Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

Pacific Clear Vision Institute

Status and phase

Enrolling

Phase 1

Conditions

Ectasia of Cornea

Keratoconus, Unstable

Bacterial Keratitis

Treatments

Combination Product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Study type

Interventional

Funder types

Other

Identifiers

NCT03918408

1005312

Details and patient eligibility

About

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

Full description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and visual function questionnaire.

Enrollment

300 estimated patients

Sex

All

Ages

12 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria (any of the following are reasons for exclusion):

Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <330 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:
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
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 active medical implants (e.g. cardiac pacemakers)'
Patients who are aphakic/ pseudophakic