← Back to Search

Cornea Crosslinking

Cornea Crosslinking for Keratoconus (CXL Trial)

Phase 2
Recruiting
Research Sponsored by Cohen Laser and Vision Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Vogt's striae
healthy subjects with no other medical or ocular conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Summary

"This trial aims to see if cornea cross linking is effective in treating patients with Keratoconus or other conditions that cause thinning of the cornea."

Who is the study for?
This trial is for adults over 18 with Keratoconus or similar conditions causing cornea thinning. Participants must show signs like Fleischer ring, Vogt's striae, and have a specific shape to their cornea. Those with other medical or eye issues are not eligible.
What is being tested?
The study tests the PXL-Platinum 330 system's ability to strengthen the cornea in patients with Keratoconus by using a technique called crosslinking.
What are the potential side effects?
Potential side effects may include discomfort in the eye, temporary vision changes, and sensitivity to light due to the crosslinking procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have streaks in the eye's clear layer.
Select...
I am healthy with no medical or eye conditions.
Select...
I am 18 years old or older.
Select...
My eye condition is diagnosed as keratoconus, post-surgical ectasia, or pellucid marginal degeneration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Belin-Ambrosio ectasia score
Stability in maximum and mean keratometric diopters (Kmax)
Secondary study objectives
Change in best corrected visual acuity
Cornea
Astigmatism

Trial Design

1Treatment groups
Experimental Treatment
Group I: PXL 330Experimental Treatment1 Intervention
Participants will receive riboflavin 0.25% solution (Peschke TE), one drop every minute for 25 minutes to the eye, followed by UVA light 9mW/cm2 continuous mode for 10 minutes

Find a Location

Who is running the clinical trial?

Cohen Laser and Vision CenterLead Sponsor
Kelly FitzgeraldStudy ChairWCG IRB
~200 spots leftby Jun 2034