Back to resultsPXL-Platinum 330 in Eyes With Corneal Thinning Conditions
Primary Purpose
Corneal Thinning, Keratoconus
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pulsed or continuous lighting
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Thinning
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older.
- 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: a. Fleischer ring b. Vogt's striae c. Decentered corneal apex d. Munson's sign e. Rizzutti's sign f. Apical Corneal scarring consistent with Bowman's breaks g. Scissoring of the retinoscopic reflex h. 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.
- Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eye.s 10. Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid. progression of corneal thinning, with loss of >25% corneal thickness
- Contact Lens Wearers Only: a. 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
- Signed written informed consent.
- Willingness and ability to comply with schedule for follow-up.
Exclusion Criteria:
- Eyes classified as either normal or atypical normal on the severity grading scheme.
- Corneal pachymetry at the screening exam that is <300 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
Sites / Locations
- UPMC Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pulsed lighting
Continuous lighting
Arm Description
Outcomes
Primary Outcome Measures
PXL-Platinum 330 system
Keratometry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05489510
Brief Title
PXL-Platinum 330 in Eyes With Corneal Thinning Conditions
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
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
December 31, 2031 (Anticipated)
Study Completion Date
December 31, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vishal Jhanji
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
This study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in conjunction with the UVA light as a photosensitizer.
Detailed Description
The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen cross-linking (performed using the PXL-Platinum 330 system) for treating corneal curvature and biomechanical anomalies associated with corneal thinning conditions, e.g., progressive or non-progressive keratoconus, pellucid marginal degeneration, and treatment of patients with bacterial or fungal keratitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Thinning, Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, double-arm, randomized single-site study
Masking
Investigator
Masking Description
Subjects will be assigned randomly to either pulsed or continuous lighting.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed lighting
Arm Type
Other
Arm Title
Continuous lighting
Arm Type
Other
Intervention Type
Combination Product
Intervention Name(s)
Pulsed or continuous lighting
Intervention Description
The cross-linking procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source and riboflavin solution).
Primary Outcome Measure Information:
Title
PXL-Platinum 330 system
Description
Keratometry
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Efficacy measurements by best spectacle-corrected visual acuity
Description
Percentage of eyes that had a BSCVA worse than 20/40
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older.
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: a. Fleischer ring b. Vogt's striae c. Decentered corneal apex d. Munson's sign e. Rizzutti's sign f. Apical Corneal scarring consistent with Bowman's breaks g. Scissoring of the retinoscopic reflex h. 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.
Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eye.s 10. Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid. progression of corneal thinning, with loss of >25% corneal thickness
Contact Lens Wearers Only: a. 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
Signed written informed consent.
Willingness and ability to comply with schedule for follow-up.
Exclusion Criteria:
Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <300 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishal Jhanji, MD
Organizational Affiliation
UPMC Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
In addition to UPMC having access to identifiable information, Peschke Meditrade of Switzerland will have access to de-identifiable information.
IPD Sharing Time Frame
An indefinite period.
IPD Sharing Access Criteria
Deidentified individual participant data sets with other researchers outside of your study team.
Learn more about this trial
PXL-Platinum 330 in Eyes With Corneal Thinning Conditions
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