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Corneal Cross-Linking Comparing Variables

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Crowd Health Research, LTD.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Crowd Health Research, LTD
ClinicalTrials.gov Identifier:
NCT02095730
First received: March 20, 2014
Last updated: March 21, 2014
Last verified: March 2014
  Purpose
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.

Condition Intervention Phase
Unstable Corneas
Drug: Epithelium-On Riboflavin
Drug: Epithelium-Off Riboflavin
Device: UV Light - Continuous Beam
Device: UV Pulsed Beam
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Safety and Efficacy of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 as Constant or Pulsed Treatment in Eyes With Unstable Corneas Due to Keratoconus, Ectasia, or Post-Incisional Refractive Surgery

Resource links provided by NLM:


Further study details as provided by Crowd Health Research, LTD:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Uncorrected visual acuity


Estimated Enrollment: 500
Study Start Date: May 2014
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epi-On Continuous
Continuous beam of UV light treating cornea with surface epithelium present
Drug: Epithelium-On Riboflavin
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
Other Name: Vitamin B2
Device: UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
Other Name: Peschke Vario CCL-365 UV system
Active Comparator: Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
Drug: Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
Other Name: Vitamin B2
Device: UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
Other Name: Peschke Vario CCL-365 UV system
Active Comparator: Epi-On Pulsed
Pulsed beam of UV light treating cornea with surface epithelium present
Drug: Epithelium-On Riboflavin
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
Other Name: Vitamin B2
Device: UV Pulsed Beam
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Other Name: Peschke Vario CCL-365 UV system
Active Comparator: Epi-Off Pulsed
Pulsed beam of UV light treating cornea without surface epithelium present
Drug: Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
Other Name: Vitamin B2
Device: UV Pulsed Beam
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Other Name: Peschke Vario CCL-365 UV system

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Keratoconus:

  • 12 years of age or older
  • Having a clinical diagnosis of progressive keratoconus consistent with:

    1. An increase of ≥ 1.00 D in the steepest keratometry value
    2. An increase of ≥ 1.00 D in astigmatism manifest refraction
    3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
  • Presence of central or inferior steepening on the topography map.
  • Axial topography consistent with keratoconus
  • Steepest keratometry (Kmax) value ≥ 47.00 D
  • 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 Post-Surgical Ectasia:

  • History of having undergone a keratorefractive procedure and:

    1. Steepening by topography
    2. Thinning of cornea
    3. Shift in the position of thinnest portion of cornea
    4. Change in refraction with increasing myopia
    5. Development of myopic astigmatism
    6. Development of irregular astigmatism
    7. Loss of Best Spectacle Corrected Visual Acuity
  • At least two of the above criteria must be present.

Inclusion Criteria Intacts:

  • Should the patient have undergone prior Intacs or other intra-corneal ring segment surgery for keratoconus or post-surgical ectasia at least 6 months prior, and is also experiencing at least two of the above ectasia symptoms, they can be included in the study.

    1. These patients would have the choice of ring explant before Cross-Linking.
    2. Cross-Linking may still be performed if the patient wishes to retain the rings.
  • Should a patient's situation due to factors such as significantly high myopia or astigmatism should warrant simultaneous placement of Intacs and cross-linking in the investigators opinion, then this option can be offered to the patient. Such interventions would be tracked as a different arm of the study.

Inclusion Criteria RK/AK Fluctuation:

  • History of having undergone radial keratotomy (RK) and or astigmatic keratotomy (AK) surgery.
  • Expressing complaints about difficulties due to vision changing during the same day.
  • A difference in their Manifest Refraction (MRx) of greater than 0.75 D measured on the same day, at least 6 hours apart.
  • Intacs surgery will not be considered in patients with RK/AK.

Exclusion Criteria:

  • Eyes classified as either normal, atypical normal,
  • Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
  • A history of chemical injury or delayed epithelial healing in the eye to be treated.
  • A known sensitivity to study medications
  • Patients with significant 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 comfortable and stable, and tolerate a lid speculum for the appointed period of time for the procedure.
  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: NCT02095730

Locations
United States, California
LaserVue Eye
Santa Rosa, California, United States, 95403
United States, Colorado
Icon Lasik
Denver, Colorado, United States, 80210
United States, Florida
Gulani Vision Institute
Jacksonville, Florida, United States, 32216
United States, Georgia
Eye Consultants of Atlanta
Atlanta, Georgia, United States, 30339
United States, Illinois
Midwest Center for Sight
Des Plaines, Illinois, United States, 60016
Bond Eye Associates
Pekin, Illinois, United States, 61554
United States, Kansas
Discover Vision Center
Leawood, Kansas, United States, 66211
United States, Mississippi
Southern Eye Center
Hattiesburg, Mississippi, United States, 39402
United States, Missouri
Mercy Clinic Eye Specialists
Springfield, Missouri, United States, 65807
United States, Nevada
LASIK of Nevada
Las Vegas, Nevada, United States, 89123
United States, Pennsylvania
James Lewis MD PC
Elkins Park, Pennsylvania, United States, 19027
Memorial Eye Institute
Harrisburg, Pennsylvania, United States, 17112
United States, South Carolina
Carolina Eye Care
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Loden Vision Centers
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Parkhurst NuVision
San Antonio, Texas, United States, 78229
United States, Virginia
Liberty Laser Eye Center
Vienna, Virginia, United States, 22182
Sponsors and Collaborators
Crowd Health Research, LTD
Investigators
Principal Investigator: Nancy A Tanchel, MD Liberty Laser Eye Center
  More Information

Responsible Party: Crowd Health Research, LTD
ClinicalTrials.gov Identifier: NCT02095730     History of Changes
Other Study ID Numbers: CXL-CHR 1 
Study First Received: March 20, 2014
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Crowd Health Research, LTD:
crosslinking
cornea
keratoconus
ectasia
irradiance
riboflavin

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Vitamins
Riboflavin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on December 05, 2016