Progressive Keratoconus or Ectasia Treatment Plan

Status No longer available

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01384773
Study type	Expanded Access
Source	Columbia University
Contact
Status	No longer available
Phase

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.