RECRUITING

Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning

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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

This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.

Official Title

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

Quick Facts

Study Start:2024-07-01

Study Completion:2034-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05516004

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* healthy subjects with no other medical or ocular conditions * 18 years of age or older * Presence of central or inferior steepening (on Pentacam topograph) * Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details) * Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam * I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map * Posterior corneal elevation \>16 microns (µm on Pentacam tomography) * Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography) * Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes * 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: * Removal of contact lenses for the required period of time prior to the screening refraction: * Signed written informed consent * Willingness and ability to comply with schedule for follow-up visits	* active infections, collagen vascular disease, allergic to product * 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: * 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 cognitive or ambulatory conditions that would prevent eye drop compliance with 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.

Inclusion Criteria

Exclusion Criteria

* healthy subjects with no other medical or ocular conditions
* 18 years of age or older
* Presence of central or inferior steepening (on Pentacam topograph)
* Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details)
* Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam 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 on simK or Pentacam
* I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
* Posterior corneal elevation \>16 microns (µm on Pentacam tomography)
* Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography)
* Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
* 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:
* Removal of contact lenses for the required period of time prior to the screening refraction:
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits

* active infections, collagen vascular disease, allergic to product
* 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:
* 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 cognitive or ambulatory conditions that would prevent eye drop compliance with 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.

Contacts and Locations

Study Contact

GREGORY R Cohen, MD

CONTACT

5619818400

bocalasik@yahoo.com

Joshua D Cohen, MD

CONTACT

5619818400

joshua@cohenlaser.com

Principal Investigator

Kelly Fitzgerald

STUDY_CHAIR

WCG IRB

Study Locations (Sites)

Cohen Laser and Vision Center

Boca Raton, Florida, 33431-1806

United States

Collaborators and Investigators

Sponsor: Cohen Laser and Vision Center

Kelly Fitzgerald, STUDY_CHAIR, WCG IRB

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 Date2024-07-01

Study Completion Date2034-06-01

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2034-06-01

Terms related to this study

Additional Relevant MeSH Terms

Keratoconus