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Procedure

Collagen Cross-Linking for Keratoconus

Mack Eye Center, Hoffman Estates, IL
Targeting 2 different conditionsRiboflavin 0.1% ophthalmic solution +2 morePhase 1Waitlist AvailableLed by Robert J Mack, M.D.Research Sponsored by Robert Mack, M.D.

Study Summary

This trial will test how effective and safe a corneal collagen cross-linking is at two different energy levels.

Eligible Conditions
  • Keratoconus
  • Corneal Ectasia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have had a type of eye surgery called keratorefractive procedure in the past.
Select...
Your cornea is too thin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months post-procedure for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Collagen Cross-Linking (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02009709 — Phase 1
Keratoconus Research Study Groups: 9 mW/cm2, 18 mW/cm2
Keratoconus Clinical Trial 2023: Collagen Cross-Linking Highlights & Side Effects. Trial Name: NCT02009709 — Phase 1
Collagen Cross-Linking (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02009709 — Phase 1
Keratoconus Patient Testimony for trial: Trial Name: NCT02009709 — Phase 1

Frequently Asked Questions

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

Is this research actively recruiting participants?

"According to clinicaltrials.gov, this trial has ceased recruiting participants, with the last update occurring on December 10th 2015. Nevertheless, a total of 92 other medical studies are currently looking for patients right now."

Answered by AI

What is the upper limit on enrollees for this clinical investigation?

"At present, this clinical trial is not seeking to enrol more participants. It was first listed in October 2013 before the most recent update on December 10th 2015. For those searching for related trials, there are 75 studies concerning keratoconus and 17 experiments involving 9 mW/cm2 that require additional patients."

Answered by AI

Have there been any studies that have utilized 9 mW/cm2 to date?

"Currently, of all the studies examining 9 mW/cm2, 8 are in Phase 3 with 17 trials still active. Furthermore, there is a total of 44 research centres conducting these investigations; the most being based out of San Francisco, Californiaf all the studies examining 9 mW/cm2, 8 are in Phase 3 with 17 trials still active. Furthermore, there is a total of 44 research centres conducting these investigations; the most being based out of San Francisco, California."

Answered by AI

Does a 9 mW/cm2 radiation exposure pose any health risks?

"Due to the limited clinical data on 9 mW/cm2, it was assigned a safety score of 1. This is expected as this trial currently only in Phase 1 and there is little evidence supporting its efficacy or safety."

Answered by AI

Who is authorized to partake in this clinical experiment?

"This clinical trial seeks 100 individuals of legal age and suffering from keratoconus. To be eligible, participants must demonstrate an aptitude for following the study's timeline, have recently removed their contact lenses, display a shift in myopia of at least 0.50 D on refraction testing, exhibit central or inferior steepening in Pentacam mapping results, as well as hold astigmatism measurements that reflect an increase of 1.00 D or more from manifest refraction tests."

Answered by AI

Does this research entail recruiting individuals aged 30 or older?

"All applicants to this clinical trial must meet the age requirements of 18 years or older and no more than 80 upon enrollment."

Answered by AI

What conditions are ameliorated by the application of 9 mW/cm2?

"9 mW/cm2 is a viable approach to address dietary deficiencies, nutrition-based treatments and joint discomfort."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Illinois
What site did they apply to?
Mack Eye Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Why did patients apply to this trial?

I would like to receive treatment to strengthen my cornea if possible. I have progressive KC in both eyes treated left in 2018 and needing treatment in right after condition worsening. Ideally help can keep me from further issues and help others dealing with my illness.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2
Robert Mack, M.D. 2013. "Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02009709.
All > Keratoconus
~9 spots leftby Nov 2024
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