OCT in Diagnosis of Irregular Corneas

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504800
• Other study ID #: IRB#000018036
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Humberto Martinez, COT
• Phone: 503-494-7712
• Email: martinhu[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 445
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Corneal Dystrophy
• Corneal Opacity
• Keratoconus

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Humberto Martinez	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

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