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Crosslinking Agent
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution for Corneal Ectasia
Phase 1
Waitlist Available
Led By Tyrone McCall, MD
Research Sponsored by Cornea Associates of Texas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
8 years of age or older
Signed written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial found that the PXL-Platinum 330 System is safe and effective for corneal collagen cross-linking in eyes with corneal thinning conditions.
Eligible Conditions
- Pellucid Marginal Corneal Degeneration
- Corneal Ectasia
- Corneal Dystrophy
- Keratoconus
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are willing and able to comply with follow-up visits.
Select...
The corneal apex is not decentlyered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
K-Max
K-Mean
Secondary outcome measures
Best Corrected Visual Acuity
Central Pachymetry
Uncorrected Visual Acuity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pulsed 6mW/cm2Experimental Treatment1 Intervention
6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 minute total treatment time
Group II: Pulsed 4mW/cm2Experimental Treatment1 Intervention
4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 minute total treatment time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Riboflavin
FDA approved
Find a Location
Who is running the clinical trial?
Cornea Associates of TexasLead Sponsor
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Tyrone McCall, MDPrincipal InvestigatorCornea Associates of Texas
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Cornea Associates of Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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