UnknownPhase 1/2

Safety and Effectiveness of the PXL-Platinum 330 System

United States300 participantsStarted 2020-06-01

Plain-language 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.

Who can participate

Age range8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Corrected distance visual acuity

Timeframe: 6 months

Trial details

NCT IDNCT04401865

SponsorColorado Eye Consultants/Cornea Consultants of Colorado

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-30

Contact for this trial

Shivam Patel, BS

720-709-7523 spatel@corneaonline.com

View on ClinicalTrials.gov More Corneal Ectasia trials