OCT in Diagnosis of Irregular Corneas

Recruiting

• Conditions: Keratoconus; Corneal Opacity; Corneal Dystrophy
• Interventions: Device: Optical Coherence Tomography

• Registration Number: NCT03504800
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Study Start: 2018-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 445

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B: Detection of Keratoconus Progression	Optical Coherence Tomography	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	Optical Coherence Tomography	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.
Group A: Classification of Corneal Irregularities	Optical Coherence Tomography	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.

Primary Outcome Measures

Name	Time	Method
Develop OCT metrics for more sensitive detection of keratoconus progression	4 year	Secondary measurement will be OCT corneal shape assessed in Diopter units.
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas	1 year	The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.
Develop OCT-based system to classify and evaluate corneal-shape irregularities	1 day	Secondary measurement will be OCT corneal shape assessed in Diopter units.

Trial Locations

Locations (1)

Humberto Martinez; 🇺🇸 Portland, Oregon, United States