title: Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema.
abstract: OBJECTIVE
  To test the safety and efficacy of topical 1.5% dexamethasone aqueous eye drops with cyclodextrin microparticles for diabetic macular edema (DME).
  
  
  METHODS
  Nineteen eyes of 19 consecutive patients with DME were administered dexamethasone-cyclodextrin eye drops three or six times a day for 4 weeks and then observed for 4 weeks without treatment. Visual acuity, intraocular pressure, and spectral domain optical coherent tomography-measured central macular thickness recordings at weeks 0 (baseline), 4, and 8. These parameters were compared using Bonferroni-corrected paired t-tests.
  
  
  RESULTS
  At weeks 0, 4, and 8, logMAR visual acuity (mean ± SD) was 0.52 ± 0.41, 0.37 ± 0.40 (P = 0.0025 vs. baseline), and 0.45 ± 0.41, respectively; central macular thickness (μm) was 512 ± 164, 399 ± 154 (P = 0.0016 vs. baseline), and 488 ± 172 (P = 0.0116 versus week 4), respectively; and intraocular pressure (mm Hg) was 15.2 ± 3.1, 17.4 ± 4.2 (P = 0.0015 vs. baseline) and 15.8 ± 4.0, respectively. At week 4, in 12 (63%) of 19 eyes, central macular thickness had decreased more than 10%, and the mean change was -20% (-65% to +10%). In 14 of 19 eyes (74%) visual acuity (logMAR) had improved more than 0.1 at week 4. No subjects showed severe adverse effects related to the eye drops.
  
  
  CONCLUSIONS
  Based on this short pilot study, topical dexamethasone-cyclodextrin eye drops are well tolerated, decrease central macular thickness, and improve visual acuity in DME. The results encourage comparative studies between dexamethasone cyclodextrin microparticle eye drops and other treatments for DME. (http://www.umin.ac.jp/ctr number, UMIN000001790.).
authors: Department of Ophthalmology, Shimane University Faculty of Medicine, Enya 89-1, Izumo, Shimane 693-8501, Japan. tanito-oph@umin.ac.jp
authors: Masaki
authors: M
authors: Tanito
authors: Katsunori
authors: K
authors: Hara
authors: Yasuyuki
authors: Y
authors: Takai
authors: Yotaro
authors: Y
authors: Matsuoka
authors: Nobuhiro
authors: N
authors: Nishimura
authors: Phatsawee
authors: P
authors: Jansook
authors: Thorsteinn
authors: T
authors: Loftsson
authors: Einar
authors: E
authors: Stefánsson
authors: Akihiro
authors: A
authors: Ohira
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D047392:beta-Cyclodextrins / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D047392:beta-Cyclodextrins; C100693:dexamethasone-beta-cyclodextrin; D003907:Dexamethasone