search
Back to results

Corneal Cross-Linking Comparing Variables

Primary Purpose

Unstable Corneas

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Epithelium-On Riboflavin
Epithelium-Off Riboflavin
UV Light - Continuous Beam
UV Pulsed Beam
Sponsored by
Crowd Health Research, LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Corneas focused on measuring crosslinking, cornea, keratoconus, ectasia, irradiance, riboflavin

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LaserVue Eye
  • Icon Lasik
  • Gulani Vision Institute
  • Eye Consultants of Atlanta
  • Midwest Center for Sight
  • Bond Eye Associates
  • Discover Vision Center
  • Southern Eye Center
  • Mercy Clinic Eye Specialists
  • LASIK of Nevada
  • James Lewis MD PC
  • Memorial Eye Institute
  • Carolina Eye Care
  • Loden Vision Centers
  • Parkhurst NuVision
  • Liberty Laser Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Epi-On Continuous

Epi-Off Continuous

Epi-On Pulsed

Epi-Off Pulsed

Arm Description

Continuous beam of UV light treating cornea with surface epithelium present

Continuous beam of UV light treating cornea without surface epithelium present

Pulsed beam of UV light treating cornea with surface epithelium present

Pulsed beam of UV light treating cornea without surface epithelium present

Outcomes

Primary Outcome Measures

Visual Acuity
Uncorrected visual acuity

Secondary Outcome Measures

Full Information

First Posted
March 20, 2014
Last Updated
March 21, 2014
Sponsor
Crowd Health Research, LTD
search

1. Study Identification

Unique Protocol Identification Number
NCT02095730
Brief Title
Corneal Cross-Linking Comparing Variables
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crowd Health Research, LTD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Corneas
Keywords
crosslinking, cornea, keratoconus, ectasia, irradiance, riboflavin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epi-On Continuous
Arm Type
Active Comparator
Arm Description
Continuous beam of UV light treating cornea with surface epithelium present
Arm Title
Epi-Off Continuous
Arm Type
Active Comparator
Arm Description
Continuous beam of UV light treating cornea without surface epithelium present
Arm Title
Epi-On Pulsed
Arm Type
Active Comparator
Arm Description
Pulsed beam of UV light treating cornea with surface epithelium present
Arm Title
Epi-Off Pulsed
Arm Type
Active Comparator
Arm Description
Pulsed beam of UV light treating cornea without surface epithelium present
Intervention Type
Drug
Intervention Name(s)
Epithelium-On Riboflavin
Other Intervention Name(s)
Vitamin B2
Intervention Description
Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
Intervention Type
Drug
Intervention Name(s)
Epithelium-Off Riboflavin
Other Intervention Name(s)
Vitamin B2
Intervention Description
Riboflavin 0.1% Phosphate Sodium solution
Intervention Type
Device
Intervention Name(s)
UV Light - Continuous Beam
Other Intervention Name(s)
Peschke Vario CCL-365 UV system
Intervention Description
5 minutes of constant UV exposure to saturated cornea
Intervention Type
Device
Intervention Name(s)
UV Pulsed Beam
Other Intervention Name(s)
Peschke Vario CCL-365 UV system
Intervention Description
5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Uncorrected visual acuity
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Keratoconus: 12 years of age or older Having a clinical diagnosis of progressive keratoconus consistent with: 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 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: Steepening by topography 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 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. These patients would have the choice of ring explant before Cross-Linking. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Travis A Johnson, Bachelor's
Phone
571-234-5678
Ext
104
Email
tjohnson@libertylasereye.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy A Tanchel, MD
Phone
571-234-5678
Ext
103
Email
ntanchel@libertylasereye.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Tanchel, MD
Organizational Affiliation
Liberty Laser Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LaserVue Eye
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Bansal, MD
Phone
707-522-6200
Email
bansal@laservue.com
First Name & Middle Initial & Last Name & Degree
Jay Bansal, MD
Facility Name
Icon Lasik
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Anderson, OD
Phone
720-524-1001
Email
ra@icondenver.com
First Name & Middle Initial & Last Name & Degree
Douglas Campbell, DO
Facility Name
Gulani Vision Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Gulani, MD
Phone
904-296-7393
Email
gulanivision@gulani.com
First Name & Middle Initial & Last Name & Degree
Arun Gulani, MD
Facility Name
Eye Consultants of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Long
Phone
404-351-2220
Email
teresa_long@eyeconsultants.net
First Name & Middle Initial & Last Name & Degree
W. Barry Lee, MD
Facility Name
Midwest Center for Sight
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Katz, MD
Phone
847-824-3127
Email
jamesakatz@aol.com
First Name & Middle Initial & Last Name & Degree
James Katz, MD
Facility Name
Bond Eye Associates
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Bond, MD
Phone
309-353-6660
Email
pekineye@yahoo.com
First Name & Middle Initial & Last Name & Degree
William Bond, MD
Facility Name
Discover Vision Center
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misty Robe, Associate's
Phone
816-478-1230
Email
mrobe@discovervision.com
First Name & Middle Initial & Last Name & Degree
John Doane, MD
Facility Name
Southern Eye Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Griffith, MD
Phone
318-464-0306
Email
csgriff1@earthlink.net
First Name & Middle Initial & Last Name & Degree
Cameron Griffith, MD
Facility Name
Mercy Clinic Eye Specialists
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Sekscinski
Phone
417-820-9393
Email
stephanie.sekscinski@mercy.net
First Name & Middle Initial & Last Name & Degree
Shachar Tauber, MD
Facility Name
LASIK of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Serett
Phone
702-636-2010
Email
vserette@yahoo.com
First Name & Middle Initial & Last Name & Degree
Richard Rothman, MD
First Name & Middle Initial & Last Name & Degree
Rajy Rouweyha, MD
Facility Name
James Lewis MD PC
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Lewis, MD
Phone
215-886-9090
Email
jslewis@jameslewis.com
First Name & Middle Initial & Last Name & Degree
James Lewis, MD
Facility Name
Memorial Eye Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17112
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherrie Reed
Phone
717-657-2020
Email
crosslinkstudy@memorialeye.com
First Name & Middle Initial & Last Name & Degree
Bennett Chotiner, MD
First Name & Middle Initial & Last Name & Degree
Erik Chotiner, MD
Facility Name
Carolina Eye Care
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helga Sandoval, MD
Phone
843-881-3937
Email
helga.sandoval@carolinaeyecare.com
First Name & Middle Initial & Last Name & Degree
Kerry Solomon, MD
First Name & Middle Initial & Last Name & Degree
Charlene Grice, MD
Facility Name
Loden Vision Centers
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Lambeth
Phone
615-859-3937
Email
klamberth@lodenvision.com
First Name & Middle Initial & Last Name & Degree
James Loden, MD
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Ford
Phone
210-428-6788
Email
nuvision.amy@gmail.com
First Name & Middle Initial & Last Name & Degree
Gregory D Parkhurst, MD
Facility Name
Liberty Laser Eye Center
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Travis A Johnson, Bachelor's
Phone
571-234-5678
Ext
104
Email
tjohnson@libertylasereye.com
First Name & Middle Initial & Last Name & Degree
Nancy A Tanchel, MD

12. IPD Sharing Statement

Learn more about this trial

Corneal Cross-Linking Comparing Variables

We'll reach out to this number within 24 hrs