OCT in Diagnosis of Irregular Corneas

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT03504800
Status
Recruiting
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Conditions

  • Corneal Dystrophy
  • Corneal Opacity
  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
14 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Sep 2025
Primary completion
Feb 28, 2030
Completion
Feb 28, 2031

Study Design

Enrollment
445 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Develop OCT-based system to classify and evaluate corneal-shape irregularities [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Humberto MartinezPortlandOregon97239
Humberto Martinez, COT
[email protected]
503-494-7712
Denny Romfh, OD
[email protected]
503-494-4351
David Huang, MD, PhD (SUB_INVESTIGATOR)
Winston Chamberlain, MD, PhD (SUB_INVESTIGATOR)
Richard Stutzman, MD (SUB_INVESTIGATOR)
Afshan Nanji, MD (SUB_INVESTIGATOR)
Ellen Davis, MD (SUB_INVESTIGATOR)
Seema Gupta, MD (SUB_INVESTIGATOR)

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