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

Primary Purpose

Keratoconus, Unstable, Ectasia Corneal, Bacterial Keratitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PXL 330 Platinum device/Riboflavin
Sponsored by
Eye Specialists of Indiana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus, Unstable

Eligibility Criteria

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

Inclusion Criteria:Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12. Criteria 13 is only relevant for contact lens wearers.

  1. 12 years of age or older
  2. Signed written informed consent
  3. Willingness and ability to comply with schedule for follow-up visits
  4. Presence of central or inferior steepening
  5. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
  6. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as

    1. Fleisher 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
  7. Steepest keratometry (Kmax) value greater than or equal to 47.2
  8. I-S keratometry difference < 1.5 D on the Pentacam map or topography map
  9. Posterior corneal elevation > 16 microns
  10. Thinnest corneal point <485 microns
  11. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2, or patients undergoing PRK/SMILE in keratoconus suspect eyes
  12. Bacterial or fungal 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
  13. Contact lens wearers only:

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

Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear -

Exclusion Criteria:

  1. Eyes classified as normal or atypical normal on the severity grading scheme
  2. Corneal pachymetry at the screening exam that is <300 microns at the the thinnest point in the eye(s) to be treated.
  3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

    1. History of or active corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthamoeba, etc.)
    2. Clinically significant corneal scarring the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
  4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
  5. A known sensitivity to the study medications
  6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.
  7. Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.

    -

Sites / Locations

  • Eye Specialists of IndianaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed Accelerated

Conventional

Arm Description

30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Best corrected visual acuity
Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale

Full Information

First Posted
December 27, 2019
Last Updated
February 13, 2023
Sponsor
Eye Specialists of Indiana
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1. Study Identification

Unique Protocol Identification Number
NCT04213885
Brief Title
Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes With Corneal Thinning Position
Official Title
Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking With Corneal Thinning Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
September 1, 2029 (Anticipated)
Study Completion Date
September 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye Specialists of Indiana

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Unstable, Ectasia Corneal, Bacterial Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Treatment of patients with disease
Masking
Outcomes Assessor
Masking Description
Randomized at outset
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Accelerated
Arm Type
Experimental
Arm Description
30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea
Intervention Type
Combination Product
Intervention Name(s)
PXL 330 Platinum device/Riboflavin
Intervention Description
30mW, 5 sec, 5 sec off, 10 minutes of illumination
Primary Outcome Measure Information:
Title
Mean keratometry in diopters
Description
Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12. Criteria 13 is only relevant for contact lens wearers. 12 years of age or older Signed written informed consent Willingness and ability to comply with schedule for follow-up visits 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 Fleisher 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 greater than or equal to 47.2 I-S keratometry difference < 1.5 D on the Pentacam 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, or patients undergoing PRK/SMILE in keratoconus suspect eyes Bacterial or fungal 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: Removal of contact lenses for the require period of time prior to the screening refraction: Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear - Exclusion Criteria: Eyes classified as normal or atypical normal on the severity grading scheme Corneal pachymetry at the screening exam that is <300 microns at the 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, acanthamoeba, etc.) Clinically significant corneal scarring 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 the study medications Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests. Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clark L Springs, MD
Phone
317-925-2200
Email
csprings@iupui.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Glenn Kirk, OD
Phone
317-925-2200
Email
gkirk@esicare.com
Facility Information:
Facility Name
Eye Specialists of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clark L Springs, MD
Phone
317-925-2200
Email
csprings@iupui.edu
First Name & Middle Initial & Last Name & Degree
Glenn Kirk, OD
Phone
317-925-2200
Email
gkirk@esicare.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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