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Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Primary Purpose

Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Sponsored by
Cornea Associates of Texas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:

  1. 8 years of age or older
  2. Signed written informed consent
  3. Willingness and ability to comply with schedule for follow-up visits

  4. Contact Lens Wearers Only:

    1. Removal of contact lenses for the required period of time prior to the screening refraction:

      Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks

    2. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
  5. Presence of central or inferior steepening.
  6. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

  7. 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. Rizzutti's sign
    6. Apical Corneal scarring consistent with Bowman's breaks
    7. Scissoring of the retinoscopic reflex
    8. Crab-claw appearance on topography
  8. Steepest keratometry (Kmax) value ≥ 47.20 D
  9. I-S keratometry difference > 1.5 D on the Pentacam/Orbscan map or topography map
  10. Posterior corneal elevation >16 microns
  11. Thinnest corneal point >300 microns

Sites / Locations

  • Cornea Associates of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pulsed 6mW/cm2

Pulsed 4mW/cm2

Arm Description

6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time

4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time

Outcomes

Primary Outcome Measures

K-Max
Change in K-Max, compared to baseline
K-Mean
Change in K-Mean, compared to baseline

Secondary Outcome Measures

Uncorrected Visual Acuity
Change in uncorrected visual acuity, compared to baseline
Best Corrected Visual Acuity
Change in best corrected visual acuity, compared to baseline
Central Pachymetry
Change in central pachymetry, compared to baseline

Full Information

First Posted
November 22, 2019
Last Updated
October 17, 2022
Sponsor
Cornea Associates of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT04177082
Brief Title
Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Official Title
Evaluation of the Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions Using Peschke Riboflavin Solution
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornea Associates of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

Brief Summary
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions
Detailed 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, pachymetry, and visual function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration, Corneal Ectasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed 6mW/cm2
Arm Type
Experimental
Arm Description
6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time
Arm Title
Pulsed 4mW/cm2
Arm Type
Experimental
Arm Description
4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time
Intervention Type
Combination Product
Intervention Name(s)
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Other Intervention Name(s)
Corneal crosslinking
Intervention Description
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Primary Outcome Measure Information:
Title
K-Max
Description
Change in K-Max, compared to baseline
Time Frame
12 Months
Title
K-Mean
Description
Change in K-Mean, compared to baseline
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Uncorrected Visual Acuity
Description
Change in uncorrected visual acuity, compared to baseline
Time Frame
12 Months
Title
Best Corrected Visual Acuity
Description
Change in best corrected visual acuity, compared to baseline
Time Frame
12 Months
Title
Central Pachymetry
Description
Change in central pachymetry, compared to baseline
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study: 8 years of age or older Signed written informed consent Willingness and ability to comply with schedule for follow-up visits 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 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses. 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: 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/Orbscan map or topography map Posterior corneal elevation >16 microns Thinnest corneal point >300 microns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyrone McCall, MD
Organizational Affiliation
Cornea Associates of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornea Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be held 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.

Learn more about this trial

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

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