OCT in Diagnosis of Irregular Corneas

NCT03504800 | Recruiting FDA Device

• 1 other identifier: IRB#000018036
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

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. 1.Develop an OCT-based system to classify and evaluate corneal-shape irregularities.
2. 2.Develop OCT metrics for more sensitive detection of keratoconus progression.
3. 3.Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.

Conditions

Keratoconus; Corneal Opacity; Corneal Dystrophy

Keywords

OCT; Keratoconus

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

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

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

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

Interventions

Optical Coherence Tomography DEVICE

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

Group A: Classification of Corneal Irregularities; Group B: Detection of Keratoconus Progression; Group C: OCT-and-Topography Guided PTK

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• GROUP A:
• Keratoconus:
• CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
• Topography characteristic of keratoconus or pellucid marginal degeneration
• Contact lens-related corneal warpage:
• Contact lens use; and
• Topography irregularities
• Dry eye:
• Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
• Topography irregularities
• Presence of punctate epithelial erosion on exam with surface staining
• Aqueous deficiency or evaporative dry eye
• Epithelial basement membrane dystrophy (EBMD):
• Negative corneal fluorescein staining; and
• Corneal opacities; and

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Humberto Martinez

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus; Corneal Opacity; Corneal Dystrophies, Hereditary

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Yan Li, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Humberto Martinez, COT

CONTACT

503-494-7712; martinhu@ohsu.edu

Denny Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yan Li, PhD, Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 20, 2018
• Study Start: May 1, 2018
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2031
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)