What is the mechanism of action of this treatment?

Corneal Cross-Linking (CXL) is a treatment for Keratoconus that involves applying riboflavin (vitamin B2) to the cornea and then exposing it to ultraviolet A (UVA) light. This process strengthens the collagen fibers in the cornea, making it more rigid and stable. This is particularly important for Keratoconus patients because the disease causes the cornea to thin and bulge, leading to distorted vision. By reinforcing the corneal structure, CXL can halt the progression of Keratoconus and improve visual outcomes.

What side effects are associated with this type of intervention?

Corneal Cross-Linking (CXL) is a common treatment for Keratoconus that involves the use of ultraviolet light and riboflavin to strengthen corneal collagen fibers. Known side effects of CXL can include transient discomfort, corneal haze, and, in some cases, a temporary reduction in visual acuity. There is also a risk of infection and delayed epithelial healing, particularly in the epithelium-off (epi-off) technique. Long-term complications are rare but can include persistent corneal haze and scarring.

What prior FDA approvals exist?

The FDA has approved Corneal Cross-Linking (CXL) for the treatment of progressive Keratoconus. This procedure involves the use of ultraviolet (UV) light and riboflavin (vitamin B2) to strengthen the collagen fibers in the cornea, thereby stabilizing the corneal structure and halting the progression of the disease. The specific products approved for this treatment include the KXL System by Avedro, which utilizes UV light, and the associated riboflavin solutions, such as Photrexa Viscous and Photrexa. These approvals mark significant advancements in the management of Keratoconus, providing a minimally invasive option to improve corneal stability.

What other types of research exist?

Promising novel alternatives to Corneal Cross-Linking for Keratoconus patients include: 1) Customized Corneal Cross-Linking (CXL) which tailors the treatment to the specific corneal topography of the patient, potentially improving outcomes. 2) Intrastromal Corneal Ring Segments (ICRS) which are implants that help flatten the cornea and improve vision. 3) Topography-Guided Photorefractive Keratectomy (TG-PRK) combined with CXL, which reshapes the cornea and strengthens it simultaneously. 4) Corneal Allogenic Intrastromal Ring Segments (CAIRS), a newer technique using donor corneal tissue to create ring segments, offering a biological alternative to synthetic ICRS.

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Riboflavin

Corneal Cross-Linking for Keratoconus

Phase 3

Waitlist Available

Led By Nancy A Tanchel, MD

Research Sponsored by Crowd Health Research, LTD

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of progressive keratoconus with specific criteria including increase in steepest keratometry value, astigmatism, myopic shift, presence of steepening on topography map, axial topography consistent with keratoconus, and Kmax value ≥ 47.00 D

Must not have

Significant nystagmus or any condition preventing a steady gaze during treatment

Current condition interfering with or prolonging epithelial healing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a procedure called Corneal Cross Linking, which uses UV light and eye drops to strengthen the cornea. It is aimed at patients with weak corneas, like those with keratoconus. The study compares two methods of applying the treatment to see which is safer and more effective. Corneal cross-linking using riboflavin and ultraviolet A light has been widely adopted and refined to halt the progression of keratoconus.

Who is the study for?

This trial is for people 12 years or older with a condition called keratoconus, where the cornea (the clear front part of the eye) bulges out. They should have worsening vision as shown by certain measurements and be able to follow the study's visit schedule. Those who wear contact lenses must remove them before evaluation and treatment.

What is being tested?

The study is testing two methods of strengthening the cornea: one where a vitamin B solution (riboflavin) is applied with the outer layer of the cornea intact ('Epithelium-On'), and another method where this layer is removed first ('Epithelium-Off'). Both methods use UV light to activate riboflavin, either in continuous or pulsed beams.

What are the potential side effects?

Possible side effects include discomfort or pain in the eye, temporary blurry vision, swelling, infection risk increase, changes in corneal shape that could affect vision, and sensitivity to light.

Eligibility Criteria

Inclusion Criteria

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

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My eye condition, keratoconus, is getting worse.

Exclusion Criteria

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

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I do not have eye movements that prevent me from keeping a steady gaze.

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My condition is delaying skin or tissue healing.

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I have had a chemical injury or slow healing in my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Visual Acuity

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

4Treatment groups

Active Control

Group I: Epi-Off ContinuousActive Control2 Interventions

Continuous beam of UV light treating cornea without surface epithelium present

Group II: Epi-On ContinuousActive Control2 Interventions

Continuous beam of UV light treating cornea with surface epithelium present

Group III: Epi-Off PulsedActive Control2 Interventions

Pulsed beam of UV light treating cornea without surface epithelium present

Group IV: Epi-On PulsedActive Control2 Interventions

Pulsed beam of UV light treating cornea with surface epithelium present

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Corneal Cross-Linking (CXL) is a treatment for Keratoconus that involves applying riboflavin (vitamin B2) to the cornea and then exposing it to ultraviolet A (UVA) light. This process strengthens the collagen fibers in the cornea, making it more rigid and stable. This is particularly important for Keratoconus patients because the disease causes the cornea to thin and bulge, leading to distorted vision. By reinforcing the corneal structure, CXL can halt the progression of Keratoconus and improve visual outcomes.