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CXL for Keratoconus

Phase 3
Recruiting
Research Sponsored by Rush Eye Associates
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am between the ages of 10 and 70.
Select...
I have been diagnosed with a corneal ectasia disorder.

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
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

CXL (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01708538 — Phase 3
Keratoconus Research Study Groups: Epithelium on, Epithelium off
Keratoconus Clinical Trial 2023: CXL Highlights & Side Effects. Trial Name: NCT01708538 — Phase 3
CXL (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01708538 — Phase 3

Frequently Asked Questions

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

Who can join this clinical trial?

"The aim of this study is to treat corneal ectasia disorders, such as keratoconus. To be eligible, patients must between the ages 10 and 70. Around 30 people will be accepted into the clinical trial."

Answered by AI

Are elderly patients being accepted for this clinical trial?

"This study is recruiting patients aged 10-70. If you are outside of that age bracket, there are 22 studies for people under 18 and 57 for people over 65."

Answered by AI

Has Epithelium undergone FDA approval process yet?

"There is some clinical data that suggests Epithelium is effective and multiple rounds of safety trials have been conducted, so it received a score of 3."

Answered by AI

Are there any available slots for participants in this trial?

"Yes, this information can be found on clinicaltrials.gov. The study was posted on October 1st, 2012 and has been actively recruiting since then with the most recent edit taking place on October 24th, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Rush Eye Associates
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

What would be the cost?
PatientReceived no prior treatments

Why did patients apply to this trial?

I do not have the money right now to pay for cross linking. I also do not have insurance right now.
PatientReceived 1 prior treatment
~1 spots leftby Oct 2024