What side effects are associated with this type of intervention?

Corneal cross-linking (CXL) for keratoconus, which involves the use of ultraviolet light and riboflavin, is generally considered safe but can have several side effects. Common side effects include transient eye pain, corneal haze, and epithelial defects. Patients may also experience temporary vision disturbances such as blurriness or light sensitivity. In rare cases, more severe complications like corneal infections, scarring, or endothelial cell damage can occur. It is important for patients to discuss these potential risks with their ophthalmologist to make an informed decision.

What prior FDA approvals exist?

The FDA has approved corneal cross-linking (CXL) for the treatment of Keratoconus, which involves the use of ultraviolet (UV) light and riboflavin (vitamin B2) to strengthen the corneal collagen fibers. This procedure, known as epithelium-off CXL, was first approved in 2016 under the brand names Avedro's Photrexa Viscous, Photrexa, and the KXL System. These treatments aim to halt the progression of Keratoconus by increasing the biomechanical stability of the cornea.

What other types of research exist?

Promising novel alternatives to the PXL Platinum 330 system for Keratoconus treatment include: 1) Customized corneal cross-linking (CXL) which tailors the UV light pattern to the patient's specific corneal topography, potentially improving outcomes. 2) Accelerated CXL, which reduces treatment time by using higher intensity UV light. 3) Epithelium-on (epi-on) CXL, which preserves the corneal epithelium, reducing discomfort and recovery time. 4) Intrastromal corneal ring segments (ICRS), which are implants that reshape the cornea and improve vision. 5) Corneal collagen cross-linking combined with photorefractive keratectomy (PRK), which not only strengthens the cornea but also corrects refractive errors.

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Procedure

Corneal Cross-Linking for Keratoconus

Phase 2

Recruiting

Research Sponsored by Goodman Eye Center

Eligibility Criteria Checklist

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

Must have

Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

10 years of age or older

Must not have

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 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called the PXL Platinum 330 system, which uses a special light treatment to strengthen the cornea. It targets patients with conditions that weaken and misshape the cornea, such as progressive keratoconus and pellucid marginal degeneration. The treatment works by creating new connections between the fibers in the cornea, helping it stay strong and maintain its shape.

Who is the study for?

This trial is for individuals with corneal ectasia conditions like keratoconus, showing specific signs such as Fleischer ring or Vogt's striae. Candidates must be 10 years or older and have a minimum corneal thickness. Those with previous significant eye diseases, less than required corneal thickness, or women who are pregnant/lactating cannot participate.

What is being tested?

The PXL Platinum 330 system paired with Peschke riboflavin solution is being tested for its safety and effectiveness in treating ectatic disorders by strengthening the cornea through cross-linking.

What are the potential side effects?

Potential side effects may include discomfort in the eye, temporary vision changes, risk of infection, inflammation inside the eye, and possible delayed healing of the treated area.

Eligibility Criteria

Inclusion Criteria

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

Select...

My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.

Select...

I am at least 10 years old.

Exclusion Criteria

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

Select...

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 ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 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

Best-contact corrected visual acuity (BSCVA)

Secondary study objectives

Keratometry

Uncorrected visual acuity

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pusled, acceleratedExperimental Treatment1 Intervention

8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Group II: Pulsed, acceleratedExperimental Treatment1 Intervention

4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platinum

Not yet FDA approved

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 cross-linking (CXL) is a common treatment for Keratoconus that uses ultraviolet (UV) light and riboflavin (vitamin B2) to strengthen the collagen fibers in the cornea. This treatment increases the biomechanical stability of the cornea, halting the progression of Keratoconus, which is characterized by thinning and bulging of the cornea. By reinforcing the corneal structure, CXL helps maintain corneal shape and improves visual acuity, which is crucial for Keratoconus patients to preserve their vision and quality of life.