Progressive Keratoconus or Ectasia Treatment Plan
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|ClinicalTrials.gov Identifier: NCT01384773|
Expanded Access Status : No longer available
First Posted : June 29, 2011
Last Update Posted : September 29, 2017
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 or disease||Intervention/treatment|
|Keratoconus Ectasia||Other: Riboflavin Solution Device: UV-X Illumination System|
|Study Type :||Expanded Access|
|Official Title:||Increasing CrossLinking of Corneal Collagen in Eyes With Progressive Keratoconus or Ectasia|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384773
|United States, New York|
|Edward Harkness Eye Institute-Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Stephen L Trokel, MD||Columbia University, Department of Ophthalmology, College of Physicians and Surgeons|