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Procedure
Collagen Cross-Linking for Keratoconus
Phase 1
Waitlist Available
Led By Robert J Mack, M.D.
Research Sponsored by Robert Mack, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prospective subjects must meet two of the following criteria for progressive keratoconus: Axial topography consistent with keratoconus
Prospective subjects must meet the following criteria for ectasia: History of having undergone a keratorefractive procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months post-procedure
Awards & highlights
Study Summary
This trial will test how effective and safe a corneal collagen cross-linking is at two different energy levels.
Who is the study for?
This trial is for adults with progressive keratoconus, a condition where the cornea thins and bulges outward. Participants must have worsening vision or corneal shape changes and be able to follow the study schedule. Those with very thin corneas, healing issues, taking Vitamin C supplements close to treatment, pregnant or breastfeeding women, or those unable to stay still during treatment cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of strengthening the cornea using collagen cross-linking (CCL) with two different light intensities: 9 mW/cm2 and 18 mW/cm2. It involves applying Riboflavin solution to the eye and then using a special UV lamp on it.See study design
What are the potential side effects?
Potential side effects may include discomfort in the eye, temporary visual disturbances like blurriness or halos around lights, sensitivity to light, inflammation of the eye tissues, delayed healing of the cornea after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition matches keratoconus patterns.
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I have had eye surgery to correct my vision.
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I am 18 years old or older.
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My vision has worsened by at least half a diopter due to keratoconus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 6 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease in maximum corneal curvature
Trial Design
2Treatment groups
Active Control
Group I: 9 mW/cm2Active Control2 Interventions
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
Group II: 18 mW/cm2Active Control2 Interventions
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
Find a Location
Who is running the clinical trial?
Robert Mack, M.D.Lead Sponsor
Robert J Mack, M.D.Principal InvestigatorMack Eye Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had chemical eye injuries or slow healing in my eyes.My eye condition matches keratoconus patterns.I have had eye surgery to correct my vision.My cornea is thinner than normal.My vision isn't as good even with my best glasses.I am 18 years old or older.I can remove my contact lenses before evaluation and treatment.I have been diagnosed with progressive keratoconus.My vision has worsened by at least half a diopter due to keratoconus.My cornea's thinnest part has shifted position.My vision is getting worse, becoming more nearsighted.My eyes have developed irregular astigmatism.I can attend all scheduled follow-up visits.I have not taken Vitamin C supplements in the last week.I do not have nystagmus or any condition that affects my ability to maintain a steady gaze.I do not have a condition that slows down skin healing.I have had eye surgery to correct my vision.I am 18 years old or older.My condition is worsening keratoconus.My cornea is thinner than normal.My eye condition is diagnosed as keratoconus.
Research Study Groups:
This trial has the following groups:- Group 1: 9 mW/cm2
- Group 2: 18 mW/cm2
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Keratoconus Patient Testimony for trial: Trial Name: NCT02009709 — Phase 1
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