Trial record 9 of 31 for:    Arnold-Chiari Malformation

Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

This study is currently recruiting participants.
Verified December 2013 by Mack Eye Center
Sponsor:
Information provided by (Responsible Party):
Robert Mack, M.D., Mack Eye Center
ClinicalTrials.gov Identifier:
NCT02009709
First received: December 9, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Keratoconus
Corneal Ectasia
Drug: Riboflavin 0.1% ophthalmic solution
Device: CCL-VARIO UV lamp
Device: CCL-VARIO at 18 mW/cm2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mack Eye Center:

Primary Outcome Measures:
  • Decrease in maximum corneal curvature [ Time Frame: 3 and 6 months post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 9 mW/cm2
CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
Drug: 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:
  • CXL
  • CCL
  • crosslinking
Device: CCL-VARIO UV lamp
Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
Other Names:
  • CXL
  • CCL
  • crosslinking
Active Comparator: 18 mW/cm2
CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
Drug: 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:
  • CXL
  • CCL
  • crosslinking
Device: 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 Names:
  • CXL
  • CCL
  • crosslinking

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009709

Contacts
Contact: Robert J Mack, M.D. 847-755-9393 rjsmack@aol.com

Locations
United States, Illinois
Mack Eye Center Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Adam Baruch    847-755-9393    adamb@occhicago.com   
Principal Investigator: Robert J Mack, M.D.         
Sub-Investigator: Kevin Ferenchak         
Sponsors and Collaborators
Robert Mack, M.D.
Investigators
Principal Investigator: Robert J Mack, M.D. Mack Eye Center
  More Information

No publications provided

Responsible Party: Robert Mack, M.D., Sponsor-Investigator, Mack Eye Center
ClinicalTrials.gov Identifier: NCT02009709     History of Changes
Other Study ID Numbers: MEC-0001
Study First Received: December 9, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mack Eye Center:
keratoconus
collagen crosslinking
crosslinking
ectasia

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Corneal Diseases
Pathological Conditions, Anatomical
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 22, 2014