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OCT in Diagnosis of Irregular Corneas | Clinical Trials | Clareo Health

RECRUITING

OCT in Diagnosis of Irregular Corneas

Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas

NCT03504800•Oregon Health and Science University

Summary

This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions. The primary goal will be achieved by using optical coherence tomography (OCT) to: 1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities. 2. Develop OCT metrics for more sensitive detection of keratoconus progression. 3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.

Eligibility

Age

14 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•GROUP A:
•Keratoconus:
•1. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
•2. Topography characteristic of keratoconus or pellucid marginal degeneration
•Contact lens-related corneal warpage:
•1. Contact lens use; and
•2. Topography irregularities
•Dry eye:
•1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
•2. Topography irregularities
+20 more criteria

Exclusion Criteria

•Inability to give informed consent.
•Inability to maintain fixation for OCT imaging.
•Inability to commit to required study visits.
•Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
•Previous corneal surgeries if considered as a keratoconus participant.
•Pregnancy or breastfeeding.

Locations (1)

Humberto Martinez

Portland, Oregon, United States

Key Dates

Start Date

May 1, 2018

Primary Completion Date

February 28, 2030

Completion Date

February 28, 2031

Last Updated

September 9, 2025

Enrollment

445

ESTIMATED participants

Conditions

KeratoconusCorneal OpacityCorneal Dystrophy

Interventions

Optical Coherence Tomography

DEVICE

Contacts

Humberto Martinez, COT

CONTACT

503-494-7712 martinhu@ohsu.edu

Denny Romfh, OD

CONTACT

503-494-4351 romfhd@ohsu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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OCT in Diagnosis of Irregular Corneas

Inclusion Criteria

Exclusion Criteria

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