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Procedure

Corneal Collagen Cross-Linking Techniques for Keratoconus

Phase 3

Waitlist Available

Research Sponsored by Center for Sight, Sacramento, CA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having a diagnosis of keratoconus or other corneal ectatic disorder

Axial topography consistent with keratoconus or other corneal ectatic disorder

Must not have

A history of previous corneal transplant in the study eye

Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the safety and effectiveness of two different techniques for corneal cross-linking (CXL) in eyes with keratoconus and other corneal ectatic disorders. Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.

Who is the study for?

This trial is for individuals at least 12 years old with keratoconus or other corneal ectatic disorders. Participants must provide consent, have specific topography map changes, and be willing to use birth control if applicable. Those with prior CXL treatment, corneal transplants, certain ocular conditions, allergies to study materials, or inadequate corneal thickness are excluded.

What is being tested?

The study compares two techniques of Corneal Collagen Cross-Linking (CXL) treatments for strengthening the cornea: Epi-OFF (removal of the outer layer of the cornea) and Epi-ON (outer layer left intact), both using Ricrolin+ and VEGA UV-A system in a randomized design.

What are the potential side effects?

Potential side effects may include discomfort or pain in the eye, temporary visual disturbances like blurriness or halos around lights, sensitivity to light, inflammation or swelling of the eye tissues, and delayed healing of the outer layer of the cornea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with keratoconus or a similar eye condition.

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My eye condition is related to a thinning cornea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a corneal transplant in one of my eyes.

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I do not have any conditions that prevent me from keeping my gaze steady.

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My eyes have no past conditions that could risk surgery or block vision improvement.

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I have had CXL treatment in the eye being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in corneal curvature

Secondary study objectives

Change in best-corrected visual acuity (BSCVA)

Change in manifest refraction spherical equivalent

Change in thinnest pachymetry

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: Epi-ON CXLActive Control2 Interventions

The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.

Group II: Epi-OFF CXLActive Control2 Interventions

The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.

0 / 6Eligibility criteria met