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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094090
• Other study ID #: PXL-2211
• Status: Recruiting
• Phase: Phase 2
• Start date: October 19, 2019
• Est. completion date: December 19, 2024

Study information

• Verified date: August 2022
• Source: Goodman Eye Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 19, 2024
• Est. primary completion date: October 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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:

1. Fleischer ring

2. Vogt's striae

3. Decentered corneal apex

4. Munson's sign

5. Apical Corneal scarring consistent with Bowman's breaks

6. Scissoring of the retinoscopic reflex

7. 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:

a. 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:

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

2. Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in the eye(s) to be treated.

3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)

2. 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.

4. Pregnancy (including plan to become pregnant) or lactation during the course of the study

5. A known sensitivity to study medications

6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.

7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.

Related Conditions & MeSH terms

• Corneal Diseases
• 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	Goodman Eye Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Goodman Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-contact corrected visual acuity (BSCVA)	Change in BSCVA compared to baseline.	3, 6, and 12 months
Secondary	Uncorrected visual acuity	Change in UCVA compared to baseline.	3, 6, and 12 months
Secondary	Keratometry	Change in Kmax, compared to baseline.	1 year