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

• Sponsor: Cornea Associates of Texas (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04667572
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.9
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia	Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	Phase 1

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, pachymetry, and visual function.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulsed 5mW/cm2 5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time	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: Corneal Crosslinking
Experimental: Pulsed 8mW/cm2 8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time	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: Corneal Crosslinking

Outcome Measures

Primary Outcome Measures

1. K-Max [12 Months]

   Change in K-Max measured by corneal topography, compared to baseline

2. K-Mean [12 Months]

   Change in K-Mean measured by corneal topography, compared to baseline

Secondary Outcome Measures

1. Uncorrected Visual Acuity [12 Months]

   Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline

2. Best Corrected Visual Acuity [12 Months]

   Change in best corrected visual acuity using snellen measurements, compared to baseline

3. Central Pachymetry [12 Months]

   Change in central pachymetry, measured by Pentacam compared to baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornea Associates of Texas	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Cornea Associates of Texas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cornea Associates of Texas
• ClinicalTrials.gov Identifier: NCT04667572
• Other Study ID Numbers: PXL-330-CAT-2
• First Posted: Dec 14, 2020
• Last Update Posted: Mar 8, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Keratoconus; Corneal Dystrophies, Hereditary; Riboflavin

Study Results

No Results Posted as of Mar 8, 2022