Recruiting
Phase 1
Phase 2

PXL-Platinum 330

Sponsor:

Colorado Eye Consultants/Cornea Consultants of Colorado

Code:

NCT04401865

Conditions

Corneal Ectasia

Keratoconus

Pellucid Marginal Corneal Degeneration

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Study Details

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.

Conditions

Corneal Ectasia

Keratoconus

Pellucid Marginal Corneal Degeneration

Study ID

NCT04401865

Start date

Jun 1, 2020

Status verified date

Jan, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulsed, Accelerated

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

active comparator: Conventional

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

Interventions

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

Primary outcome measure

  • Corrected distance visual acuity [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Colorado Eye Consultants/Corneal Consultants of Colorado

Recruiting

Littleton, Colorado, United States, 80120

Contacts

Principal Investigator:

S. Lance Forstot, M.D.

Cleveland Eye Clinic

Recruiting

Brecksville, Ohio, United States, 44141

Contacts

Principal Investigator:

Shamik Bafna, MD

More Information

Sponsor

Colorado Eye Consultants/Cornea Consultants of Colorado

Last update posted

Jan 25, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Eye Consultants/Cornea Consultants of Colorado on 2022-01-25.