Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2
NCT ID: NCT02009709
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
100 participants
INTERVENTIONAL
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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9 mW/cm2
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
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.
CCL-VARIO UV lamp
Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
18 mW/cm2
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
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.
CCL-VARIO at 18 mW/cm2
Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.
Interventions
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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.
CCL-VARIO UV lamp
Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
CCL-VARIO at 18 mW/cm2
Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
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
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Robert Mack, M.D.
OTHER
Responsible Party
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Robert Mack, M.D.
Sponsor-Investigator
Principal Investigators
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Robert J Mack, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mack Eye Center
Locations
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Mack Eye Center
Hoffman Estates, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Adam Baruch
Role: primary
Other Identifiers
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MEC-0001
Identifier Type: -
Identifier Source: org_study_id