PXL-Platinum 330 in Eyes With Corneal Thinning Conditions

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05489510
• Other study ID #: STUDY21040139
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: August 15, 2023
• Est. completion date: December 31, 2031

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in conjunction with the UVA light as a photosensitizer.

Description:

The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen cross-linking (performed using the PXL-Platinum 330 system) for treating corneal curvature and biomechanical anomalies associated with corneal thinning conditions, e.g., progressive or non-progressive keratoconus, pellucid marginal degeneration, and treatment of patients with bacterial or fungal keratitis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older.

• 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: a. Fleischer ring b. Vogt's striae c. Decentered corneal apex d. Munson's sign e. Rizzutti's sign f. Apical Corneal scarring consistent with Bowman's breaks g. Scissoring of the retinoscopic reflex h. Crab-claw appearance on topography

• Steepest keratometry (Kmax) value = 47.20 D.

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

• Posterior corneal elevation >16 microns.

• Thinnest corneal point <485 microns.

• Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eye.s 10. Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid. progression of corneal thinning, with loss of >25% corneal thickness

• 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 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear

• Signed written informed consent.

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

Exclusion Criteria:

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

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

• 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.

• 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

• Keratoconus

Intervention

Combination Product:
• Pulsed or continuous lighting
The cross-linking procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source and riboflavin solution).

Locations

Country	Name	City	State
United States	UPMC Eye Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Vishal Jhanji

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy measurements by best spectacle-corrected visual acuity	Percentage of eyes that had a BSCVA worse than 20/40	12 months
Primary	PXL-Platinum 330 system	Keratometry	12 months