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

NCT ID: NCT04177082

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2022-05-05

Brief Summary

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

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.

Conditions

Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed 6mW/cm2

6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time

Group Type: EXPERIMENTAL

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Intervention Type: COMBINATION_PRODUCT

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Pulsed 4mW/cm2

4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time

Group Type: EXPERIMENTAL

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Intervention Type: COMBINATION_PRODUCT

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Corneal crosslinking

Eligibility Criteria

Inclusion Criteria

Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:

1. 8 years of age or older

2. Signed written informed consent

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

4. Contact Lens Wearers Only:

1. Removal of contact lenses for the required period of time prior to the screening refraction:

Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks

2. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.

5. Presence of central or inferior steepening.

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

7. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:

1. Fleischer ring

2. Vogt's striae

3. Decentered corneal apex

4. Munson's sign

5. Rizzutti's sign

6. Apical Corneal scarring consistent with Bowman's breaks

7. Scissoring of the retinoscopic reflex

8. Crab-claw appearance on topography

8. Steepest keratometry (Kmax) value ≥ 47.20 D

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

10. Posterior corneal elevation >16 microns

11. Thinnest corneal point >300 microns

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cornea Associates of Texas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tyrone McCall, MD

Role: PRINCIPAL_INVESTIGATOR

Cornea Associates of Texas

Locations

Cornea Associates of Texas

Dallas, Texas, United States

Countries

United States

Other Identifiers

PXL-330-CAT

Identifier Type: -

Identifier Source: org_study_id