Progressive Keratoconus or Ectasia Treatment Plan

February 7, 2023 updated by: Stephen Trokel

Increasing CrossLinking of Corneal Collagen in Eyes With Progressive Keratoconus or Ectasia

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Potential candidates will undergo a complete eye examination to determine their eligibility for treatment. Eligible subjects will be prepared for treatment in accordance with the instructions for use in the UV-X™ Illumination System Operator's Manual, including the administration of the riboflavin and preoperative medications (e.g. topical anesthetics). Prescriptions for postoperative medications and written postoperative instructions will be given to each subject and reviewed prior to discharge. All subjects will have follow-up examination at 1 day, 1 week, 3 month and 6 month.

Study Type

Expanded Access

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Edward Harkness Eye Institute-Columbia University Medical Center

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 associated with 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: 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.

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?

Collaborators and Investigators

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

Sponsor

Stephen Trokel

Investigators

  • Principal Investigator: Stephen L Trokel, MD, Columbia University, Department of Ophthalmology, College of Physicians and Surgeons

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (ESTIMATE)

June 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAF0594

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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