CClinicalTrials.gg
Status unknownNCT02095730Updated Mar 26, 2014

Corneal Cross-Linking Comparing Variables

A Phase 3 interventional study of Epithelium-On Riboflavin and Epithelium-Off Riboflavin in Unstable Corneas, sponsored by Crowd Health Research, LTD. Status unknown at 16 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Crowd Health Research, LTD · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Unstable Corneas

Browse trials for

Keywords

  • crosslinking
  • cornea
  • keratoconus
  • ectasia
  • irradiance
  • riboflavin
03

In context

Corneal Diseases

130 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.

This study's planned enrollment of 500 is above the median of 32 across 78 interventional studies indexed under Corneal Diseases.

Browse Corneal Diseases studies →

Lead sponsor

This is the only study on the registry with Crowd Health Research, LTD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    Epi-On Continuous

    Continuous beam of UV light treating cornea with surface epithelium present

    Drug: Epithelium-On Riboflavin · Device: UV Light - Continuous Beam

  • Active comparator
    Epi-Off Continuous

    Continuous beam of UV light treating cornea without surface epithelium present

    Drug: Epithelium-Off Riboflavin · Device: UV Light - Continuous Beam

  • Active comparator
    Epi-On Pulsed

    Pulsed beam of UV light treating cornea with surface epithelium present

    Drug: Epithelium-On Riboflavin · Device: UV Pulsed Beam

  • Active comparator
    Epi-Off Pulsed

    Pulsed beam of UV light treating cornea without surface epithelium present

    Drug: Epithelium-Off Riboflavin · Device: UV Pulsed Beam

Interventions

  • DrugEpithelium-On Riboflavin

    Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative

    Also known as: Vitamin B2

  • DrugEpithelium-Off Riboflavin

    Riboflavin 0.1% Phosphate Sodium solution

    Also known as: Vitamin B2

  • DeviceUV Light - Continuous Beam

    5 minutes of constant UV exposure to saturated cornea

    Also known as: Peschke Vario CCL-365 UV system

  • DeviceUV 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

    Also known as: Peschke Vario CCL-365 UV system

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    Uncorrected visual acuity

    Time frame: 2 years

07

Study locations

16 sites
  • LaserVue Eye
    Santa Rosa, California 95403, United States
    • Jay Bansal, MD · Contact · bansal@laservue.com · 707-522-6200
    • Jay Bansal, MD · Principal investigator
  • Icon Lasik
    Denver, Colorado 80210, United States
    • Richard Anderson, OD · Contact · ra@icondenver.com · 720-524-1001
    • Douglas Campbell, DO · Principal investigator
  • Gulani Vision Institute
    Jacksonville, Florida 32216, United States
  • Eye Consultants of Atlanta
    Atlanta, Georgia 30339, United States
  • Midwest Center for Sight
    Des Plaines, Illinois 60016, United States
    • James Katz, MD · Contact · jamesakatz@aol.com · 847-824-3127
    • James Katz, MD · Principal investigator
  • Bond Eye Associates
    Pekin, Illinois 61554, United States
    • William Bond, MD · Contact · pekineye@yahoo.com · 309-353-6660
    • William Bond, MD · Principal investigator
  • Discover Vision Center
    Leawood, Kansas 66211, United States
  • Southern Eye Center
    Hattiesburg, Mississippi 39402, United States
    • Cameron Griffith, MD · Contact · csgriff1@earthlink.net · 318-464-0306
    • Cameron Griffith, MD · Principal investigator
  • Mercy Clinic Eye Specialists
    Springfield, Missouri 65807, United States
  • LASIK of Nevada
    Las Vegas, Nevada 89123, United States
    • Valerie Serett · Contact · vserette@yahoo.com · 702-636-2010
    • Richard Rothman, MD · Principal investigator
    • Rajy Rouweyha, MD · Sub investigator
  • James Lewis MD PC
    Elkins Park, Pennsylvania 19027, United States
  • Memorial Eye Institute
    Harrisburg, Pennsylvania 17112, United States
    • Sherrie Reed · Contact · crosslinkstudy@memorialeye.com · 717-657-2020
    • Bennett Chotiner, MD · Principal investigator
    • Erik Chotiner, MD · Principal investigator
  • Carolina Eye Care
    Mt. Pleasant, South Carolina 29464, United States
  • Loden Vision Centers
    Goodlettsville, Tennessee 37072, United States
  • Parkhurst NuVision
    San Antonio, Texas 78229, United States
    • Amy Ford · Contact · nuvision.amy@gmail.com · 210-428-6788
    • Gregory D Parkhurst, MD · Principal investigator
  • Liberty Laser Eye Center
    Vienna, Virginia 22182, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02095730
Lead sponsor
Crowd Health Research, LTD
Responsible party
Sponsor
First posted
Mar 26, 2014
Start date
May 2014
Primary completion
May 2016 (estimated)
Last update
Mar 26, 2014

Study contacts

Travis A Johnson, Bachelor's
Contact
tjohnson@libertylasereye.com
571-234-5678 ext. 104
Nancy A Tanchel, MD
Contact
ntanchel@libertylasereye.com
571-234-5678 ext. 103
Nancy A Tanchel, MD
principal investigator · Liberty Laser Eye Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion