Recruiting
Phase 1

PXL-Platinum 330

Sponsor:

Pacific Clear Vision Institute

Code:

NCT03918408

Conditions

Keratoconus, Unstable

Bacterial Keratitis

Ectasia of Cornea

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

Interventions

PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Study Details

Brief summary:

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

Conditions

Keratoconus, Unstable

Bacterial Keratitis

Ectasia of Cornea

Study ID

NCT03918408

Start date

Sep 1, 2019

Status verified date

Nov, 2024

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulsed, accelerated

18 mW, 5 sec, 5 sec off, 10 minutes of illumination

active comparator: Conventional

9 mW, continuous 10 minutes of illumination

Interventions

PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Primary outcome measure

  • Mean keratometry in diopters [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

BALAMURALI AMBATI, MD, PhD

541-343-5000bambati@pcvi.com

Locations

Pacific Clear Vision Institute

Recruiting

Eugene, Oregon, United States, 97401

Contacts

BALAMURALI AMBATI, MD

706-231-3958bambati@pcvi.com

More Information

Sponsor

Pacific Clear Vision Institute

Last update posted

Nov 12, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Pacific Clear Vision Institute on 2024-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.