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Observational Study of Corneal Opacities in Adults

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ClinicalTrials.gov Identifier: NCT02109471
Recruitment Status : Recruiting
First Posted : April 10, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief Summary:
A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and 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 imaging, will be performed for comparison.

Condition or disease
Corneal Opacities (Scar and Stromal Dystrophy)

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Corneal Opacities in Adults
Study Start Date : June 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort
corneal opacities



Primary Outcome Measures :
  1. Identification of suitable subjects [ Time Frame: 2 years ]
    The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK.


Secondary Outcome Measures :
  1. Validate OCT topography [ Time Frame: 2 years ]
    A second goal is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography and develop a mathematical model that relates epithelial thickness variation to corneal mean curvature.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)
Criteria

Inclusion Criteria:

• Adult (18 & older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109471


Contacts
Contact: Omkar Thaware, B Optom, MSVS 503-494-7398 thaware@ohsu.edu
Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu

Locations
United States, Oregon
Casey Eye Institute, Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Omkar Thaware, B Optom, MSVS    503-494-7398    thaware@ohsu.edu   
Contact: Denzil Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Principal Investigator: David Huang, MD, PhD         
Sub-Investigator: Winston Chamberlain, MD, PhD         
Sub-Investigator: Afshan Nanji, MD         
Sub-Investigator: John Clements, MD         
Sub-Investigator: Maolong Tang, PhD         
Sub-Investigator: Yan Li, PhD         
Sub-Investigator: Xinbo Zhang, PhD         
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
Principal Investigator: David Huang, MD, PhD Oregon Health and Science University

Responsible Party: David Huang, David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02109471     History of Changes
Other Study ID Numbers: OHSU IRB#6612 - Opac
R01EY018184 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by David Huang, Oregon Health and Science University:
corneal opacities
Optical coherence tomography

Additional relevant MeSH terms:
Corneal Opacity
Corneal Diseases
Eye Diseases