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

Who is this study for? Patients with Bacterial Keratitis, Ectasia of Cornea
What treatments are being studied? PXL-330 Platinum Device for Crosslinking with Peschke Ribofflavin Solution
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 45
Healthy Volunteers: f
View:

⁃ Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.

• 12 years of age or older

• Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)

• Presence of central or inferior steepening.

• Axial topography consistent with keratoconus

• Presence of one or more findings associated with keratoconus 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/Galilei/Orbscan/Cassini map or topography map

• Posterior corneal elevation \>16 microns

• Thinnest corneal point \<485 microns

• AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).

• Signed written informed consent

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

• For 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

• Scleral Lenses

• Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\]

• Signed written informed consent

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

Locations
United States
Oregon
Pacific Clear Vision Institute
RECRUITING
Eugene
Contact Information
Primary
BALAMURALI AMBATI, MD, PhD
bambati@pcvi.com
541-343-5000
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2030-12
Participants
Target number of participants: 300
Treatments
Experimental: Pulsed, accelerated
18 mW, 5 sec, 5 sec off, 10 minutes of illumination
Active_comparator: Conventional
9 mW, continuous 10 minutes of illumination
Related Therapeutic Areas
Sponsors
Leads: Pacific Clear Vision Institute

This content was sourced from clinicaltrials.gov