NCT04401865

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

2.1 years

First QC Date

May 20, 2020

Last Update Submit

January 24, 2022

Conditions

Corneal EctasiaKeratoconusPellucid Marginal Corneal Degeneration

Outcome Measures

Primary Outcomes (1)

  • Corrected distance visual acuity

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

    6 months

Secondary Outcomes (2)

  • Uncorrected visual acuity

    6 months

  • Keratometry

    12 months

Study Arms (2)

Pulsed, Accelerated

EXPERIMENTAL

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

Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Conventional

ACTIVE COMPARATOR

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

Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Interventions

PXL-330 Platinum device for crosslinking with Peschke riboflavin solutionCOMBINATION_PRODUCT

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

Also known as: Corneal cross-linking
ConventionalPulsed, Accelerated

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Colorado Eye Consultants/Corneal Consultants of Colorado

Littleton, Colorado, 80120, United States

RECRUITING

Chicago Cornea Consultants, Ltd.

Highland Park, Illinois, 60035, United States

ACTIVE NOT RECRUITING

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • S. Lance Forstot, M.D.

    Colorado Eye Consultants/Corneal Consultants of Colorado

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivam Patel, BS

CONTACT

720-709-7523spatel@corneaonline.com

Wendy Bigger

CONTACT

720-709-7533wbigger@corneaonline.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 26, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)