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Masaki Tanito, Katsunori Hara, Yasuyuki Takai, Yotaro Matsuoka, Akihiro Ohira, Thorsteinn Loftsson, Einar Stefánsson; Topical Dexamethasone-Cyclodextrin Nanoparticle Eye Drops For Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2011;52(14):585.
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To test the efficacy of topical 1.5% dexamethasone aqueous eye drops prepared by cyclodextrin nanoparticle technology (Dex-Cx) for diabetic macular edema (DME).
In this pilot study, 16 eyes of 16 patients with chronic DME (9 males and 7 females; mean age 63 years) were consecutively recruited at the Shimane University Hospital. Patients received Dex-Cx eye drops 3 times or 6 times a day for 4 weeks. Visual acuity (VA), intraocular pressure (IOP), and central macular thickness measured by spectral domain optical coherent tomography were recorded at weeks 0 (baseline), 4, and 8. These parameters were compared among 3 time points by using Bonferroni-corrected paired t-tests. Percent change of central macular thickness from baseline to week 4 (%thickness change) was compared between groups separated by several parameters by un-paired t-test.
At weeks 0, 4, and 8, LogMAR VA (mean+/-SD) was 0.52+/-0.40, 0.37+/-0.38 (p=0.0086 vs baseline), and 0.44+/-0.40, respectively; central macular thickness (µm) was 512+/-173, 389+/-153 (p=0.0036 vs baseline), and 482+/-188 (p=0.0166 vs week 4), respectively; and IOP (mmHg) was 15.1+/-3.4, 17.3+/-4.6 (p=0.0051 vs baseline), and 15.5+/-4.2, respectively. At week 4, 11 of 16 eyes decreased central macular thickness more than 10 %, and 10 of 16 eyes improved LogMAR VA more than 0.1. Mean %thickness change was -21.4% (-65% to +9.8%). There was significant difference in %thickness change between vitrectomized (-54%) and un-vitrectomized (-17%) eyes (p=0.0138), while other parameters including age (-25% and -16% for ≤65y and >65y, respectively), sex (-17% and -27% for male and female, respectively), duration of disease (-23% and -20% for ≤6M and >6M, respectively), and lens status (-17% and -36% for phakia or pseudophakia, respectively), regimen of treatment (-15% and -35% for 3 times and 6 times/day, respectively) did not reach statistical significance. No subjects showed severe side effects related to topical Dex-Cx.
Topical Dex-Cx eye drops decrease central macular thickness in DME and improves visual acuity. The efficacy of the eye drops is enhanced in vitrectomized eyes.
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