PXL-Platinum 330 in Eyes With Corneal Thinning Conditions

Brief Title

PXL-Platinum 330 in Eyes With Corneal Thinning Conditions

Official Title

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

Brief Summary

      This study is being conducted to evaluate the safety and effectiveness of using the PXL
      Platinum 330 system for performing corneal collagen cross-linking (CXL) for the treatment of
      corneal thinning disorders. The PXL Platinum 330 system is a combination product consisting
      of a UVA 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin
      (Peschke-TE 0.25% ophthalmic solution or Peschke-L 0.23% ophthalmic solution) administered in
      conjunction with the UVA light as a photosensitizer.
    

Detailed Description

      The primary objective of this study is to evaluate the safety and effectiveness of corneal
      collagen cross-linking (performed using the PXL-Platinum 330 system) for treating corneal
      curvature and biomechanical anomalies associated with corneal thinning conditions, e.g.,
      progressive or non-progressive keratoconus, pellucid marginal degeneration, and treatment of
      patients with bacterial or fungal keratitis.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

PXL-Platinum 330 system

Condition

Corneal Thinning

Intervention

Pulsed or continuous lighting

Study Arms / Comparison Groups

 Pulsed lighting

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Combination Product

Estimated Enrollment

300

Start Date

September 15, 2022

Completion Date

December 31, 2031

Primary Completion Date

December 31, 2031

Eligibility Criteria

        Inclusion Criteria:

          -  18 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: a. Fleischer ring b. Vogt's striae c. Decentered corneal apex
             d. Munson's sign e. Rizzutti's sign f. Apical Corneal scarring consistent with
             Bowman's breaks g. Scissoring of the retinoscopic reflex h. 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.

          -  Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry
             >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eye.s 10. 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: a. 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.

        Exclusion Criteria:

          -  Eyes classified as either normal or atypical normal on the severity grading scheme.

          -  Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in
             the eye(s) to be treated.

          -  Previous ocular condition (other than refractive error) in the eye(s) to be treated
             that may predispose the eye for future complications, for example:

               1. History of or active corneal disease (e.g., herpes simplex, herpes zoster
                  keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)

               2. Clinically significant corneal scarring in the CXL treatment zone that is not
                  related to keratoconus or, in the investigator's opinion, will interfere with the
                  cross-linking procedure.

          -  Pregnancy (including plan to become pregnant) or lactation during the course of the
             study.

          -  A known sensitivity to study medications.

          -  Patients with nystagmus or any other condition that would prevent a steady gaze during
             the CXL treatment or other diagnostic tests.

          -  Patients with a current condition that, in the physician's opinion, would interfere
             with or prolong epithelial healing.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Vishal Jhanji, MD, 4126473373, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT05489510

Organization ID

STUDY21040139

Responsible Party

Sponsor-Investigator

Study Sponsor

Vishal Jhanji

Study Sponsor

Vishal Jhanji, MD, Principal Investigator, UPMC Eye Center

Verification Date

August 2022