NCT05516004

Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cohen Laser and Vision Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.

Detailed description

This study is an investigator initiated single center study that will be conducted over 10 years. Up to 300 patients with cornea thinning conditions will be enrolled. This is a prospective, single-arm, nonrandomized single site study to determine the safety and effectiveness of the PXL Platinum 330 system for performing collagen cross linking (CXL) in eyes with cornea thinning. Subjects with a history of keratoconus, pellucid marginal degeneration, thin corneas undergoing LASIK, PRK or INTACS will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine eligibility. Informed consent will be obtained from each subject before performing any study procedures. Eyes undergoing CXL will have topical anesthetic administered and then have topical riboflavin instilled on the cornea for 25 minutes, followed by UVA light 9mW/cm2 for 10 minutes. The CXL procedures will be performed on an outpatient basis using the PXL Platinum 330 System (UVA light source with riboflavin solution). All use of the PXL Platinum 330 System will be in accordance with this protocol and the general instructions provided be the manufacturer in the PXL Platinum 330 operator's manual. All subjects will be evaluated at screening/baseline, Day 0 (treatment day), 1 day, 1 week and 1,3,6 and 12 months after treatment. Topographic keratometry, posterior cornea measurements (with Pentacam), cornea topography, manifest refraction, and measurements of best spectacle corrected visual acuity and intraocular pressure will be obtained at baseline and appropriate times after the CXL treatment. Safety monitoring throughout the study will include observations for subjective complaints, complications, adverse events, clinically significant findings on ophthalmic examination, dilated fundus examination and slit-lamp examination. Quality of vision and subjective complaints will be evaluated preoperatively and postoperatively with a vision related quality of life questionnaire.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DEVICE	PXL Platinum 330 system	to determine the efficacy of riboflavin solution and UV light to treat cornea thinning conditions

Timeline

• Start date: 2024-07-01
• Primary completion: 2034-06-01
• Completion: 2034-06-01
• First posted: 2022-08-25
• Last updated: 2024-06-14

Locations

1 site across 1 country: United States