Observational Study of Corneal Opacities in Adults

NCT ID: NCT02109471

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Opacities (Scar and Stromal Dystrophy)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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corneal opacities

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Humberto Martinez

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Humberto Martinez, COT

Role: CONTACT

503-494-7712

Denzil Romfh, OD

Role: CONTACT

503-494-4351

Facility Contacts

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Humberto Martinez, COT

Role: primary

503-494-7712

Denzil Romfh, OD

Role: backup

503-494-4351

Other Identifiers

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R01EY018184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU IRB#6612 - Opac

Identifier Type: -

Identifier Source: org_study_id

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