A Phase 2/3 interventional study of Riboflavin in Keratoconus and Ectasia, sponsored by Yaron S. Rabinowitz M.D.. Status unknown at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Yaron S. Rabinowitz M.D. · Phase 2/3, Interventional, and Treatment
This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.
In this study we will attempt to determine whether Collagen Cross Linking alone, one combined with insertion of INTACS is the most effective treatment for patients with progressive keratoconus in patients who have progressive disease.
These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 600 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →This is the only study on the registry with Yaron S. Rabinowitz M.D. as lead sponsor.
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Exclusion Criteria:
Corneal collagen cross-linking with riboflavin and UVA light
Drug: Riboflavin
Corneal collagen cross-linking with riboflavin and UVA light plus INTACS
Drug: Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Also known as: Peschke Meditrade
Effectiveness of UV-X cross linking to halt progression of keratoconus
Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry
Time frame: 10 years
Plan to share: No
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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