Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Primary Purpose
Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Degeneration
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- 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 (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
And one or more of the following:
- 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
Exclusion Criteria:
- Eyes classified as either normal or atypical normal on the severity grading scheme.
- Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.
- 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, 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
Sites / Locations
- Cornea Associates of Texas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pulsed 5mW/cm2
Pulsed 8mW/cm2
Arm Description
5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time
8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time
Outcomes
Primary Outcome Measures
K-Max
Change in K-Max measured by corneal topography, compared to baseline
K-Mean
Change in K-Mean measured by corneal topography, compared to baseline
Secondary Outcome Measures
Uncorrected Visual Acuity
Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline
Best Corrected Visual Acuity
Change in best corrected visual acuity using snellen measurements, compared to baseline
Central Pachymetry
Change in central pachymetry, measured by Pentacam compared to baseline
Full Information
NCT ID
NCT04667572
First Posted
December 2, 2020
Last Updated
July 31, 2023
Sponsor
Cornea Associates of Texas
1. Study Identification
Unique Protocol Identification Number
NCT04667572
Brief Title
Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Official Title
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
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
No
Product Manufactured in and Exported from the U.S.
No
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
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulsed 5mW/cm2
Arm Type
Experimental
Arm Description
5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time
Arm Title
Pulsed 8mW/cm2
Arm Type
Experimental
Arm Description
8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds 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 measured by corneal topography, compared to baseline
Time Frame
12 Months
Title
K-Mean
Description
Change in K-Mean measured by corneal topography, compared to baseline
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Uncorrected Visual Acuity
Description
Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline
Time Frame
12 Months
Title
Best Corrected Visual Acuity
Description
Change in best corrected visual acuity using snellen measurements, compared to baseline
Time Frame
12 Months
Title
Central Pachymetry
Description
Change in central pachymetry, measured by Pentacam compared to baseline
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
And one or more of the following:
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
Exclusion Criteria:
Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.
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, 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing
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
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Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
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