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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

No Placebo-Only Group

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

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I have streaks in the eye's clear layer.

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I am healthy with no medical or eye conditions.

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I am 18 years old or older.

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My eye condition is diagnosed as keratoconus, post-surgical ectasia, or pellucid marginal degeneration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met