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Crosslinking Agent

Corneal Collagen Cross-Linking for Keratoconus

Phase 1
Recruiting
Led By BALAMURALI AMBATI, MD, PhD
Research Sponsored by Pacific Clear Vision Institute
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
Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
Must not have
History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
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

Summary

This trial is testing a new system to treat corneal thinning conditions to see if it is safe and effective.

Who is the study for?
This trial is for people aged 12 or older with certain corneal thinning conditions like keratoconus, who haven't improved after two weeks of standard treatment for bacterial/fungal keratitis. Candidates must have specific signs of corneal disease and be willing to follow the study schedule. Pregnant individuals, those planning pregnancy, lactating, or with a history of certain eye diseases are excluded.
What is being tested?
The trial tests the safety and effectiveness of the PXL-330 Platinum device paired with Peschke riboflavin solution in treating corneal thinning disorders. It aims to see if this combination can strengthen the cornea by cross-linking its collagen fibers.
What are the potential side effects?
Potential side effects may include discomfort during treatment, temporary visual disturbances, inflammation or infection risk post-treatment. Long-term risks could involve changes in vision that might require corrective lenses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
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I am having eye surgery and my eye measurements meet specific criteria.
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My eye infection hasn't improved after 2 weeks of treatment or my cornea is quickly getting thinner.
Select...
I have streaks in the eye's clear covering.
Select...
My AvaGen test shows I'm at high risk for keratoconus.
Select...
I am 12 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of or currently have a corneal disease.
Select...
I don't have conditions like nystagmus that make it hard to keep my gaze steady.

Timeline

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
Mean keratometry in diopters
Secondary study objectives
Best corrected 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
Active Control
Group I: Pulsed, acceleratedExperimental Treatment1 Intervention
18 mW, 5 sec, 5 sec off, 10 minutes of illumination
Group II: ConventionalActive Control1 Intervention
9 mW, continuous 10 minutes of illumination

Find a Location

Who is running the clinical trial?

Pacific Clear Vision InstituteLead Sponsor
BALAMURALI AMBATI, MD, PhDPrincipal InvestigatorPCVI

Media Library

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution (Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03918408 — Phase 1
Keratoconus Clinical Trial 2023: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution Highlights & Side Effects. Trial Name: NCT03918408 — Phase 1
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution (Crosslinking Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03918408 — Phase 1
Keratoconus Research Study Groups: Conventional, Pulsed, accelerated
Keratoconus Patient Testimony for trial: Trial Name: NCT03918408 — Phase 1
~146 spots leftby Dec 2029
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