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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• healthy subjects with no other medical or ocular conditions

∙ Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:

• 18 years of age or older

• Presence of central or inferior steepening (on Pentacam topograph)

• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details)

• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam

• I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map

• Posterior corneal elevation \>16 microns (µm on Pentacam tomography)

• Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography)

• Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes

• Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \>25% corneal thickness

• Contact Lens Wearers Only:

‣ Removal of contact lenses for the required period of time prior to the screening refraction:

∙ Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable 2 Weeks per decade of wear

• Signed written informed consent

• Willingness and ability to comply with schedule for follow-up visits

Locations
United States
Florida
Cohen Laser and Vision Center
RECRUITING
Boca Raton
Contact Information
Primary
GREGORY R Cohen, MD
bocalasik@yahoo.com
5619818400
Backup
Joshua D Cohen, MD
joshua@cohenlaser.com
5619818400
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2034-06-01
Participants
Target number of participants: 300
Treatments
Experimental: PXL 330
Participants will receive riboflavin 0.25% solution (Peschke TE), one drop every minute for 25 minutes to the eye, followed by UVA light 9mW/cm2 continuous mode for 10 minutes
Related Therapeutic Areas
Sponsors
Leads: Cohen Laser and Vision Center

This content was sourced from clinicaltrials.gov