Observational Study on OCT for Irregular Corneas

This study aims to improve how doctors detect, classify, monitor, and treat irregular corneas, which are problems with the clear front part of your eye. This includes conditions like keratoconus (a thinning of the cornea), corneal warpage from contact lenses, and dry eye. Researchers will use a device called Optical Coherence Tomography (OCT) to better understand these conditions. The main goals are to develop a system using OCT to classify corneal irregularities, find better ways to track the progression of keratoconus, and improve a laser treatment called phototherapeutic keratectomy (PTK) for irregular corneas. You might be able to join if you are between 14 and 85 years old and have certain eye conditions like keratoconus or contact lens-related corneal warpage.

Study design
This is an observational study planning to include 445 participants. It uses the Optical Coherence Tomography (OCT) device to classify corneal irregularities.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study aims to develop tools for detecting keratoconus progression over 4 years.

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NCT03504800

OCT in Diagnosis of Irregular Corneas

Recruiting
Not specifiedAges 14–85Observational
Oregon Health and Science University
~445 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Optical Coherence Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Measured over 1 day
+5 more outcomes measured
Keratoconus
Corneal Opacity
Corneal Dystrophy
1 sites across 1 states
Oregon1
  • Yan Li, PhD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

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Eligibility criteria

Inclusion

Keratoconus:
Contact lens-related corneal warpage:
Dry eye:
Epithelial basement membrane dystrophy (EBMD):
Stromal addition or subtraction:
Stromal distortion:
Normal controls:

Exclusion

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.
  • Develop OCT-based system to classify and evaluate corneal-shape irregularities1 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.

  • Develop OCT-based system to classify and evaluate corneal-shape irregularities1 day

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

  • Develop OCT metrics for more sensitive detection of keratoconus progression4 year

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

  • Develop OCT metrics for more sensitive detection of keratoconus progression4 year

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

  • Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas1 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.

  • Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas1 year

    The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.