OCT in Diagnosis of Irregular Corneas

NCT ID: NCT03504800

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 445 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2031-02-28

Brief 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.

Conditions

Keratoconus; Corneal Opacity; Corneal Dystrophy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A: Classification of Corneal Irregularities

This group will consist of participants \>14 years old with various types of corneal irregularities. Their data will be compared against participants with healthy corneas. Data for this group will be gathered only once.

Optical Coherence Tomography

Intervention Type: DEVICE

This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.

Group B: Detection of Keratoconus Progression

Participants from Group A who are diagnosed with keratoconus will be selected for this longitudinal study to monitor keratoconus progression. They will be followed up to 4 years.

Optical Coherence Tomography

Intervention Type: DEVICE

This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.

Group C: OCT-and-Topography Guided PTK

Participants from Group A will be selected for this group if they have vision primarily limited by scars, dystrophy, or high astigmatism that could be treated by PTK. They will be followed up to 1 year.

Optical Coherence Tomography

Intervention Type: DEVICE

This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.

Interventions

Optical Coherence Tomography

This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.

Intervention Type: DEVICE

Eligibility Criteria

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

3. Presence of punctate epithelial erosion on exam with surface staining

4. Aqueous deficiency or evaporative dry eye

• Epithelial basement membrane dystrophy (EBMD):

1. Negative corneal fluorescein staining; and

2. Corneal opacities; and

3. Topography irregularities

• Stromal addition or subtraction:

1. Scars; or

2. Salzmann's degeneration; or

3. Stromal dystrophies; or

4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)

• Stromal distortion:

1. Radial keratectomy (RK); or

2. Corneal transplants.

• Normal controls:

1. Healthy eyes with no previous eye procedures/surgeries.

GROUP B:

Participants will be selected from the keratoconus population in Group A based on topography findings.

GROUP C:

Participants will be selected from the stromal addition/subtraction and stromal distortion populations of Group A if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from PTK.

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

Yan Li, PhD, Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Humberto Martinez

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Humberto Martinez, COT

Role: CONTACT

martinhu@ohsu.edu

503-494-7712

Denny Romfh, OD

Role: CONTACT

romfhd@ohsu.edu

503-494-4351

Facility Contacts

Humberto Martinez, COT

Role: primary

martinhu@ohsu.edu

503-494-7712

Denny Romfh, OD

Role: backup

romfhd@ohsu.edu

503-494-4351

Other Identifiers

IRB#000018036

Identifier Type: -

Identifier Source: org_study_id