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RecruitingNCT03504800Updated Sep 9, 2025

OCT in Diagnosis of Irregular Corneas

An observational study in Keratoconus, Corneal Opacity and Corneal Dystrophy, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 14 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Oregon Health and Science University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
445
Ages
14 Years to 85 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Keratoconus
  • Corneal Opacity
  • Corneal Dystrophy

Keywords

  • OCT
  • Keratoconus
03

Who can participate

Ages eligible
14 Years to 85 Years
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
445 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceOptical Coherence Tomography

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. Develop OCT-based system to classify and evaluate corneal-shape irregularities

    Secondary measurement will be OCT corneal shape assessed in Diopter units.

    Time frame: 1 day

  3. Develop OCT metrics for more sensitive detection of keratoconus progression

    Primary measurements will be OCT corneal and epithelial thicknesses assessed in micron units.

    Time frame: 4 year

  4. Develop OCT metrics for more sensitive detection of keratoconus progression

    Secondary measurement will be OCT corneal shape assessed in Diopter units.

    Time frame: 4 year

  5. 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.

    Time frame: 1 year

  6. 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.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Humberto Martinez
    Portland, Oregon 97239, United States
    • Humberto Martinez, COT · Contact · martinhu@ohsu.edu · 503-494-7712
    • Denny Romfh, OD · Contact · romfhd@ohsu.edu · 503-494-4351
    • David Huang, MD, PhD · Sub investigator
    • Winston Chamberlain, MD, PhD · Sub investigator
    • Richard Stutzman, MD · Sub investigator
    • Afshan Nanji, MD · Sub investigator
    • Ellen Davis, MD · Sub investigator
    • Seema Gupta, MD · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03504800
Lead sponsor
Oregon Health and Science University
Responsible party
David Huang (Yan Li, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University) — Principal investigator
First posted
Apr 20, 2018
Start date
May 1, 2018
Primary completion
Feb 28, 2030 (estimated)
Completion
Feb 28, 2031 (estimated)
Last update
Sep 9, 2025

Study contacts

Humberto Martinez, COT
Contact
martinhu@ohsu.edu
503-494-7712
Denny Romfh, OD
Contact
romfhd@ohsu.edu
503-494-4351
Yan Li, PhD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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