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Crosslinking Agent

Corneal Collagen Cross-Linking for Keratoconus

Phase 1
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
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
I am having eye surgery and my eye measurements meet specific criteria.
My eye infection hasn't improved after 2 weeks of treatment or my cornea is quickly getting thinner.
I have streaks in the eye's clear covering.
My AvaGen test shows I'm at high risk for keratoconus.
I am 12 years old or older.


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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean keratometry in diopters
Secondary outcome measures
Best corrected visual acuity

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
Bacterial Keratitis 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
Bacterial Keratitis Research Study Groups: Conventional, Pulsed, accelerated
Bacterial Keratitis Patient Testimony for trial: Trial Name: NCT03918408 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with Peschke ribofflavin solution and PXL-330 Platinum device crosslinking?

"The safety of the PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution is estimated at a 1 due to its Phase 1 clinical trial status; This indicates that only limited data exists in support of efficacy and safety."

Answered by AI

How many participants are currently taking part in this medical experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this investigation is currently recruiting participants with an initial posting date of September 1st 2019 and a recent update occurring on September 14th 2021. In total, 300 patients are needed at one medical centre for the study's completion."

Answered by AI

Does this trial include participants older than thirty years?

"According to the trial's stipulations, potential participants need to be between 10 and 45 years old."

Answered by AI

Who is authorized to partake in this scientific experiment?

"This clinical trial is seeking 300 patients with keratoconus aged 10 to 45. To be eligible for the study, applicants must possess an unstable form of the condition."

Answered by AI

Are there any vacancies for those interested in joining this experiment?

"Affirmative, according to clinicaltrials.gov this research study is still looking for participants. It was first advertised on September 1st 2019 and last updated two years later on September 14th 2021. 300 volunteers are needed from a single site."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Pacific Clear Vision Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have progressive KC in both eyes treated left in 2018 and needing treatment in right after condition worsening. Ideally help can keep me from further issues and help others dealing with my illness.
PatientReceived 2+ prior treatments
~154 spots leftby Jun 2029