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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)
Must not have
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
History of corneal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had an eye condition that could cause future problems.
Select...
I have had a corneal disease in the past.
Select...
I can keep my gaze steady during eye treatments and tests.
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I have had a chemical injury or slow healing in my eye.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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Who is running the clinical trial?
Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
953 Total Patients Enrolled
9 Trials studying Keratoconus
953 Patients Enrolled for Keratoconus
Peter Hersh, M.D.Principal InvestigatorCornea and Laser Eye Institute
2 Previous Clinical Trials
363 Total Patients Enrolled
1 Trials studying Keratoconus
92 Patients Enrolled for Keratoconus
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 21 years old or older.I have been diagnosed with keratoconus or corneal ectasia after having eye surgery like LASIK.My eye condition is related to keratoconus or corneal ectasia after surgery.I have had an eye condition that could cause future problems.I have had a corneal disease in the past.I can keep my gaze steady during eye treatments and tests.My current health condition could slow down my skin healing.I have had a chemical injury or slow healing in my eye.
Research Study Groups:
This trial has the following groups:- Group 1: Intacs combined with CXL
- Group 2: Intacs followed by CXL
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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