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

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

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

Study Overview

• Status: Recruiting
• Conditions: Keratoconus, Unstable; Bacterial Keratitis; Ectasia of Cornea
• Intervention / Treatment: Combination product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BALAMURALI AMBATI, MD, PhD; Phone Number: 541-343-5000; Email: bambati@pcvi.com

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Pacific Clear Vision Institute
      • Contact: BALAMURALI AMBATI, MD; Phone Number: 706-231-3958; Email: bambati@pcvi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; 9 mW, continuous 10 minutes of illumination	Combination product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution; Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea; Other Names: Corneal crosslinking
Experimental: Pulsed, accelerated; 18 mW, 5 sec, 5 sec off, 10 minutes of illumination	Combination product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution; Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea; Other Names: Corneal crosslinking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean keratometry in diopters	Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale	12 months

Collaborators and Investigators

• Sponsor: Pacific Clear Vision Institute
• Investigators: Principal Investigator: BALAMURALI AMBATI, MD, PhD, PCVI

Publications and helpful links

General Publications

• Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
• Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
• Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01. Erratum In: J Refract Surg. 2013 Jan;29(1):72.
• Mazzotta C, Traversi C, Caragiuli S, Rechichi M. Pulsed vs continuous light accelerated corneal collagen crosslinking: in vivo qualitative investigation by confocal microscopy and corneal OCT. Eye (Lond). 2014 Oct;28(10):1179-83. doi: 10.1038/eye.2014.163. Epub 2014 Jul 25.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 9, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis; Keratoconus
• Other Study ID Numbers: 1005312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be stored in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes