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The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.
Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXL Group | Patients with corneal ectasia following refractive surgery who had corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal Collagen Cross-linking | Combination Product | Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation). |
| Measure | Description | Time Frame |
|---|---|---|
| Kmax | Change from pretreatment baseline in maximum corneal curvature | 36 months |
| BCVA | Change from pretreatment baseline in BCVA | 36 month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with corneal ectasia following refractive surgery who are planning to undergo or have undergone corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerry Stephens, OD | Contact | 949-481-8057 | kstephens@glaukos.com |
| Name | Affiliation | Role |
|---|---|---|
| Kerry Stephens | Glaukos Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Recruiting | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28655538 | Background | Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484. doi: 10.1016/j.ophtha.2017.05.036. Epub 2017 Jun 24. |
| Label | URL |
|---|---|
| U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery | View source |
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| Chu Vision Institute, P.A. | Recruiting | Bloomington | Minnesota | 55420 | United States |
|
| Vance Thompson Vision - MT | Recruiting | Bozeman | Montana | 59718 | United States |
|
| Vance Thompson Vision - ND | Recruiting | West Fargo | North Dakota | 58078 | United States |
|
| Comprehensive EyeCare of Central Ohio | Recruiting | Westerville | Ohio | 43082 | United States |
|
| Vantage Eye Care, LLC | Recruiting | Bala-Cynwyd | Pennsylvania | 19004 | United States |
|
| Carolina Cataract & Laser Center | Recruiting | Ladson | South Carolina | 29456 | United States |
|
| Slade & Baker Vision | Recruiting | Houston | Texas | 77027 | United States |
|
| Hoopes Vision | Recruiting | Draper | Utah | 84020 | United States |
|
| See Clearly Vision Group | Recruiting | McLean | Virginia | 22102 | United States |
|
| Northwest Eye Surgeons | Recruiting | Seattle | Washington | 98133 | United States |
|
| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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