UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia

This study is currently recruiting participants.
Verified March 2011 by Mercy Center for Corrective Eye Surgery
Sponsor:
Information provided by:
Mercy Center for Corrective Eye Surgery
ClinicalTrials.gov Identifier:
NCT01325298
First received: March 28, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

The primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery ectasia.


Condition Intervention Phase
Keratoconus
Ectasia
Corneal Ectasia
Device: UV-X Light
Drug: Riboflavin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia

Resource links provided by NLM:


Further study details as provided by Mercy Center for Corrective Eye Surgery:

Primary Outcome Measures:
  • Change in corneal curvature [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by maximum keratometry (Kmax)


Secondary Outcome Measures:
  • corrected distance acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    best spectacle corrected distance acuity

  • corneal endothelial cell count [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • pachymetry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Minimal corneal thickness


Estimated Enrollment: 250
Study Start Date: March 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20 Minute UV-X Light Treatment Duration

20 Minute UV-X Light Treatment Duration

Note: "UV-X" is the trademark of Peschke GmbH

Device: UV-X Light
UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
Drug: Riboflavin
Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.
Active Comparator: 30 Minute UV-X Light Treatment Duration
30 Minute UV-X Light Treatment Duration
Device: UV-X Light
UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
Drug: Riboflavin
Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.

  Eligibility

Ages Eligible for Study:   14 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

i. Age 14 years or older for keratoconus subjects since disease often begins at puberty, and 18 years or older for post-refractive surgery keratectasia and post-transplant patients

ii. Signed, dated, written informed consent

iii. Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 24 months or less before randomization:

  • An increase of at least 1.0 diopter in the steepest keratometry value (or sim K), or
  • an increase of at least 1.0 diopter in regular astigmatism evaluated by subjective manifest refraction, or
  • a myopic shift (decrease in the spherical equivalent) of at least 0.5 diopters on subjective refraction, or
  • documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia

iv. Have minimal preoperative corneal thickness of 375 microns or more, as measured in the office with epithelium not yet removed

v. For subjects with non-post refractive surgery keratoconus diagnosis only:

  • 14 years or older to 55 years of age,
  • axial topography consistent with keratoconus such as presence of abnormal central or paracentral steepening on the corneal topography map, or presence of one or more slit lamp findings associated with keratoconus, such as

    • Fleischer ring
    • Vogt striae
    • Corneal thinning
    • Corneal scarring

vi. For contact lens wearers only:

Removal of contact lenses for the required period of time prior to final screening refraction:

  • Contact lens minimum discontinuation time two weeks for soft, extended wear, soft toric, and rigid gas permeable lenses

vii. For patients with post-refractive surgery keratectasia:

  • History of excimer laser refractive surgery with increasing refractive astigmatism and corneal topographic or keratometric astigmatism of 0.5 or more, or a history of decreasing best spectacle corrected visual acuity associated with the presence of topography suggestive of keratoconus or pellucid marginal degeneration or abnormal higher order aberrations (especially coma) on the aberration mapping of the eye.

viii. For patients with corneal transplants:

  • History of corneal transplant for keratoconus with documented increasing refractive astigmatism and corresponding topographic irregularity occurring at least one year after corneal transplantation, not attributable to transplant suture removal and occurring during the most recent two years.

Exclusion Criteria:

i. Patients with excessively thin corneas. (Intraoperative minimal corneal thickness in the swollen state with the epithelium removed must exceed 400 microns)

ii. Keratometric readings greater than 62D

iii. No evidence of keratoconus/keratectasia progression over the prior three years

iv. Age less than 55 years but under

  • 14 years for keratoconus patients
  • 18 years for post-refractive surgery keratectasia and post-transplant patients

    v. Previous ocular condition in the eye(s) to be treated that might, in the investigator's opinion, predispose to complications (such as history herpes simplex keratitis, corneal melt, perforated corneal ulcer, descemetocele, prior corneal damage from chemical injury, herpes zoster keratitis, nystagmus, corneal scarring that significantly impairs vision, pre-existing glaucoma, glaucoma suspect, Goldmann applanation pressure exceeding 23 mm Hg, cataract, history of uveitis, active ocular disease that might lead to infection, corneal endothelial cell count below 1800 cells per square millimeter)

vi. Patients with a systemic condition that, in the investigator's opinion, might predispose to complications (such as Down syndrome, autoimmune disease, pregnancy or nursing at the time of initial treatment, history of alcohol abuse, being immunocompromised, allergy to riboflavin or other study medications)

vii. Patients who are unwilling or unable to comply with the study regimen and doctor's advice

viii. Patients unwilling to discontinue wear of rigid contact lenses in the eye to be operated on for at least one month before baseline examination, and for the first six months post−operatively

ix. Patient unwilling to discontinue contact lenses prior to baseline exam: one week for soft lenses, two weeks for rigid or soft toric lenses

x. Pregnancy at the time of proposed crosslinking

xi. Known hypersensitivity to riboflavin

xii. Central corneal endothelial cell count below 1400 cells per square millimeter.

xiii. Presence of significant central corneal stromal scar

xiv. History of delayed wound healing

xv. Immunocompromised patient

xvi. History of connective tissue disease (such as systemic lupus erythematosus, rheumatoid arthritis)

xvii. History of glaucoma, a Goldmann applanation pressure measured in keratoconus evaluation of above 24, or glaucoma suspect, xviii. Significant existing cataract

xix. Macular degeneration or confluent drusen of Bruchs membrane

xx. Evidence of past or present herpes simplex of the cornea

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325298

Contacts
Contact: Charisse Haas 815-363-2020 chaas@mhsjvl.org
Contact: Mark A Gurgos, COT 815-363-2020 mgurgos@mhsjvl.org

Locations
United States, Illinois
Mercy Center for Corrective Eye Surgery Recruiting
McHenry, Illinois, United States, 60050
Contact: Mark Gurgos, COT    815-363-2020    mgurgos@mhsjvl.org   
Contact: Robert L Epstein, MD    815-363-2020    rlepstein@aol.com   
Principal Investigator: Robert L Epstein, MD         
Sponsors and Collaborators
Mercy Center for Corrective Eye Surgery
Investigators
Principal Investigator: Robert L Epstein, MD Mercy Center for Corrective Eye Surgery
  More Information

Additional Information:
Publications:
Responsible Party: Robert L. Epstein, MD, Mercy Center for Corrective Eye Surgery
ClinicalTrials.gov Identifier: NCT01325298     History of Changes
Other Study ID Numbers: IND 109752
Study First Received: March 28, 2011
Last Updated: March 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mercy Center for Corrective Eye Surgery:
Keratoconus
Ectasia
cross linking
collagen cross linking
corneal crosslinking
corneal diseases
eye diseases

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Corneal Diseases
Pathological Conditions, Anatomical
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014