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Atsuko Fujii, Winston Chamberlain, Mitsuyoshi Azuma, Thomas R Shearer; Selecting Fuchs Patients for Drug Trials Involving Endothelial Cell Migration. Invest. Ophthalmol. Vis. Sci. 2014;55(13):996.
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Patients with Fuchs endothelial dystrophy (FED) comprise a large pool of patients seeking corneal endothelial keratoplasties (EK). Pathological features of FED include corneal opacity and edema, decreased endothelial cell density, and endothelial cell polymegathism and pleomorphism. Since FED is usually late onset, patients may exhibit other geriatric eye conditions such as glaucoma and cataracts. Recent studies indicate that drug treatment has the potential for improving migration of endothelial cells in FED. Hence, FED might be managed by drug treatment before becoming severe enough to require EK. For a clinical trial of such a drug, we hypothesize that selecting an adequate number of FED with only moderately compromised cell densities will be challenging. Thus, the purpose of the present study was to determine the frequency and base line values of FED patients with moderately decreased cell densities.
A retrospective data mining study was performed on patient charts presenting at a large US NW academic health center by searching for diagnosis ICD9 code 371.57 and Fuchs corneal dystrophies, including those with prior cataract surgeries and/or existing glaucoma. Prior corneal transplants were excluded. Non-contact specular photomicroscopic data (Topcon-2000) were obtained from the central region whenever possible, and individual eyes were grouped according to cell density (cells/mm2): Severe (<800), Moderate (800-1500), and Mild (>1500).
The values for 66 eyes from the FED patients were (mean ± SD): thickness 0.563 ± 0.058 mm, area 575 ± 310 μm2/cell, CV 22 ± 6, and density 1989 ± 700 cells/mm2. The Moderate subgroup with cell density values of 1228 ± 191 (14) comprised 21% of the total FED patient pool. Corneal thickness did not correlate with cell density in the overall FED pool or within the Moderate subgroup (Pearson correlation test, r2 ≦ 0.01).
In an initial screening of a population, we found approximately 1/5 of the patients fell into the Moderate subgroup. When testing for enhanced endothelial cell migration by topical drugs, clinical trials will need to initially screen a large number of FED patients to obtain an adequate number of those with moderately compromised cell densities. Drs. Shearer and Chamberlain receive a research contract and/or consulting fees from, and Dr. Azuma and Ms. Fujii are employees of, Senju Pharmaceutical Co., Ltd.
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