Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT05516004

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

Led by Cohen Laser and Vision Center · Updated on 2024-06-14

300

Participants Needed

1

Research Sites

517 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy subjects with no other medical or eye conditions
  • 18 years of age or older
  • Presence of central or inferior corneal steepening
  • Eye topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
  • At least one keratoconus or pellucid marginal degeneration sign on slit lamp exam (e.g., Fleischer ring, Vogt's striae, decentered corneal apex, Munson's sign, Rizzutti's sign, apical corneal scarring, scissoring retinoscopic reflex, crab-claw appearance on topography)
  • Steepest corneal curvature (Kmax) value of 47.2 diopters or higher
  • Keratometry difference greater than 1.5 diopters on topography or tomography maps
  • Posterior corneal elevation greater than 16 microns on tomography
  • Thinnest corneal point less than 485 microns
  • Predicted post-LASIK/PRK stromal ablation depth less than 350 microns or expected keratometry above 47.2 diopters, or undergoing PRK/SMILE with keratoconus suspect eyes
  • Persistent bacterial or fungal corneal infection not responding after more than 2 weeks of treatment or with rapid corneal thinning over 25%
  • Contact lens wearers who have removed lenses for the required time before screening
  • Signed informed consent
  • Willingness and ability to comply with follow-up schedule
Not Eligible

You will not qualify if you...

  • Active infections or collagen vascular disease
  • Allergy to study product
  • Eyes classified as normal or atypical normal in severity grading
  • Corneal thickness less than 300 microns at the thinnest point
  • Previous eye conditions other than refractive error that may cause complications (e.g., herpes simplex or zoster keratitis, recurrent erosion syndrome, acanthamoeba)
  • Clinically significant corneal scarring unrelated to keratoconus that may affect treatment
  • Pregnancy or planning to become pregnant or breastfeeding during study
  • Known sensitivity to study medications
  • Cognitive or mobility issues preventing eye drop use
  • Nystagmus or other conditions preventing steady gaze during treatment
  • Any condition interfering with or delaying epithelial healing as judged by the physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cohen Laser and Vision Center

Boca Raton, Florida, United States, 33431-1806

Actively Recruiting

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Research Team

G

GREGORY R Cohen, MD

CONTACT

J

Joshua D Cohen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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