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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04177082
• Other study ID #: PXL-330-CAT
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2020
• Est. completion date: May 5, 2022

Study information

• Verified date: September 2022
• 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: Completed
• Enrollment: 200
• Est. completion date: May 5, 2022
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

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, compared to baseline	12 Months
Primary	K-Mean	Change in K-Mean, compared to baseline	12 Months
Secondary	Uncorrected Visual Acuity	Change in uncorrected visual acuity, compared to baseline	12 Months
Secondary	Best Corrected Visual Acuity	Change in best corrected visual acuity, compared to baseline	12 Months
Secondary	Central Pachymetry	Change in central pachymetry, compared to baseline	12 Months