OCT in Diagnosis of Irregular Corneas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-85
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 use; and
Topography irregularities
Disqualifiers
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.
Trial population
A total of 445 participants ages 14 or older will be recruited for the 3 clinical studies. All 3 studies will be performed at the Casey Eye Institute at Oregon Health \& Science University. Group A: * Keratoconus: 150 participants * Epithelial deformation: 105 participants; This category includes contact lens-related corneal warpage, dry eye, and EBMD. * Primary stromal changes: 100 participants; This category includes corneal scars, Salzmann's degeneration, stromal dystrophies, complicated LASIK/PRK cases with visual complaints, RK cases, and corneal transplants. * Healthy Controls: 90 participants
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Optical Coherence Tomography
DeviceThis device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \& C.
Treatment groups
445 Participants
are divided into 3 treatment groupsGroup A: Group A: Classification of Corneal Irregularities1 intervention
Group B: Group B: Detection of Keratoconus Progression1 intervention
Group C: Group C: OCT-and-Topography Guided PTK1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 day2
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Time frame
1 day3
Develop OCT metrics for more sensitive detection of keratoconus progression
Primary measurements will be OCT corneal and epithelial thicknesses assessed in micron units.
Time frame
4 year4
Develop OCT metrics for more sensitive detection of keratoconus progression
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Time frame
4 yearSponsors and contacts
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Source ClinicalTrials.gov