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This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.
This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corneal collagen cross-linking with riboflavin and UVA light | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal collagen cross-linking with riboflavin/UVA light | Other | Corneal collagen cross-linking with riboflavin/UVA light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in keratometry | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in manifest refraction spherical equivalent | 3 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin D. Stahl, MD | Contact | 816-234-3046 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 65108 | United States |
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| 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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