Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

Phase 1

Recruiting

• Conditions: Ectasia of Cornea; Bacterial Keratitis; Keratoconus, Unstable
• Interventions: Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

• Registration Number: NCT03918408
• Lead Sponsor: Pacific Clear Vision Institute

Brief Summary

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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, and visual function questionnaire.

Study Timeline

• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-17
• Study Start: 2019-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-09
• Last Update Posted: 2024-11-12
• Primary Completion: 2029-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Subjects who have one or both eyes that meet criteria 1 & 2 and 1 or more of the following criteria will be considered candidates for this study.

• 12 years of age or older
• Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus
• Presence of one or more findings associated with keratoconus 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/Galilei/Orbscan/Cassini map or topography map
• Posterior corneal elevation >16 microns
• Thinnest corneal point <485 microns
• AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• For Contact Lens Wearers Only: 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
• Scleral Lenses
• Investigator Discretion [Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening]
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria (any of the following are reasons for exclusion):

• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal pachymetry at the screening exam that is <330 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:
• History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, 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 active medical implants (e.g. cardiac pacemakers)'
• Patients who are aphakic/ pseudophakic

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed, accelerated	PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution	18 mW, 5 sec, 5 sec off, 10 minutes of illumination
Conventional	PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution	9 mW, continuous 10 minutes of illumination

Primary Outcome Measures

Name	Time	Method
Mean keratometry in diopters	12 months	Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	12 months	Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale

Trial Locations

Locations (1)

Pacific Clear Vision Institute; 🇺🇸 Eugene, Oregon, United States