title: Steroid eye drop treatment (difluprednate ophthalmic emulsion) is effective in reducing refractory diabetic macular edema.
abstract: OBJECTIVE
  To evaluate the efficacy of treatment of refractory diabetic macular edema (DME) after vitrectomy with difluprednate ophthalmic emulsion 0.05% (Durezol(TM)), and to compare this treatment with sub-Tenon's injection of triamcinolone (STTA).
  
  
  METHODS
  This study enrolled patients with refractory diabetic macular edema that persisted despite pars plana vitrectomy in our clinic. In all subjects, more than 3 months had passed since prior treatment. Eleven eyes in ten subjects were treated with STTA (STTA group), and 11 eyes in seven subjects were treated with difluprednate ophthalmic emulsion 0.05% (Durezol(TM), Sirion Therapeutics Inc., USA) 4 times daily for the first month and then twice daily for 2 months (eye drop group).
  
  
  RESULTS
  In the eye drop group, mean VA (+/- SD) was 0.67 +/- 0.35 logMAR and mean retinal thickness was 500.6 +/- 207.7 mum at baseline. After 3 months of treatment, mean VA was 0.67 +/- 0.29 and mean retinal thickness had decreased to 341.2 +/- 194.8 mum. The mean minimum value of RT during the treatment period was 300.6 +/- 123.2 mum, and significantly lower than that at baseline (Mann-Whitney U test: P = 0.003). In the STTA group, mean VA (+/- SD) was 0.67 +/- 0.35 logMAR, and mean retinal thickness was 543.3 +/- 132.6 mum at baseline. After 3 months of treatment, mean VA was 0.49 +/- 0.67, and mean retinal thickness had decreased to 378.6 +/- 135 mum. The mean minimum value of RT during the treatment period was 349.9 +/- 113.8 mum, and significantly lower than at baseline (Mann-Whitney U test: P = 0.003). The rate of effective improvement in RT did not differ between the eye drop group (73%) and STTA group (84%) (Fisher's exact test: P = 1).
  
  
  CONCLUSIONS
  Comparable improvements of retinal thickness were observed in the STTA and eye drop groups. Instillation of difluprednate ophthalmic emulsion 0.05% is a safe and effective treatment that does not require surgical intervention and does not produce severe side-effects.
authors.affiliation: Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine, 2-2-2, Iidanishi, Yamagata, Yamagata, 9909585, Japan. nakano-ygt@umin.ac.jp
authors.forename: Sakiko
authors.initials: S
authors.lastname: Nakano
authors.forename: Teiko
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Eriko
authors.initials: E
authors.lastname: Kirii
authors.forename: Sachi
authors.initials: S
authors.lastname: Abe
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Yamashita
mesh_terms: D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000601:surgery; D004655:Emulsions; D005260:Female; D005477:Fluprednisolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007267:Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000009:adverse effects / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000627:therapeutic use; D014792:Visual Acuity / Q000502:physiology; D014821:Vitrectomy
chemical_list: D004655:Emulsions; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D005477:Fluprednisolone; D014222:Triamcinolone Acetonide; C015808:difluprednate