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Clinical Trials/NCT03504800
NCT03504800
Recruiting
Not Applicable

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

Oregon Health and Science University1 site in 1 country445 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratoconus
Sponsor
Oregon Health and Science University
Enrollment
445
Locations
1
Primary Endpoint
Develop OCT metrics for more sensitive detection of keratoconus progression
Status
Recruiting
Last Updated
7 months ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
February 28, 2031
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Huang

Yan Li, PhD, Assistant Professor of Ophthalmology

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Keratoconus:
  • CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
  • Topography characteristic of keratoconus or pellucid marginal degeneration
  • Contact lens-related corneal warpage:
  • Contact lens use; and
  • Topography irregularities
  • Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
  • Topography irregularities
  • Presence of punctate epithelial erosion on exam with surface staining
  • Aqueous deficiency or evaporative dry eye

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Develop OCT metrics for more sensitive detection of keratoconus progression

Time Frame: 4 year

Secondary measurement will be OCT corneal shape assessed in Diopter units.

Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas

Time Frame: 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

Time Frame: 1 day

Secondary measurement will be OCT corneal shape assessed in Diopter units.

Study Sites (1)

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