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Corneal Collagen Crosslinking + Intacs for Keratoconus (CXL Trial)

Phase 3
Waitlist Available
Led By Peter Hersh, M.D.
Research Sponsored by Cornea and Laser Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
21 years of age or older
Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

CXL Trial Summary

This trial will compare two procedures for treating keratoconus, a degenerative eye disease. One procedure uses a collagen crosslinking, while the other uses Intacs. The goal is to determine which procedure is more effective.

Who is the study for?
This trial is for adults over 21 with keratoconus or corneal ectasia, not perfect vision (worse than 20/20), and specific topography changes. It's not for those with other eye conditions that could complicate treatment, thin corneas at certain measurements, pregnant or lactating individuals, known drug sensitivities, or healing issues.Check my eligibility
What is being tested?
The study tests the effectiveness of combining two treatments—corneal collagen crosslinking (CXL) and Intacs inserts—for keratoconus and corneal ectasia. One group receives both treatments in one session; another has CXL three months after Intacs to compare results.See study design
What are the potential side effects?
Potential side effects may include discomfort in the eye, visual disturbances like halos or glare, dry eyes, infection risk increase post-procedure. The severity can vary from person to person.

CXL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
Select...
I have been diagnosed with keratoconus or corneal ectasia after having eye surgery like LASIK.
Select...
My eye condition is related to keratoconus or corneal ectasia after surgery.

CXL Trial 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
Maximum keratometry
Secondary outcome measures
Best Corrected Visual Acuity

CXL Trial Design

2Treatment groups
Active Control
Group I: Intacs combined with CXLActive Control1 Intervention
Intacs placement followed by collagen crosslinking with UV light and riboflavin
Group II: Intacs followed by CXLActive Control1 Intervention
Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later

Find a Location

Who is running the clinical trial?

Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
953 Total Patients Enrolled
Peter Hersh, M.D.Principal InvestigatorCornea and Laser Eye Institute
2 Previous Clinical Trials
363 Total Patients Enrolled

Media Library

Corneal Collagen Crosslinking (CXL) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01112072 — Phase 3
Corneal Ectasia Research Study Groups: Intacs combined with CXL, Intacs followed by CXL
Corneal Ectasia Clinical Trial 2023: Corneal Collagen Crosslinking (CXL) Highlights & Side Effects. Trial Name: NCT01112072 — Phase 3
Corneal Collagen Crosslinking (CXL) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01112072 — Phase 3

Frequently Asked Questions

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

Do the benefits of Intacs and CXL outweigh any risks for patients?

"Intacs combined with CXL is rated as a 3 on our Power team's safety scale. This is due to the fact that it is a Phase 3 trial, which means there is some evidence of its efficacy and multiple rounds of data supporting its safety."

Answered by AI

What is the common reason that people take Intacs in combination with CXL?

"Using a combination of Intacs and CXL, patients can see improvement in dietary and nutritional therapies, vitamin deficiency, and joint pain."

Answered by AI

How many people are eligible for this clinical trial?

"This study is no longer recruiting participants. The listing was created on 4/1/2010 and most recently updated on 3/7/2022. For those seeking other trials, there are currently 90 trials actively recruiting patients with keratoconus and 20 for Intacs combined with CXL."

Answered by AI

Are there any other notable studies that have looked at Intacs in tandem with CXL?

"20 clinical studies are actively researching the efficacy of Intacs in conjunction with CXL. The majority of these trials, 11 in total, are currently in Phase 3. However, there are 47 active trial locations for Intacs combined with CXL across the globe—not just San Francisco, California."

Answered by AI

Are we still able to enroll patients in this experiment?

"Unfortunately, this study is no longer looking for participants. The clinical trial was originally advertised on April 1st 2010 and received its last update on March 7th 2022. However, there are other ongoing trials that may be of interest; including 90 studies searching for patients with keratoconus and 20 Intacs combined with CXL studies still recruiting individuals."

Answered by AI

Who else is applying?

What state do they live in?
Utah
How old are they?
18 - 65
What site did they apply to?
Cornea and Laser Eye Institute
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Dec 2024