848

Other Study ID Numbers:

OHSU IRB #00006612
R01EY018184

First Posted:

Apr 10, 2014

Last Update Posted:

Apr 6, 2018

Last Verified:

Apr 1, 2018

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

keratoconus

post-keratoplasty

Additional relevant MeSH terms:

Keratoconus

Study Results

No Results Posted as of Apr 6, 2018