OCT in Diagnosis of Irregular Corneas

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: Recruiting
• Conditions: Corneal Opacity; Keratoconus; Corneal Dystrophy
• Intervention / Treatment: Device: Optical Coherence Tomography

• Study Type: Observational
• Enrollment (Estimated): 445

Contacts and Locations

• Study Contact: Name: Denny Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu
• Study Contact Backup: Name: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Humberto Martinez
      • Contact: Denny Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu
      • Sub-Investigator: David Huang, MD, PhD
      • Contact: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
      • 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Develop OCT-based system to classify and evaluate corneal-shape irregularities	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	Secondary measurement will be OCT corneal shape assessed in Diopter units.	1 day
Develop OCT metrics for more sensitive detection of keratoconus progression	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	Secondary measurement will be OCT corneal shape assessed in Diopter units.	4 year
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas	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	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

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Yan Li, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2031

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: OCT; Keratoconus
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Corneal Diseases; Eye Diseases, Hereditary; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratoconus; Corneal Dystrophies, Hereditary; Corneal Opacity; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID 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