What side effects are associated with this type of intervention?

Corneal Collagen Crosslinking (CXL) for Keratoconus is generally well-tolerated but can have some side effects. Common side effects include transient corneal haze, which usually resolves over time, and discomfort or pain in the initial days following the procedure. There may also be a temporary reduction in visual acuity and increased sensitivity to light. In rare cases, more severe complications such as corneal infection or scarring can occur. It is important for patients to follow post-procedure care instructions and attend follow-up appointments to monitor healing and manage any adverse effects.

What prior FDA approvals exist?

The FDA has approved Corneal Collagen Crosslinking (CXL) for the treatment of progressive Keratoconus. This procedure involves the use of riboflavin (vitamin B2) and ultraviolet A (UVA) light to strengthen the collagen fibers in the cornea, thereby stabilizing the corneal structure and halting the progression of the disease. The specific FDA-approved treatment is known as the KXL System, which uses riboflavin ophthalmic solution (Photrexa Viscous and Photrexa) in combination with the KXL System for UVA irradiation.

What other types of research exist?

Promising novel alternatives to Corneal Collagen Crosslinking for Keratoconus patients include: 1) Intrastromal corneal ring segments (ICRS), which are implants that help flatten the cornea and improve vision. 2) Topical treatments like riboflavin combined with other agents to enhance corneal strength. 3) Customized contact lenses, such as scleral lenses, which provide better vision correction and comfort. 4) Gene therapy approaches targeting the underlying genetic causes of keratoconus. 5) Advanced laser treatments, including topography-guided photorefractive keratectomy (PRK) combined with CXL, to reshape and stabilize the cornea.

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Corneal Collagen Crosslinking for Keratoconus

Phase 3

Waitlist Available

Led By Peter Hersh, MD

Research Sponsored by Cornea and Laser Eye Institute

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Be older than 18 years old

Must not have

Clinically significant corneal scarring in the CXL treatment zone

Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a treatment that uses UV light and vitamin B2 to strengthen weak or misshapen corneas in patients with keratoconus or post-surgery ectasia. The treatment works by creating new bonds in the cornea, making it more stable. This method has been widely adopted and refined to treat progressive keratoconus by increasing the strength of the cornea.

Who is the study for?

This trial is for adults over 18 with progressive keratoconus or corneal ectasia, whose vision isn't fully corrected to 20/20 with lenses. Their cornea must be thicker than 300 microns. It's not for those sensitive to the study drugs, have certain eye conditions, are pregnant/lactating, can't keep a steady gaze during treatment, or have other risks as assessed by the investigator.

What is being tested?

The trial tests two types of corneal collagen crosslinking (CXL) treatments using Hypotonic Riboflavin and Riboflavin/Dextran in patients with keratoconus or ectasia. The goal is to see if maintaining corneal thickness improves the consistency and predictability of CXL outcomes.

What are the potential side effects?

Potential side effects may include changes in vision, discomfort in the eye, swelling or inflammation of the cornea, infection risk increase due to epithelial healing delay after treatment.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

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

Select...

I have noticeable scarring on my cornea where I received CXL treatment.

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I do not have conditions like nystagmus that make it hard to keep my gaze steady.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

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

Corneal thickness

Secondary study objectives

Endothelial Cell Density

Manifest Refraction

Maximum Keratometry

+1 more

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: Riboflavin/dextranActive Control1 Intervention

Administration of Riboflavin/dextran every 2 minutes for the duration of UV exposure.

Group II: Hypotonic RiboflavinActive Control1 Intervention

Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure.

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 collagen crosslinking (CXL) is a common treatment for keratoconus that works by strengthening the collagen fibers in the cornea. This is achieved through the application of riboflavin (vitamin B2) eye drops, followed by exposure to ultraviolet A (UVA) light. The interaction between riboflavin and UVA light induces the formation of new cross-links between collagen fibers, increasing the cornea's rigidity and stability. This is crucial for keratoconus patients as it helps to halt the progression of the disease, reduce corneal steepness, and maintain better vision, thereby preventing further deterioration that could lead to severe visual impairment or the need for corneal transplantation.