Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

Stopped early · Phase 2

Conditions studied: Keratoconus, Cornea Ectasia

In brief

To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.

Key facts

Study ID

NCT04240457

Run by

Arbor Center for Eye Care

People needed

11

Starts

2020-07-08

Expected to finish

2023-02-18

Last updated by the study team

2024-12-12

Who can join

Age: 12 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers
• Subjects who have one or both eyes that meet criteria 1 and one or more of the following criteria will be considered candidates for this study:
• 12 years of age or older
• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
• Fleischer ring
• Vogt's striae
• Decentered corneal apex
• Munson's sign
• Rizzutti's sign
• Apical Corneal scarring consistent with Bowman's breaks
• Scissoring of the retinoscopic reflex
• Crab-claw appearance on topography
• Steepest keratometry (Kmax) value ≥ 47.20 D
• I-S keratometry difference > 1.5 D on the Pentacam map
• Posterior corneal elevation >16 microns
• Thinnest corneal point <485 microns
• Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK in keratoconus suspect eyes
• Contact Lens Wearers Only:
• a. Removal of contact lenses for the required period of time prior to the screening refraction:
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• Contact Lens Wearers Only:
• Removal of contact lenses for the required period of time prior to the screening refraction:

Where it is running

• Arbor Center for Eye Care — Orland Park, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.