What side effects are associated with this type of intervention?

Corneal crosslinking (CXL) for keratoconus, which uses riboflavin and UVA light, is generally safe but can have side effects. Common side effects include transient eye pain, corneal haze, and temporary vision disturbances. Less frequently, patients may experience corneal infections, delayed epithelial healing, and endothelial cell damage. It is important to discuss these potential risks with an ophthalmologist to make an informed decision.

What prior FDA approvals exist?

The FDA has approved corneal crosslinking for the treatment of progressive keratoconus. This procedure involves the use of riboflavin (vitamin B2) eye drops and UVA light to strengthen the collagen fibers in the cornea, thereby stabilizing the condition and preventing further deterioration. The specific products approved for this purpose include the Photrexa Viscous, Photrexa, and the KXL System. These treatments aim to halt the progression of keratoconus and improve corneal stability.

What other types of research exist?

Promising novel alternatives to corneal crosslinking for keratoconus patients include: 1) Intrastromal corneal ring segments (ICRS) which are implants that help flatten the cornea and improve vision. 2) Topography-guided photorefractive keratectomy (PRK) combined with corneal crosslinking, which reshapes the cornea and strengthens it simultaneously. 3) Customized corneal collagen crosslinking protocols that use different wavelengths or intensities of light to optimize treatment outcomes. 4) Gene therapy approaches targeting the underlying genetic causes of keratoconus, though these are still in experimental stages.

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Crosslinking Agent

Standard vs. Accelerated Corneal Crosslinking for Keratoconus

Phase 2 & 3

Recruiting

Led By Francis W Price, Jr., MD

Research Sponsored by Price Vision Group

Eligibility Criteria Checklist

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

Must have

Documented keratoconus or ectasia after refractive surgery

Must not have

History of chemical injury or delayed epithelial healing

Insufficient corneal thickness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial compares two methods of corneal crosslinking, a procedure that strengthens the cornea using special eye drops and light. It targets people with progressive keratoconus or corneal ectasia, conditions where the cornea weakens and bulges out. The treatment aims to make the cornea more stable and prevent further vision problems. Corneal crosslinking (CXL) has become the standard treatment for rapidly progressing keratoconus.

Who is the study for?

This trial is for people with progressive keratoconus or corneal ectasia after refractive surgery. It's not suitable for those with conditions affecting eye healing, a history of chemical injury or slow healing, known sensitivity to the medications used in the study, pregnant individuals, those with thin corneas, or other ocular conditions that could complicate treatment.

What is being tested?

The trial aims to compare two methods of corneal crosslinking: accelerated and standard. Both use riboflavin (vitamin B2) drops but differ in how quickly UV light is applied to strengthen the cornea and halt progression of keratoconus or ectasia.

What are the potential side effects?

Potential side effects may include discomfort during treatment, temporary vision changes like haziness, risk of infection due to eye surface disruption during procedure, and delayed recovery leading to prolonged blurry vision.

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 had corneal thinning after eye surgery.

Exclusion Criteria

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

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I have had a chemical injury or slow healing of skin.

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My corneas are too thin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Change in maximum keratometry

Secondary study objectives

Change in corrected distance visual acuity

Change in uncorrected distance 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.

Trial Design

2Treatment groups

Active Control

Group I: AcceleratedActive Control1 Intervention

Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes

Group II: StandardActive Control1 Intervention

Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes

0 / 3Eligibility 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 Crosslinking (CXL) is a primary 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, increasing its rigidity and halting the progression of the disease. For Keratoconus patients, this treatment is essential as it can prevent further corneal thinning and deformation, thereby preserving vision and reducing the need for more invasive procedures like corneal transplants.