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

NCT03918408 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 1005312
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keratoconus, Unstable; Bacterial Keratitis; Ectasia of Cornea

Outcome Measures

Primary Outcomes (1)

• Mean keratometry in diopters

  Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer

  12 months

Secondary Outcomes (1)

• Best corrected visual acuity

  12 months

Study Arms (2)

Pulsed, accelerated

EXPERIMENTAL

18 mW, 5 sec, 5 sec off, 10 minutes of illumination

Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Conventional

ACTIVE COMPARATOR

9 mW, continuous 10 minutes of illumination

Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Interventions

PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution COMBINATION_PRODUCT

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Also known as: Corneal crosslinking

Conventional; Pulsed, accelerated

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Clear Vision Institute: lead

Study Sites (1)

Pacific Clear Vision Institute

Eugene, Oregon, 97401, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 16765803 BACKGROUND

• 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.

  PMID: 20138607 BACKGROUND

• 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.

  PMID: 23347367 BACKGROUND

• 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.

  PMID: 25060847 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• BALAMURALI AMBATI, MD, PhD

  PCVI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BALAMURALI AMBATI, MD, PhD

CONTACT

541-343-5000; bambati@pcvi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomized at outset
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment of patients with disease

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 17, 2019
• Study Start: September 1, 2019
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)