Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Phase 1

Active, not recruiting

• Conditions: Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia

• Registration Number: NCT04667572
• Lead Sponsor: Cornea Associates of Texas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Inclusion Criteria:<br><br> - 8 years of age or older<br><br> - Signed written informed consent<br><br> - Willingness and ability to comply with schedule for follow-up visits<br><br> - Contact Lens Wearers Only:<br><br> - Removal of contact lenses (if applicable) for the required period of time prior to<br> the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue<br> 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks<br> (subjects who cannot function without wearing their contact lenses, may forgo<br> discontinuation of contact lenses)<br><br>And one or more of the following:<br><br> - Presence of central or inferior steepening.<br><br> - Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid<br> marginal degeneration<br><br> - Presence of one or more findings associated with keratoconus or pellucid marginal<br> degeneration, such as: Fleischer ring, Vogt's striae, Decentered corneal apex,<br> Munson's sign, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's<br> breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography<br><br> - Steepest keratometry (Kmax) value = 47.20 D<br><br> - I-S keratometry difference > 1.5 D on the Pentacam/Orbscan map or topography map<br><br> - Posterior corneal elevation >16 microns<br><br> - Thinnest corneal point >300 microns<br><br>Exclusion Criteria:<br><br> - Eyes classified as either normal or atypical normal on the severity grading scheme.<br><br> - Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.<br><br> - Previous ocular condition (other than refractive error) in the eye(s) to be treated<br> that may predispose the eye for future complications, for example: History of or<br> active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent<br> erosion syndrome, etc.) Clinically significant corneal scarring in the CXL treatment<br> zone that is not related to keratoconus or, in the investigator's opinion, will<br> interfere with the cross-linking procedure.<br><br> - Pregnancy (including plan to become pregnant) or lactation during the course of the<br> study<br><br> - A known sensitivity to study medications<br><br> - Patients with nystagmus or any other condition that would prevent a steady gaze<br> during the CXL treatment or other diagnostic tests.<br><br> - Patients with a current condition that, in the physician's opinion, would interfere<br> with or prolong epithelial healing

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
K-Max;K-Mean

Secondary Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity;Best Corrected Visual Acuity;Central Pachymetry