Corneal Cross-Linking Comparing Variables

March 21, 2014 updated by: Crowd Health Research, LTD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Santa Rosa, California, United States, 95403
        • LaserVue Eye
        • Contact:
        • Principal Investigator:
          • Jay Bansal, MD
    • Colorado
      • Denver, Colorado, United States, 80210
        • Icon Lasik
        • Contact:
        • Principal Investigator:
          • Douglas Campbell, DO
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Gulani Vision Institute
        • Contact:
        • Principal Investigator:
          • Arun Gulani, MD
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Eye Consultants of Atlanta
        • Contact:
        • Principal Investigator:
          • W. Barry Lee, MD
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Midwest Center for Sight
        • Contact:
        • Principal Investigator:
          • James Katz, MD
      • Pekin, Illinois, United States, 61554
        • Bond Eye Associates
        • Contact:
        • Principal Investigator:
          • William Bond, MD
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Discover Vision Center
        • Contact:
        • Principal Investigator:
          • John Doane, MD
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39402
        • Southern Eye Center
        • Contact:
        • Principal Investigator:
          • Cameron Griffith, MD
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Mercy Clinic Eye Specialists
        • Principal Investigator:
          • Shachar Tauber, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • LASIK of Nevada
        • Contact:
        • Principal Investigator:
          • Richard Rothman, MD
        • Sub-Investigator:
          • Rajy Rouweyha, MD
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • James Lewis MD PC
        • Contact:
        • Principal Investigator:
          • James Lewis, MD
      • Harrisburg, Pennsylvania, United States, 17112
        • Memorial Eye Institute
        • Contact:
        • Principal Investigator:
          • Bennett Chotiner, MD
        • Principal Investigator:
          • Erik Chotiner, MD
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Carolina Eye Care
        • Contact:
        • Principal Investigator:
          • Kerry Solomon, MD
        • Sub-Investigator:
          • Charlene Grice, MD
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Loden Vision Centers
        • Contact:
        • Principal Investigator:
          • James Loden, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Parkhurst NuVision
        • Contact:
        • Principal Investigator:
          • Gregory D Parkhurst, MD
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Liberty Laser Eye Center
        • Contact:
        • Principal Investigator:
          • Nancy A Tanchel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Vitamin B2
Device: UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
Other Names:
  • Peschke Vario CCL-365 UV system
Active Comparator: Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
Device: UV Light - Continuous Beam
5 minutes of constant UV exposure to saturated cornea
Other Names:
  • Peschke Vario CCL-365 UV system
Drug: Epithelium-Off Riboflavin
Riboflavin 0.1% Phosphate Sodium solution
Other Names:
  • Vitamin B2
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Peschke Vario CCL-365 UV system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 2 years
Uncorrected visual acuity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crowd Health Research, LTD

Investigators

  • Principal Investigator: Nancy A Tanchel, MD, Liberty Laser Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-CHR 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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