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. (see Contacts and Locations)
Verified April 2014 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: April 30, 2014
Last verified: April 2014
  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: January 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Monica Denny, OD         
Sub-Investigator: Puja Shah, OD         
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: April 30, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014