RECRUITING

OCT in Diagnosis of Irregular Corneas

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-05-01
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03504800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Keratoconus:
  2. 1. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
  3. 2. Topography characteristic of keratoconus or pellucid marginal degeneration
  4. * Contact lens-related corneal warpage:
  5. 1. Contact lens use; and
  6. 2. Topography irregularities
  7. * Dry eye:
  8. 1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
  9. 2. Topography irregularities
  10. 3. Presence of punctate epithelial erosion on exam with surface staining
  11. 4. Aqueous deficiency or evaporative dry eye
  12. * Epithelial basement membrane dystrophy (EBMD):
  13. 1. Negative corneal fluorescein staining; and
  14. 2. Corneal opacities; and
  15. 3. Topography irregularities
  16. * Stromal addition or subtraction:
  17. 1. Scars; or
  18. 2. Salzmann's degeneration; or
  19. 3. Stromal dystrophies; or
  20. 4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)
  21. * Stromal distortion:
  22. 1. Radial keratectomy (RK); or
  23. 2. Corneal transplants.
  24. * Normal controls:
  25. 1. Healthy eyes with no previous eye procedures/surgeries.
  26. * Inability to give informed consent.
  27. * Inability to maintain fixation for OCT imaging.
  28. * Inability to commit to required study visits.
  29. * Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
  30. * Previous corneal surgeries if considered as a keratoconus participant.
  31. * Pregnancy or breastfeeding.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Humberto Martinez, COT
CONTACT
503-494-7712
martinhu@ohsu.edu
Denny Romfh, OD
CONTACT
503-494-4351
romfhd@ohsu.edu

Principal Investigator

Yan Li, PhD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Humberto Martinez
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Yan Li, PhD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-01
Study Completion Date2026-04

Study Record Updates

Study Start Date2018-05-01
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • OCT
  • Keratoconus

Additional Relevant MeSH Terms

  • Keratoconus
  • Corneal Opacity
  • Corneal Dystrophy