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To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and pachymetry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed, Accelerated | Experimental | 5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
|
| Conventional | Active Comparator | 4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXL-330 Platinum device for crosslinking with Peschke riboflavin solution | Combination Product | Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected distance visual acuity | Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected visual acuity | Change in UCVA at 6 months, compared to baseline. | 6 months |
| Keratometry | Change in Kmax, compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivam Patel, BS | Contact | 720-709-7523 | spatel@corneaonline.com | |
| Wendy Bigger | Contact | 720-709-7533 | wbigger@corneaonline.com |
| Name | Affiliation | Role |
|---|---|---|
| S. Lance Forstot, M.D. | Colorado Eye Consultants/Corneal Consultants of Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Eye Consultants/Corneal Consultants of Colorado | Recruiting | Littleton | Colorado | 80120 | United States |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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|
| 12 months |
| Chicago Cornea Consultants, Ltd. | Active, not recruiting | Highland Park | Illinois | 60035 | United States |
| Cleveland Eye Clinic | Recruiting | Brecksville | Ohio | 44141 | United States |
|
| D010789 |
| Phototherapy |