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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
Bacterial or fungal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of >25% corneal thickness
Vogt's striae
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 belowSelect...
My eye infection hasn't improved after 2 weeks of treatment or my cornea is quickly getting thinner.
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I have fine lines in my eye's cornea.
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My eye surgery involves specific measurements and conditions.
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My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
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I am 12 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor believes my condition won't delay skin healing.Your cornea is not centered properly.I have signs of keratoconus or pellucid marginal degeneration.I have removed my contact lenses as required before the eye test.My eye shows a bulging sign when looking down.My eye infection hasn't improved after 2 weeks of treatment or my cornea is quickly getting thinner.You do not have a specific physical sign called Rizzutti's sign.I have fine lines in my eye's cornea.You have a known allergy or sensitivity to the study medications.My eye surgery involves specific measurements and conditions.You have a condition called Fleisher ring.I have significant scarring on my cornea that is not due to keratoconus and may affect treatment.My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.I am 12 years old or older.I do not have any conditions like nystagmus that would prevent me from keeping my gaze steady.My eyes have conditions that could lead to future problems.I have a history of or currently have a corneal disease.The topography of the area being examined shows a crab-claw shape.
Research Study Groups:
This trial has the following groups:- Group 1: Pulsed Accelerated
- Group 2: Conventional
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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