What is the mechanism of action of this treatment?

The PXL Platinum 330 System treats corneal ulcers by inducing corneal collagen crosslinking (CXL) through the application of riboflavin (vitamin B2) solution followed by exposure to UV-A light. This process strengthens the corneal tissue by increasing the tensile strength and diameter of collagen fibrils in the cornea. The riboflavin acts as a photosensitizer, which, when activated by UV-A light, forms new chemical bonds between collagen molecules, thereby stabilizing the corneal structure. This is crucial for patients with corneal ulcers as it helps to halt the progression of the ulcer, promotes healing, and reduces the risk of corneal perforation, ultimately preserving vision.

What side effects are associated with this type of intervention?

Common side effects of corneal collagen crosslinking (CXL) with riboflavin and UV-A light include transient corneal haze, temporary discomfort or pain, and epithelial defects that usually heal within a few days. There is also a risk of infection if proper post-operative care is not followed. In rare cases, patients may experience a decrease in corneal transparency or endothelial cell damage.

What prior FDA approvals exist?

The FDA has approved corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. This treatment involves the use of riboflavin (vitamin B2) eye drops and UV-A light to strengthen the corneal structure. The PXL Platinum 330 System, which combines riboflavin solution with UV-A light exposure, is being studied for its effectiveness in treating refractory corneal ulcers, leveraging the same principle of corneal collagen crosslinking to improve corneal biomechanical properties.

What other types of research exist?

Promising novel alternatives to the PXL Platinum 330 System for corneal ulcer treatment include: 1) Topical application of growth factors or cytokines to promote corneal healing, 2) Use of amniotic membrane transplantation to provide a biological scaffold for tissue regeneration, 3) Development of advanced drug delivery systems such as nanoparticle-based therapies to enhance the efficacy of antimicrobial and anti-inflammatory agents, and 4) Exploration of gene therapy techniques to address underlying genetic causes of corneal diseases.

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Procedure

Corneal Collagen Crosslinking for Corneal Ulcer

Phase 2 & 3

Recruiting

Led By Bala Ambati

Research Sponsored by Peschke GmbH

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Presence of a perforated corneal ulcer

Presence of a corneal ulcer deeper than 50% depth or 275 μm in the cornea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2 (#+/- 2 study days).

Awards & highlights

Summary

This trial is being done to see if the PXL Platinum 330 System is safe and effective for performing corneal collagen crosslinking for the treatment of refractory corneal ulcers.

Who is the study for?

Adults with a central corneal ulcer or hypopyon that hasn't improved after 24 hours of standard antibiotic eye drops, or hasn't fully healed within a week. Participants must be willing to have their cornea cultured for bacteria and follow the visit schedule. Their corneas must be thicker than 300 μm. Those with perforated ulcers, other active infections, previous serious ocular conditions, uncontrolled systemic diseases, pregnancy/lactation, known drug sensitivities, or very deep ulcers are excluded.Check my eligibility

What is being tested?

The trial is testing the PXL Platinum 330 System combined with riboflavin solution against a sham treatment using artificial tears. The system uses UV-A light and riboflavin to strengthen the cornea by inducing collagen crosslinking (CXL), which could help heal stubborn corneal ulcers.See study design

What are the potential side effects?

Potential side effects may include discomfort in the eye during treatment, sensitivity to light post-treatment, temporary vision changes or blurring due to the procedure itself. There's also a risk of infection from any invasive eye procedure.

Eligibility Criteria

Exclusion Criteria

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

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I have a hole in my cornea due to an ulcer.

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I have a deep corneal ulcer.

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I have an eye infection, but it's not in the center of the cornea or causing pus in the eye.

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I do not have an uncontrolled systemic disease affecting my cornea.

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I have a severe ulcer in my eye.

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I am suspected to have an eye infection needing special eye drops.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2 (#+/- 2 study days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2 (#+/- 2 study days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 (#+/- 2 study days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen CXL (performed using the PXL-Platinum 330 system with riboflavin solution) for treating refractory corneal ulcers.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard of care + CXL + Riboflavin 0.25% TE SolutionExperimental Treatment1 Intervention

Standard of care treatment and the experimental combination product. The PXL Platinum 330 Illumination System is a portable electronic medical device. The device's light emitting diode (LED) is used to deliver a metered dose of UV-A light to a targeted treatment area for illuminating the cornea during corneal collagen CXL. The riboflavin solution is an isotonic (0.9%) sodium chloride solution containing 0.25% riboflavin, 1% hydroxypropylmethylcellulose, and 0.007% benzalkonium chloride, adjusted to a pH of 7.0, and packaged in 2 mL sterile syringes for topical ophthalmic use.

Group II: Standard of care + Sham CXL + Artificial TearsPlacebo Group1 Intervention

Standard-of-care treatment and Sham CXL and administration of artificial tears.

0 / 6Eligibility 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

The PXL Platinum 330 System treats corneal ulcers by inducing corneal collagen crosslinking (CXL) through the application of riboflavin (vitamin B2) solution followed by exposure to UV-A light. This process strengthens the corneal tissue by increasing the tensile strength and diameter of collagen fibrils in the cornea. The riboflavin acts as a photosensitizer, which, when activated by UV-A light, forms new chemical bonds between collagen molecules, thereby stabilizing the corneal structure. This is crucial for patients with corneal ulcers as it helps to halt the progression of the ulcer, promotes healing, and reduces the risk of corneal perforation, ultimately preserving vision.

Increased resistance of crosslinked cornea against enzymatic digestion.