OCT in Diagnosis of Irregular Corneas

September 5, 2025 updated by: David Huang, Oregon Health and Science University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
445

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Humberto Martinez
        • Contact:
        • Sub-Investigator:
          • David Huang, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Winston Chamberlain, MD, PhD
        • Sub-Investigator:
          • Afshan Nanji, MD
        • Sub-Investigator:
          • Richard Stutzman, MD
        • Sub-Investigator:
          • Ellen Davis, MD
        • Sub-Investigator:
          • Seema Gupta, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 445 participants ages 14 or older will be recruited for the 3 clinical studies. All 3 studies will be performed at the Casey Eye Institute at Oregon Health & Science University.

Group A:

  • Keratoconus: 150 participants
  • Epithelial deformation: 105 participants; This category includes contact lens-related corneal warpage, dry eye, and EBMD.
  • Primary stromal changes: 100 participants; This category includes corneal scars, Salzmann's degeneration, stromal dystrophies, complicated LASIK/PRK cases with visual complaints, RK cases, and corneal transplants.
  • Healthy Controls: 90 participants

Description

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 (all groups):

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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.
Device: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Time Frame: 1 day
Clinical classification of keratoconus, epithelial deformation, stromal addition/subtraction, stromal distortion, and healthy controls by OCT. Primary measurements will be corneal and epithelial thicknesses assessed in micron units.
1 day
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Time Frame: 1 day
Secondary measurement will be OCT corneal shape assessed in Diopter units.
1 day
Develop OCT metrics for more sensitive detection of keratoconus progression
Time Frame: 4 year
Primary measurements will be OCT corneal and epithelial thicknesses assessed in micron units.
4 year
Develop OCT metrics for more sensitive detection of keratoconus progression
Time Frame: 4 year
Secondary measurement will be OCT corneal shape assessed in Diopter units.
4 year
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
Time Frame: 1 year
The primary goal is to improve the post-procedural outcome of uncorrected and best corrected visual acuity. This will be measured in feet by conventional Snellen fraction of 20/xx.
1 year
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
Time Frame: 1 year
The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yan Li, PhD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB#000018036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Opacity

Clinical Trials on Optical Coherence Tomography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings