Using OCT to Diagnose Irregular Corneas

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

This study is testing a new way using advanced imaging to better identify and track irregular corneas in people with conditions like keratoconus, to help improve their treatment.

Quick facts

• Study type: Observational
• Enrollment: 445 (estimated)
• Ages: 14 Years to 85 Years
• Sex: All
• Sponsor: Oregon Health and Science University (other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT03504800 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the detection, classification, monitoring, and treatment of irregular corneas associated with conditions like keratoconus and corneal dystrophies. It employs optical coherence tomography (OCT) to develop a system for classifying corneal shape irregularities and create metrics for more sensitive detection of keratoconus progression. Additionally, the study seeks to guide phototherapeutic keratectomy (PTK) using OCT and topography for patients with irregular corneas.

Who should consider this trial

Good fit: Ideal candidates include individuals with keratoconus, corneal warpage, dry eye, or other corneal irregularities.

Not a fit: Patients without any corneal irregularities or those with stable corneal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment options for patients with irregular corneas.

How similar studies have performed: Other studies utilizing OCT for corneal assessment have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Portland, Oregon

• Humberto Martinez — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Yan Li, PhD — Oregon Health and Science University
• Study coordinator: Humberto Martinez, COT

Conditions: Keratoconus, Corneal Opacity, Corneal Dystrophy, OCT