Safety and Effectiveness of the PXL-Platinum 330 System

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401865
• Other study ID #: PXL-330
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Colorado Eye Consultants/Cornea Consultants of Colorado
• Contact: Shivam Patel, BS
• Phone: 720-709-7523
• Email: spatel[@]corneaonline.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.

3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.

4. Must be at least 8 years of age.

5. Non-consenting/impaired individuals with a LAR's signature

Exclusion Criteria:

1. Corneal thickness < 300 microns measured by ultrasound or Pentacam.

2. Contraindications or sensitivities to any study medications or their components.

3. Pregnancy or breastfeeding.

4. Any history of Herpes simplex corneal disease in an eye to be treated.

5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.

6. Inability to cooperate with diagnostic tests.

7. Current enrollment in another ophthalmic clinical trial.

Related Conditions & MeSH terms

• Corneal Ectasia
• Keratoconus
• Pellucid Marginal Corneal Degeneration

Intervention

Combination Product:
• PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Chicago Cornea Consultants, Ltd.	Highland Park	Illinois
United States	Colorado Eye Consultants/Corneal Consultants of Colorado	Littleton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado Eye Consultants/Cornea Consultants of Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uncorrected visual acuity	Change in UCVA at 6 months, compared to baseline.	6 months
Secondary	Keratometry	Change in Kmax, compared to baseline.	12 months