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The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theralight crosslinking and Riboflavin | Other | ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theralight crosslinking and Riboflavin | Other | Corneal Collagen cross linking with UV light and riboflavin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Spectacle Corrected Visual Acuity (BSCVA) | 6-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Uncorrected Visual Acuity (UCVA) | 6-9 months | |
| Change in Corneal topography | 6-9 months | |
| Change in Manifest Refraction |
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Inclusion Criteria:
8 years of age or older
Having at least one of the following conditions:
Signed written informed consent and/or assent
Likely to complete all study visits
Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Trattler, MD | Cxlusa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Excellence in Eye Care | Miami | Florida | 33176 | United States | ||
| Stulting Research Center at Woolfson Eye Institute |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 6-9 months |
| Change in Keratometry on topography and Pentacam | 6-9 months |
| Change in Wavefront Refraction and aberrations | 6-9 months |
| Atlanta |
| Georgia |
| 30328 |
| United States |
| TLC Laser Eye Center | Rockville | Maryland | 20852 | United States |
| Talamo Hatch Laser Eye Consultants, LLC | Boston | Massachusetts | 02451 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| TLC Laser Eye Center | Fairfax | Virginia | 22031 | United States |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |