RECRUITING

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

Conditions

Keratoconus, Unstable Bacterial Keratitis Ectasia of Cornea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2019-09-01

Study Completion:2030-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03918408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* 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
* 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

BALAMURALI AMBATI, MD, PhD

CONTACT

541-343-5000

bambati@pcvi.com

Principal Investigator

BALAMURALI AMBATI, MD, PhD

PRINCIPAL_INVESTIGATOR

PCVI

Study Locations (Sites)

Pacific Clear Vision Institute

Eugene, Oregon, 97401

United States

Collaborators and Investigators

Sponsor: Pacific Clear Vision Institute

BALAMURALI AMBATI, MD, PhD, PRINCIPAL_INVESTIGATOR, PCVI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-01

Study Completion Date2030-12

Study Record Updates

Study Start Date2019-09-01

Study Completion Date2030-12

Terms related to this study

Additional Relevant MeSH Terms

Keratoconus, Unstable
Bacterial Keratitis
Ectasia of Cornea