Using OCT to Diagnose Irregular Corneas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Humberto Martinez
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Yan Li, PhD — Oregon Health and Science University
• Study coordinator: Humberto Martinez, COT
• Email: martinhu@ohsu.edu
• Phone: 503-494-7712

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GLK-221 eye drops for keratoconus

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  Recruiting Phase 2 Glaukos Corporation · Westerville, Ohio · NCT07400952

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.