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The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Control | Sham Comparator |
| |
| CXL Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEGA UV-A Illumination System | Device | Only subjects assigned to the treatment group will receive treatment with the UV Light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Corneal Curvature | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Phoenix | Arizona | United States | |||
| Woolfson Eye Institute |
Enrolled participants were excluded from the clinical trial because they failed to meet one or more the inclusion/exclusion criteria.
The recruitment period started December 2010 and ended June 2012 at medical clinics throughout the country.
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| ID | Title | Description |
|---|---|---|
| FG000 | CXL Treatment | VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light Riboflavin : Both treatment and sham groups will receive riboflavin |
| FG001 | Sham Control | Riboflavin : Both treatment and sham groups will receive riboflavin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CXL Treatment | VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light Riboflavin : Both treatment and sham groups will receive riboflavin |
| BG001 | Sham Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Corneal Curvature | The CXL-002 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study. | Posted | 6 Months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CXL Treatment | VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light Riboflavin : Both treatment and sham groups will receive riboflavin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bob Gibson | Topcon Medical Systems | (201) 599-5121 | RGIBSON@TOPCON.COM |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| 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 |
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| Riboflavin | Drug | Both treatment and sham groups will receive riboflavin |
|
| Atlanta |
| Georgia |
| United States |
| Minnesota Eye Consultants, P.A. | Bloomington | Minnesota | 55431 | United States |
| Laser and Corneal Surgery Assoc. PC | New York | New York | 10022 | United States |
| Mt. Sinai Hospital | New York | New York | United States |
| Pamel Vision & Laser Group | New York | New York | United States |
| Cleveland Clinic-Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| The Ohio State University College of Medicine | Columbus | Ohio | 43212 | United States |
| ReVision Advanced Laser Eye Center | Columbus | Ohio | 43240 | United States |
| Dell Laser Consultants | Austin | Texas | United States |
| Slade & Baker Vision | Houston | Texas | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
Riboflavin : Both treatment and sham groups will receive riboflavin
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Sham Control | Riboflavin : Both treatment and sham groups will receive riboflavin | 0 | 37 | 0 | 37 |
All such Confidential Information shall remain the property of Topcon, as applicable, and Institution agrees that neither it nor Principal Investigator nor any of its employees or Sub-Investigators, if any, shall disclose any of the Confidential Information to third parties, without the prior written consent of Topcon.
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |