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This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in conjunction with the UVA light as a photosensitizer.
The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen cross-linking (performed using the PXL-Platinum 330 system) for treating corneal curvature and biomechanical anomalies associated with corneal thinning conditions, e.g., progressive or non-progressive keratoconus, pellucid marginal degeneration, and treatment of patients with bacterial or fungal keratitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed lighting | Other |
| |
| Continuous lighting | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed or continuous lighting | Combination Product | The cross-linking procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source and riboflavin solution). |
| Measure | Description | Time Frame |
|---|---|---|
| PXL-Platinum 330 system | Keratometry | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy measurements by best spectacle-corrected visual acuity | Percentage of eyes that had a BSCVA worse than 20/40 | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
Pregnancy (including plan to become pregnant) or lactation during the course of the study.
A known sensitivity to study medications.
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
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| Name | Affiliation | Role |
|---|---|---|
| Vishal Jhanji, MD | UPMC Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
In addition to UPMC having access to identifiable information, Peschke Meditrade of Switzerland will have access to de-identifiable information.
An indefinite period.
Deidentified individual participant data sets with other researchers outside of your study team.
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Prospective, double-arm, randomized single-site study
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Subjects will be assigned randomly to either pulsed or continuous lighting.
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |