Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Keratoconus Clinical Trial

Official title:

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04667572
• Other study ID #: PXL-330-CAT-2
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: Cornea Associates of Texas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

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, pachymetry, and visual function.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• 8 years of age or older

• Signed written informed consent

• Willingness and ability to comply with schedule for follow-up visits

• Contact Lens Wearers Only:

• Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)

And one or more of the following:

• Presence of central or inferior steepening.

• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

• 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, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography

• Steepest keratometry (Kmax) value = 47.20 D

• I-S keratometry difference > 1.5 D on the Pentacam/Orbscan map or topography map

• Posterior corneal elevation >16 microns

• Thinnest corneal point >300 microns

Exclusion Criteria:

• Eyes classified as either normal or atypical normal on the severity grading scheme.

• Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.

• 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, 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

Related Conditions & MeSH terms

• Corneal Degeneration
• Corneal Dystrophies, Hereditary
• Corneal Ectasia
• Keratoconus
• Pellucid Marginal Corneal Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Cornea Associates of Texas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Cornea Associates of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K-Max	Change in K-Max measured by corneal topography, compared to baseline	12 Months
Primary	K-Mean	Change in K-Mean measured by corneal topography, compared to baseline	12 Months
Secondary	Uncorrected Visual Acuity	Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline	12 Months
Secondary	Best Corrected Visual Acuity	Change in best corrected visual acuity using snellen measurements, compared to baseline	12 Months
Secondary	Central Pachymetry	Change in central pachymetry, measured by Pentacam compared to baseline	12 Months