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The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epi-On Continuous | Active Comparator | Continuous beam of UV light treating cornea with surface epithelium present |
|
| Epi-Off Continuous | Active Comparator | Continuous beam of UV light treating cornea without surface epithelium present |
|
| Epi-On Pulsed | Active Comparator | Pulsed beam of UV light treating cornea with surface epithelium present |
|
| Epi-Off Pulsed | Active Comparator | Pulsed beam of UV light treating cornea without surface epithelium present |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epithelium-On Riboflavin | Drug | Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Uncorrected visual acuity | 2 years |
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Inclusion Criteria Keratoconus:
12 years of age or older
Having a clinical diagnosis of progressive keratoconus consistent with:
Presence of central or inferior steepening on the topography map.
Axial topography consistent with keratoconus
Steepest keratometry (Kmax) value ≥ 47.00 D
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits
Contact lens removal prior to evaluation and treatment
Inclusion Criteria Post-Surgical Ectasia:
History of having undergone a keratorefractive procedure and:
At least two of the above criteria must be present.
Inclusion Criteria Intacts:
Should the patient have undergone prior Intacs or other intra-corneal ring segment surgery for keratoconus or post-surgical ectasia at least 6 months prior, and is also experiencing at least two of the above ectasia symptoms, they can be included in the study.
Should a patient's situation due to factors such as significantly high myopia or astigmatism should warrant simultaneous placement of Intacs and cross-linking in the investigators opinion, then this option can be offered to the patient. Such interventions would be tracked as a different arm of the study.
Inclusion Criteria RK/AK Fluctuation:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Travis A Johnson, Bachelor's | Contact | 571-234-5678 | 104 | tjohnson@libertylasereye.com |
| Nancy A Tanchel, MD | Contact | 571-234-5678 | 103 | ntanchel@libertylasereye.com |
| Name | Affiliation | Role |
|---|---|---|
| Nancy A Tanchel, MD | Liberty Laser Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LaserVue Eye | Santa Rosa | California | 95403 | United States |
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| Epithelium-Off Riboflavin | Drug | Riboflavin 0.1% Phosphate Sodium solution |
|
|
| UV Light - Continuous Beam | Device | 5 minutes of constant UV exposure to saturated cornea |
|
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| UV Pulsed Beam | Device | 5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes |
|
|
| Icon Lasik | Denver | Colorado | 80210 | United States |
|
| Gulani Vision Institute | Jacksonville | Florida | 32216 | United States |
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| Eye Consultants of Atlanta | Atlanta | Georgia | 30339 | United States |
|
| Midwest Center for Sight | Des Plaines | Illinois | 60016 | United States |
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| Bond Eye Associates | Pekin | Illinois | 61554 | United States |
|
| Discover Vision Center | Leawood | Kansas | 66211 | United States |
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| Southern Eye Center | Hattiesburg | Mississippi | 39402 | United States |
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| Mercy Clinic Eye Specialists | Springfield | Missouri | 65807 | United States |
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| LASIK of Nevada | Las Vegas | Nevada | 89123 | United States |
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| James Lewis MD PC | Elkins Park | Pennsylvania | 19027 | United States |
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| Memorial Eye Institute | Harrisburg | Pennsylvania | 17112 | United States |
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| Carolina Eye Care | Mt. Pleasant | South Carolina | 29464 | United States |
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| Loden Vision Centers | Goodlettsville | Tennessee | 37072 | United States |
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| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
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| Liberty Laser Eye Center | Vienna | Virginia | 22182 | United States |
|
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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