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Safety and Effectiveness of the PXL-Platinum 330 System

Primary Purpose

Corneal Ectasia, Keratoconus, Pellucid Marginal Corneal Degeneration

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

About this trial

This is an interventional treatment trial for Corneal Ectasia

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
Must be at least 8 years of age.
Non-consenting/impaired individuals with a LAR's signature

Exclusion Criteria:

Corneal thickness < 300 microns measured by ultrasound or Pentacam.
Contraindications or sensitivities to any study medications or their components.
Pregnancy or breastfeeding.
Any history of Herpes simplex corneal disease in an eye to be treated.
Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
Inability to cooperate with diagnostic tests.
Current enrollment in another ophthalmic clinical trial.

Sites / Locations

Colorado Eye Consultants/Corneal Consultants of ColoradoRecruiting
Chicago Cornea Consultants, Ltd.
Cleveland Eye ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulsed, Accelerated

Conventional

Arm Description

5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Outcomes

Primary Outcome Measures

Corrected distance visual acuity

Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.

Secondary Outcome Measures

Uncorrected visual acuity

Change in UCVA at 6 months, compared to baseline.

Keratometry

Change in Kmax, compared to baseline.

Full Information

NCT ID

NCT04401865

First Posted

May 20, 2020

Last Updated

January 24, 2022

Sponsor

Colorado Eye Consultants/Cornea Consultants of Colorado

1. Study Identification

Unique Protocol Identification Number

NCT04401865

Brief Title

Safety and Effectiveness of the PXL-Platinum 330 System

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

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Colorado Eye Consultants/Cornea Consultants of Colorado

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

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, intraocular pressure, and pachymetry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Ectasia, Keratoconus, Pellucid Marginal Corneal Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulsed, Accelerated

Arm Type

Experimental

Arm Description

5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Arm Title

Conventional

Arm Type

Active Comparator

Arm Description

4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Intervention Type

Combination Product

Intervention Name(s)

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Other Intervention Name(s)

Corneal cross-linking

Intervention Description

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

Primary Outcome Measure Information:

Title

Corrected distance visual acuity

Description

Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Uncorrected visual acuity

Description

Change in UCVA at 6 months, compared to baseline.

Time Frame

6 months

Title

Keratometry

Description

Change in Kmax, compared to baseline.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study. Must be at least 8 years of age. Non-consenting/impaired individuals with a LAR's signature Exclusion Criteria: Corneal thickness < 300 microns measured by ultrasound or Pentacam. Contraindications or sensitivities to any study medications or their components. Pregnancy or breastfeeding. Any history of Herpes simplex corneal disease in an eye to be treated. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. Inability to cooperate with diagnostic tests. Current enrollment in another ophthalmic clinical trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shivam Patel, BS

Phone

720-709-7523

spatel@corneaonline.com

First Name & Middle Initial & Last Name or Official Title & Degree

Wendy Bigger

Phone

720-709-7533

wbigger@corneaonline.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

S. Lance Forstot, M.D.

Organizational Affiliation

Colorado Eye Consultants/Corneal Consultants of Colorado

Official's Role

Principal Investigator

Facility Information:

Facility Name

Colorado Eye Consultants/Corneal Consultants of Colorado

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shivam Patel, BS

Phone

720-709-7523

spatel@corneaonline.com

First Name & Middle Initial & Last Name & Degree

Wendy Bigger

Phone

720-709-7533

wbigger@corneaonline.com

First Name & Middle Initial & Last Name & Degree

S. Lance Forstot, M.D.

First Name & Middle Initial & Last Name & Degree

Robert I Fish, M.D.

First Name & Middle Initial & Last Name & Degree

Karen M Repine, M.D.

Facility Name

Chicago Cornea Consultants, Ltd.

City

Highland Park

State/Province

Illinois

ZIP/Postal Code

60035

Country

United States

Individual Site Status

Active, not recruiting

Facility Name

Cleveland Eye Clinic

City

Brecksville

State/Province

Ohio

ZIP/Postal Code

44141

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erin Kus-Kreidler

Phone

216-503-6535

ekus-kreidler@clevelandeyeclinic.com

First Name & Middle Initial & Last Name & Degree

Shamik Bafna, MD

First Name & Middle Initial & Last Name & Degree

William Wiley, MD

First Name & Middle Initial & Last Name & Degree

Kathleen Jee, MD

First Name & Middle Initial & Last Name & Degree

Jeffrey Augustine, OD

First Name & Middle Initial & Last Name & Degree

Kayla Karpuk, OD

12. IPD Sharing Statement

Plan to Share IPD

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Safety and Effectiveness of the PXL-Platinum 330 System

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