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Innovative soft contact lens for treating corneal edema
Poster Details
First Author: C.Feinbaum SWEDEN
Co Author(s): O. Daphnah A. Marcovich
Abstract Details
Purpose:
It is a prospective, crossover, randomized study. Primary aim is assessing safety and effectiveness of the Hyper-CL&trade lens. Safety will be assessed by evaluating rate of adverse events occurring throughout study period. Effectiveness is assessed measuring changes in corneal thickness.
Setting:
Kaplan Medical Center, Rehovot Israel, Barzilai Medical Center, Ashkelon, Israel
Methods:
12 eyes with corneal edema was study population. No treatment occurred 7 days prior to first treatment. Then, each subject was treated, according to a set pattern regimen, 7 days with the Hyper-CL&trade lens (treatment A), 7 days with Hyper-CL&trade lens + salt solution (treatment B), and 7 days with salt solution only (treatment C). One week break without any treatment between treatments. Clinical evaluation was performed at 7, 14, 21, 28, 35 and 42 days post baseline. Only one subjects' eye will be treated. In case of bilateral corneal edema the physician identified the most suitable eye for treatment.
Results:
No adverse event occurred during the wearing the Hyper-CL&trade lens. None of the lens designs caused any side effects rather than normal irritation due to the existence of a contact lens on the cornea. The average baseline pachometry before treatment was 800µm, after washout with 5% NaCl 722µm, and after Hyper-CL&trade with 5% NaCl 688µm and again after wash out 666µm. The result is an average decrease of corneal thickness of 134µm. Discomfort was noted in 2 eyes and in one eye there was a tendency for the lens to drop out. A slight improvement of vision was noted.
Conclusions:
The study encompassed a total of 14 subjects. Safety and efficacy of the Hyper-CL&trade have been established. A larger multicenter study is necessary to make sure this method is effective for corneal edema and corneal dystrophies. The method could be an alternative to other more drastic treatments of corneal disease. FINANCIAL INTEREST: One of more of the authors... receives consulting fees, retainer, or contract payments from a competing company