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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Develop OCT-based system to classify and evaluate corneal-shape irregularities | Secondary measurement will be OCT corneal shape assessed in Diopter units. | 1 day |
| 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 |
| Develop OCT metrics for more sensitive detection of keratoconus progression | Secondary measurement will be OCT corneal shape assessed in Diopter units. | 4 year |
| 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 |
| 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 |
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Inclusion Criteria:
GROUP A:
Keratoconus:
Contact lens-related corneal warpage:
Dry eye:
Epithelial basement membrane dystrophy (EBMD):
Stromal addition or subtraction:
Stromal distortion:
Normal controls:
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):
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Humberto Martinez, COT | Contact | 503-494-7712 | martinhu@ohsu.edu | |
| Denny Romfh, OD | Contact | 503-494-4351 | romfhd@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yan Li, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humberto Martinez | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D003318 | Corneal Opacity |
| D003317 | Corneal Dystrophies, Hereditary |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |