← Back to Search

Procedure

Corneal Collagen Cross-Linking for Keratoconus

Phase 2
Recruiting
Research Sponsored by Eye Specialists of Indiana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as
Removal of contact lenses for the require period of time prior to the screening refraction:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether the Peschke PXL-330 is safe and effective in treating corneal thinning conditions.

Who is the study for?
This trial is for individuals aged 12 or older with corneal thinning conditions like keratoconus. They must have specific signs of these conditions, be willing to follow the visit schedule, and not wear contact lenses before screening. Pregnant women, lactating mothers, and those with certain eye diseases or sensitivities are excluded.Check my eligibility
What is being tested?
The PXL Platinum 330 System combined with Riboflavin is being tested for safety and effectiveness in treating corneal thinning disorders. The study will assess if this device can stabilize the condition by strengthening the cornea.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort during treatment, changes in vision, inflammation or infection risk post-treatment due to UV exposure from the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have signs of keratoconus or pellucid marginal degeneration.
Select...
I have removed my contact lenses as required before the eye test.
Select...
My eye shows a bulging sign when looking down.
Select...
My eye infection hasn't improved after 2 weeks of treatment or my cornea is quickly getting thinner.
Select...
I have fine lines in my eye's cornea.
Select...
My eye surgery involves specific measurements and conditions.
Select...
My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
Select...
I am 12 years old or older.

Timeline

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
30mW, 5 sec, 5 sec off, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea
Group II: ConventionalActive Control1 Intervention
9mW continuous, 10 minutes of illumination. Combination Product: PXL-330 Platinum device for cross linking with Peschke riboflavin solution will be used to load the cornea followed by UV-A cross linking of the cornea

Find a Location

Who is running the clinical trial?

Eye Specialists of IndianaLead Sponsor

Media Library

PXL 330 Platinum device/Riboflavin (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04213885 — Phase 2
Keratoconus Research Study Groups: Pulsed Accelerated, Conventional
Keratoconus Clinical Trial 2023: PXL 330 Platinum device/Riboflavin Highlights & Side Effects. Trial Name: NCT04213885 — Phase 2
PXL 330 Platinum device/Riboflavin (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04213885 — Phase 2
Keratoconus Patient Testimony for trial: Trial Name: NCT04213885 — Phase 2

Frequently Asked Questions

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

How many participants are involved in this research endeavor?

"Affirmative. According to the information located on clinicaltrials.gov, this medical study is actively looking for participants and was first published on May 4th 2020 with its most recent update occurring on August 16th 2021. This trial requires 300 volunteers from a single site to participate in it."

Answered by AI

Is the PXL 330 Platinum device/Riboflavin well-tolerated by humans?

"The safety of PXL 330 Platinum device/Riboflavin has been ranked as a 2, as this is currently in the Phase 2 trial stage. While there are some data points attesting to its security, no evidence supports its efficacy yet."

Answered by AI

Is enrollment still available for this experiment?

"Affirmative. According to the records on clinicaltrials.gov, this research project is actively seeking patients and was initially posted on May 4th 2020 with its most recent update occurring in August 2021. 300 people are expected to join from 1 location."

Answered by AI

What conditions can the PXL 330 Platinum device/Riboflavin be employed for?

"PXL 330 Platinum device/Riboflavin is often prescribed for dietary and nutritional therapies, as well as additional conditions such as vitamin deficiency, muscular discomfort, and inadequate vitamins."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
North Carolina
What site did they apply to?
Eye Specialists of Indiana
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I would like to do cross linking to stop the progression of my keratoconus.
PatientReceived 1 prior treatment
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

What questions have other patients asked about this trial?

How long a d how frequently would I need to be in Indiana?
PatientReceived 2+ prior treatments
~173 spots leftby Sep 2029