Keratoconus and Ectasia Treatment Plan

Expanded access is currently available for this treatment.
Verified February 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Stephen Trokel, Columbia University
ClinicalTrials.gov Identifier:
NCT01384773
First received: June 27, 2011
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

Keratoconus and pellucid marginal degenerations are genetically based ocular conditions and post surgical ectasia is an iatrogenic condition. These diseases are characterized by weakening of the front part of the eye that causes thinning and distortion. This distortion results in unevenness of the cornea and produces progressive near-sightedness and irregularity, which causes loss of vision when using eyeglasses. When eyeglasses fail to give enough vision, the the investigators use rigid contact lenses to create an artificial front eye surface. This improves visual acuity in many patients although they eventually fail either because they cannot be tolerated or the surface irregularity has become so severe that they are rejected. At this stage there is usually thinning and loss of clarity of the eye.

There has been no treatment for this other than corneal transplantation, a complex surgical procedure with a significant complication rate and a delay in visual recovery. The treatment the investigators wish to perform strengthens the front of the eye by a chemical reaction using light and riboflavin. This technique has been studied over a decade and is widely used throughout the world. The FDA approved multicenter American clinical study is being analyzed in anticipation of its submission to the FDA for PreMarket approval. Because this is a progressive condition, the investigators wish to be able to offer this on a limited basis to patients in need with vision loss.

Any treatment that can delay or prevent corneal transplantation is of great benefit. The investigators believe the evidence is compelling that this treatment is the sole alternative to surgical transplantation.


Condition Intervention
Keratoconus
Ectasia
Other: Riboflavin Solution
Device: UV-X Illumination System

Study Type: Expanded Access     What is Expanded Access?
Official Title: Increasing CrossLinking of Corneal Collagen in Eyes With Progressive Keratoconus or Ectasia

Resource links provided by NLM:


Further study details as provided by Columbia University:

Study Start Date: September 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Riboflavin Solution
    This solution is used to saturate the corneal stroma prior to its photochemical activation by the IROC UV-X illuminator.
    Other Name: Medio-Cross Riboflavin 0.1% ophthalmic solution
    Device: UV-X Illumination System
    IROC UV-X irradiation system creates a uniform 11 mm circle of UVA light that is focused onto the corneal surface. This system is designed to irradiate the riboflavin saturated cornea with a uniform field of UVA light centered at 365 nm.
    Other Name: IROC UV-X System
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects who have one or both eyes that meet all of the following criteria will be considered candidates for this treatment:

For Keratoconus and Post Refractive Surgery Ectasia:

  1. 16 years of age or older
  2. Having a diagnosis of keratoconus with one or more of the following changes over a period of 24 months or less.

    1. An increase of >; 1.00 D in the steepest keratometry value (or sim K)
    2. An increase of >; 1.00 D in regular astigmatism evaluated by subjective manifest refraction
    3. A myopic shift (decrease in the spherical equivalent) of > 0.50 D on subjective manifest refraction
    4. Documented decrease in visual acuity
    5. Irregular astigmatism and topographic features of ectasia.
  3. Presence of central or inferior steepening on the Pentacam map.
  4. Axial topography consistent with keratoconus
  5. Slit lamp findings associated with keratoconus must be documented:

    • Fleischer ring
    • Vogt striae
    • Corneal thinning
    • Corneal scarring
  6. Contact Lens Wearers Only:

    a. Removal of contact lenses are required prior to the screening

  7. Signed written informed consent

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this treatment:

  1. No evidence of progression.
  2. Excessively thin corneas.
  3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:

    1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
    2. Clinically significant corneal scarring in the proposed treatment zone
  4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
  5. A known sensitivity to treatment medications
  6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384773

Contacts
Contact: MaEdylin Bautista, MD 212.305.5922 mmb2225@columbia.edu

Locations
United States, New York
Edward Harkness Eye Institute-Columbia University Medical Center
New York, New York, United States, 10032
Contact: MaEdylin Bautista, MD    212-305-5922    mmb2225@columbia.edu   
Principal Investigator: Stephen Trokel, MD         
Sub-Investigator: Leejee Suh, MD         
Sub-Investigator: George Florakis, MD         
Sponsors and Collaborators
Stephen Trokel
Investigators
Principal Investigator: Stephen L Trokel, MD Columbia University, Department of Ophthalmology, College of Physicians and Surgeons
  More Information

Publications:
Responsible Party: Stephen Trokel, Professor of Clinical Ophthalmology, Columbia University
ClinicalTrials.gov Identifier: NCT01384773     History of Changes
Other Study ID Numbers: AAAF0594
Study First Received: June 27, 2011
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Keratoconus
Ectasia
UVA light
riboflavin
post-LASIK (laser in situ keratomileusis)
pellucid marginal degeneration
irregular astigmatism

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Pathological Conditions, Anatomical
Corneal Diseases
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 15, 2014