Corneal Cross-Linking Comparing Variables

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Crowd Health Research, LTD
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
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

Contacts
Contact: Travis A Johnson, Bachelor's 571-234-5678 ext 104 tjohnson@libertylasereye.com
Contact: Nancy A Tanchel, MD 571-234-5678 ext 103 ntanchel@libertylasereye.com

Locations
United States, California
LaserVue Eye Not yet recruiting
Santa Rosa, California, United States, 95403
Contact: Jay Bansal, MD    707-522-6200    bansal@laservue.com   
Principal Investigator: Jay Bansal, MD         
United States, Colorado
Icon Lasik Not yet recruiting
Denver, Colorado, United States, 80210
Contact: Richard Anderson, OD    720-524-1001    ra@icondenver.com   
Principal Investigator: Douglas Campbell, DO         
United States, Florida
Gulani Vision Institute Not yet recruiting
Jacksonville, Florida, United States, 32216
Contact: Arun Gulani, MD    904-296-7393    gulanivision@gulani.com   
Principal Investigator: Arun Gulani, MD         
United States, Georgia
Eye Consultants of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30339
Contact: Teresa Long    404-351-2220    teresa_long@eyeconsultants.net   
Principal Investigator: W. Barry Lee, MD         
United States, Illinois
Midwest Center for Sight Not yet recruiting
Des Plaines, Illinois, United States, 60016
Contact: James Katz, MD    847-824-3127    jamesakatz@aol.com   
Principal Investigator: James Katz, MD         
Bond Eye Associates Not yet recruiting
Pekin, Illinois, United States, 61554
Contact: William Bond, MD    309-353-6660    pekineye@yahoo.com   
Principal Investigator: William Bond, MD         
United States, Kansas
Discover Vision Center Not yet recruiting
Leawood, Kansas, United States, 66211
Contact: Misty Robe, Associate's    816-478-1230    mrobe@discovervision.com   
Principal Investigator: John Doane, MD         
United States, Mississippi
Southern Eye Center Not yet recruiting
Hattiesburg, Mississippi, United States, 39402
Contact: Cameron Griffith, MD    318-464-0306    csgriff1@earthlink.net   
Principal Investigator: Cameron Griffith, MD         
United States, Missouri
Mercy Clinic Eye Specialists Not yet recruiting
Springfield, Missouri, United States, 65807
Contact: Stephanie Sekscinski    417-820-9393    stephanie.sekscinski@mercy.net   
Principal Investigator: Shachar Tauber, MD         
United States, Nevada
LASIK of Nevada Not yet recruiting
Las Vegas, Nevada, United States, 89123
Contact: Valerie Serett    702-636-2010    vserette@yahoo.com   
Principal Investigator: Richard Rothman, MD         
Sub-Investigator: Rajy Rouweyha, MD         
United States, Pennsylvania
James Lewis MD PC Not yet recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: James Lewis, MD    215-886-9090    jslewis@jameslewis.com   
Principal Investigator: James Lewis, MD         
Memorial Eye Institute Not yet recruiting
Harrisburg, Pennsylvania, United States, 17112
Contact: Sherrie Reed    717-657-2020    crosslinkstudy@memorialeye.com   
Principal Investigator: Bennett Chotiner, MD         
Principal Investigator: Erik Chotiner, MD         
United States, South Carolina
Carolina Eye Care Not yet recruiting
Mt. Pleasant, South Carolina, United States, 29464
Contact: Helga Sandoval, MD    843-881-3937    helga.sandoval@carolinaeyecare.com   
Principal Investigator: Kerry Solomon, MD         
Sub-Investigator: Charlene Grice, MD         
United States, Tennessee
Loden Vision Centers Not yet recruiting
Goodlettsville, Tennessee, United States, 37072
Contact: Katie Lambeth    615-859-3937    klamberth@lodenvision.com   
Principal Investigator: James Loden, MD         
United States, Texas
Parkhurst NuVision Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Amy Ford    210-428-6788    nuvision.amy@gmail.com   
Principal Investigator: Gregory D Parkhurst, MD         
United States, Virginia
Liberty Laser Eye Center Not yet recruiting
Vienna, Virginia, United States, 22182
Contact: Travis A Johnson, Bachelor's    571-234-5678 ext 104    tjohnson@libertylasereye.com   
Principal Investigator: Nancy A Tanchel, MD         
Sponsors and Collaborators
Crowd Health Research, LTD
Investigators
Principal Investigator: Nancy A Tanchel, MD Liberty Laser Eye Center
  More Information

No publications provided

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:
Riboflavin
Vitamin B Complex
Vitamins
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014