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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 10-70
Diagnosis of corneal ectasia disorder
Must not have
Unwilling or unable to participate in trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial looks at different ways of doing a corneal cross-linking treatment to see which is better for treating corneal dystrophies.
Who is the study for?
This trial is for people aged 10-70 with a corneal condition called ectasia, which includes keratoconus. Participants must be willing to join the study.
What is being tested?
The study tests corneal collagen cross-linking (CXL), a treatment for strengthening the cornea in patients with conditions like keratoconus, using different surgical techniques.
What are the potential side effects?
Possible side effects of CXL may include temporary eye pain and discomfort, blurred vision, risk of infection, and rarely, permanent changes in vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between the ages of 10 and 70.
Select...
I have been diagnosed with a corneal ectasia disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing or able to participate in the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Keratometry measurements
Visual acuity
Trial Design
2Treatment groups
Active Control
Group I: Epithelium onActive Control1 Intervention
Epi not removed during CXL treatment
Group II: Epithelium offActive Control1 Intervention
Epi removed before CXL treatment
Find a Location
Who is running the clinical trial?
Rush Eye AssociatesLead Sponsor
6 Previous Clinical Trials
971 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between the ages of 10 and 70.You are willing to take part in the study.I am not willing or able to participate in the trial.I have been diagnosed with a corneal ectasia disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Epithelium on
- Group 2: Epithelium off
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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