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Investigator no longer at university
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Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.
After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham treatment | Sham Comparator | Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit. |
|
| Treatment Arm | Active Comparator | After randomization, the active arm will have the collagen crosslinking intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin | Drug | 01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in keratometry | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| best spectacle-corrected visual acuity | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Keates, MD | The Ohio State Univesity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States | ||
| OSU Havener Eye Institute |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| D003316 | Corneal Diseases |
| 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 |
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|
| Placebo | Drug | Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs. |
|
| Dublin |
| Ohio |
| 43016 |
| United States |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |