Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
Study Details
Study Description
Brief Summary
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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, pachymetry, and visual function questionnaire.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pulsed, accelerated 4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Other Names:
|
| Experimental: Pusled, accelerated 8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution |
Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Best-contact corrected visual acuity (BSCVA) [3, 6, and 12 months]
Change in BSCVA compared to baseline.
Secondary Outcome Measures
- Uncorrected visual acuity [3, 6, and 12 months]
Change in UCVA compared to baseline.
- Keratometry [1 year]
Change in Kmax, compared to baseline.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:
1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
-
Fleischer ring
-
Vogt's striae
-
Decentered corneal apex
-
Munson's sign
-
Apical Corneal scarring consistent with Bowman's breaks
-
Scissoring of the retinoscopic reflex
-
Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference > 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation >16 microns 8. Thinnest corneal point >300 microns 9. Contact Lens
Wearers Only:
- Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft or Scleral 3 days Rigid gas permeable 2 weeks
Exclusion Criteria:
All subjects meeting any of the following criteria will be excluded from this study:
-
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:
-
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
-
Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Goodman Eye Center | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- Goodman Eye Center
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- PXL-2211