Recruiting

OCT

Sponsor:

Oregon Health and Science University

Code:

NCT03504800

Conditions

Keratoconus

Corneal Opacity

Corneal Dystrophy

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Accepted

Interventions

Optical Coherence Tomography

Study Details

Brief summary:

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.

Conditions

Keratoconus

Corneal Opacity

Corneal Dystrophy

Study ID

NCT03504800

Start date

May 1, 2018

Status verified date

Sep, 2025

Completion date

Feb 28, 2031

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

445 participants

Anticipated

Interventions and Outcome Measures

Arms

Group A: Classification of Corneal Irregularities

This group will consist of participants >14 years old with various types of corneal irregularities. Their data will be compared against participants with healthy corneas. Data for this group will be gathered only once.

Group B: Detection of Keratoconus Progression

Participants from Group A who are diagnosed with keratoconus will be selected for this longitudinal study to monitor keratoconus progression. They will be followed up to 4 years.

Group C: OCT-and-Topography Guided PTK

Participants from Group A will be selected for this group if they have vision primarily limited by scars, dystrophy, or high astigmatism that could be treated by PTK. They will be followed up to 1 year.

Interventions

Optical Coherence Tomography

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

Primary outcome measure

  • Develop OCT-based system to classify and evaluate corneal-shape irregularities [ Time Frame: 1 day ]
  • Develop OCT-based system to classify and evaluate corneal-shape irregularities [ Time Frame: 1 day ]
  • Develop OCT metrics for more sensitive detection of keratoconus progression [ Time Frame: 4 year ]
  • Develop OCT metrics for more sensitive detection of keratoconus progression [ Time Frame: 4 year ]
  • Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas [ Time Frame: 1 year ]
  • Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Humberto Martinez

Recruiting

Portland, Oregon, United States, 97239

Contacts

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • OCT
  • Keratoconus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-09-09.