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| Name | Class |
|---|---|
| CooperVision, Inc. | INDUSTRY |
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As new orthokeratology fitting software emerges onto the market, it is of interest to assess their usefulness in guiding eye practitioners with lens fit. The goal of this study is to evaluate the comfort of Paragon orthokeratology lenses when they are fit using the new Procornea software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control contact lens | Device | control CRT lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses | 1 week |
| Comfort | Comfort of lenses (VAS 0-10, 0,5 steps) after insertion, subjects will be graded on a scale from 0 to 10 with 0=painful, 10= can't feel the lenses | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Present at screening visit with the presence of ocular or systemic disease or reports the use medications which might interfere with orthokeratology contact lens wear, such as keratoconus, diabetes mellitus, steroid eye drops
Have a post-treatment predicted flat K value ≤38.00D (e.g. Patient baseline flat keratometry value = 40.00, patient has 2.00D of myopic refractive error. 40.00-2.00= 38.00D)
Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study
Are pregnant, planning a pregnancy or lactating
Have amblyopia
Have presbyopia or has dependence on spectacles for near work over the contact lenses
Present at screening visit with the presence of clinically significant (grade >3; Efron scale) anterior segment abnormalities.
Present at screening visit with slit lamp findings that would contraindicate orthokeratology contact lens wear such as:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, OD | Contact | 925-621-3761 | jvega2@coopervision.com | |
| Kelly Voltz, OD | Contact | kvoltz@coopervisionsec.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4S Eyecare and Optometry | Recruiting | San Diego | California | 92127 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Carillon Vision Care | Recruiting | Glenview | Illinois | 60025 | United States |
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| Bellaire Family EyeCare | Recruiting | Bellaire | Texas | 77401 | United States |
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| University Complutense of Madrid | Not yet recruiting | Madrid | Spain |
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