OCT in Diagnosis of Irregular Corneas

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Corneal Opacity; Keratoconus; Corneal Dystrophy

Treatments: Device: Optical Coherence Tomography

Study type: Observational

Funder types: Other

Identifiers

NCT03504800

IRB#000018036

Details and patient eligibility

About

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.

Enrollment: 445 estimated patients

Sex: All

Ages: 14 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

445 participants in 3 patient groups

Group A: Classification of Corneal Irregularities

Description:

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.

Treatment:

Device: Optical Coherence Tomography

Group B: Detection of Keratoconus Progression

Description:

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.

Treatment:

Device: Optical Coherence Tomography

Group C: OCT-and-Topography Guided PTK

Description:

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.

Treatment:

Device: Optical Coherence Tomography