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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 1 year
Awards & highlights
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 belowSelect...
My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.
Select...
I am having eye surgery and my eye measurements meet specific criteria.
Select...
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 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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known sensitivity or allergy to the medications used in the study.My eye condition is related to keratoconus, surgery complications, or pellucid marginal degeneration.You have a condition called Fleischer ring.My eye shows a bulging sign when looking down.My eye can focus on a close object when covered.I have a history of or currently have a corneal disease.Your cornea is not centered properly.I am having eye surgery and my eye measurements meet specific criteria.I have removed my contact lenses as instructed before the eye test.The topography shows a crab-claw shape.My doctor thinks my condition could slow down my skin healing.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.I have significant scarring on my cornea that is not due to keratoconus and may affect treatment.My AvaGen test shows I'm at high risk for keratoconus.I meet the specific eye condition criteria for this study.I don't have conditions like nystagmus that make it hard to keep my gaze steady.My eyes have conditions that could risk future complications.I am 12 years old or older.I have signs of keratoconus or pellucid marginal degeneration.You can keep wearing your scleral lenses during the study, unless your eyes show signs of low oxygen levels, like new blood vessels forming on your cornea.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional
- Group 2: Pulsed, accelerated
Bacterial Keratitis Patient Testimony for trial: Trial Name: NCT03918408 — Phase 1
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