- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02009709
Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2
December 10, 2015 updated by: Robert Mack, M.D.
Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia
The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Robert J Mack, M.D.
- Phone Number: 847-755-9393
- Email: rjsmack@aol.com
Study Locations
-
-
Illinois
-
Hoffman Estates, Illinois, United States, 60169
- Recruiting
- Mack Eye Center
-
Contact:
- Adam Baruch
- Phone Number: 847-755-9393
- Email: adam@mackeyecenter.com
-
Principal Investigator:
- Robert J Mack, M.D.
-
Sub-Investigator:
- Monica Kurzawa, OD
-
Sub-Investigator:
- Puja Shah, OD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
General Inclusion Criteria
Prospective subjects must meet all of the following criteria to be eligible for participation:
- 18 years of age or older
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
- Contact lens removal prior to evaluation and treatment
Inclusion criteria for progressive keratoconus
Prospective subjects must meet two of the following criteria:
- Having a diagnosis of progressive keratoconus:
- An increase of ≥ 1.00 D in the steepest keratometry value
- An increase of ≥ 1.00 D in astigmatism manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Presence of central or inferior steepening on the Pentacam map.
- Axial topography consistent with keratoconus
- Steepest keratometry (Kmax) value ≥ 47.00 D
Inclusion criteria for ectasia
Prospective subjects must meet the following criteria:
- History of having undergone a keratorefractive procedure
- Meeting two of the following criteria
- Steepening by topography, either Pentacam or Humphrey
- Thinning of cornea
- Shift in the position of thinnest portion of cornea
- Change in refraction with increasing myopia
- Development of myopic astigmatism
- Development of irregular astigmatism
- Loss of best spectacle corrected acuity. 6.2 Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from this protocol:
- Eyes classified as either normal, atypical normal,
- Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye to be treated
- A history of chemical injury or delayed epithelial healing in the eye to be treated.
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment
- Inability to cooperate with diagnostic tests.
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 9 mW/cm2
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
|
Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.
Other Names:
Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
Other Names:
|
Active Comparator: 18 mW/cm2
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
|
Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.
Other Names:
Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in maximum corneal curvature
Time Frame: 3 and 6 months post-procedure
|
3 and 6 months post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert J Mack, M.D., Mack Eye Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 12, 2013
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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