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NCT Number: NCT03504800

OCT in Diagnosis of Irregular Corneas

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.

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Key information

Conditions

Keratoconus Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Dystrophy Corneal Opacity Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Humberto Martinez

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Afshan Nanji, MD

SUB_INVESTIGATOR

David Huang, MD, PhD

SUB_INVESTIGATOR

Denny Romfh, OD

CONTACT

[email protected]

503-494-4351

Ellen Davis, MD

SUB_INVESTIGATOR

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Richard Stutzman, MD

SUB_INVESTIGATOR

Seema Gupta, MD

SUB_INVESTIGATOR

Winston Chamberlain, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

GROUP A:

  • Keratoconus:
  • CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
  • Topography characteristic of keratoconus or pellucid marginal degeneration
  • Contact lens-related corneal warpage:
  • Contact lens use; and
  • Topography irregularities
  • Dry eye:
  • Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
  • Topography irregularities
  • Presence of punctate epithelial erosion on exam with surface staining
  • Aqueous deficiency or evaporative dry eye
  • Epithelial basement membrane dystrophy (EBMD):
  • Negative corneal fluorescein staining; and
  • Corneal opacities; and
  • Topography irregularities
  • Stromal addition or subtraction:
  • Scars; or
  • Salzmann's degeneration; or
  • Stromal dystrophies; or
  • Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)
  • Stromal distortion:
  • Radial keratectomy (RK); or
  • Corneal transplants.
  • Normal controls:
  • 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.

Treatment and study plan

optical coherence tomography

Device

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

Primary outcomes

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

    Time frame: 1 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.

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

    Time frame: 1 day

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

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

    Time frame: 4 year

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

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

    Time frame: 4 year

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

  5. Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas

    Time frame: 1 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.

  6. Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Denny Romfh, OD

CONTACT

[email protected]

503-494-4351

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2030
Study completion
2031
First posted
Apr 20, 2018
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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