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This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low risk subjects for developing post-operative ectasia | Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia |
| |
| Subjects at Risk for Ectasia | Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal Cross-Linking | Device | Corneal cross-linking procedure conducted during vision correction surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Best-Corrected Visual Acuity | Month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Refractive error at the 1, 3 and 6 month visits | Months 1, 3, and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| William Trattler, MD | Center For Excellence In Eye Care | Study Director |
| Roy Rubinfeld | CXL-USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States | ||
| Clear View Eye & Laser Medical Center |
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| Riboflavin | Drug | Riboflavin will be instilled prior to corneal cross linking. |
|
| San Diego |
| California |
| United States |
| The Center for Excellence in Eye Care | Miami | Florida | United States |
| TLC Laser Eye Center | Rockville | Maryland | 20852 | United States |
| Talamo Laser Eye Center | Waltham | Massachusetts | United States |
| Minnesota Eye Consultants | Minneapolis | Minnesota | United States |
| Cleveland Eye Clinic | Breckville | Ohio | United States |
| TLC Laser Eye Center | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
| 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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