June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Randomized Controlled Trial Comparing the Effects on Eye Pressure of Intravitreal Triamcinolone Injection versus Intravitreal Dexamethasone (Ozurdex) Implant in Patients with Diabetic Macular Edema TRIDEX TRIAL
Author Affiliations & Notes
  • Enzo Augusto Medeiros Fulco
    Ophthalmology, State University of Sao Paulo - USP, Natal, Rio Grande Do Norte, Brazil
  • Natacha Bíscaro Junqueira
    Ophthalmology, State University of Sao Paulo - USP, Natal, Rio Grande Do Norte, Brazil
  • Andre Messias
    Ophthalmology, State University of Sao Paulo - USP, Natal, Rio Grande Do Norte, Brazil
  • Rodrigo Jorge
    Ophthalmology, State University of Sao Paulo - USP, Natal, Rio Grande Do Norte, Brazil
  • Footnotes
    Commercial Relationships   Enzo Fulco, None; Natacha Junqueira, None; Andre Messias, None; Rodrigo Jorge, None
  • Footnotes
    Support  none
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 289. doi:
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      Enzo Augusto Medeiros Fulco, Natacha Bíscaro Junqueira, Andre Messias, Rodrigo Jorge; Randomized Controlled Trial Comparing the Effects on Eye Pressure of Intravitreal Triamcinolone Injection versus Intravitreal Dexamethasone (Ozurdex) Implant in Patients with Diabetic Macular Edema TRIDEX TRIAL. Invest. Ophthalmol. Vis. Sci. 2020;61(7):289.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The primary objective of this study is to compare effects on intraocular pressure (IOP) change and the need for eye drop hypotension and / or surgery on IOP reduction between the Dexamethasone Implant (Ozurdex) and triamcinolone groups. Secondary objectives are: To compare the effects to Optical Coherence Tomography during 12 weeks of intravitreal triamcinolone 4 mg injection or Ozurdex on macular thickening and intraretinal fluid in eyes with EMD.

Methods : A prospective study of 20 patients diagnosed with diabetic macular edema (EMD) without significant cataract will be randomized to the intravitreal triamcinolone 4 mg injection or use of Dexamethasone Implant (Ozurdex) group. Evaluations will include complete ophthalmologic assessment with best corrected visual acuity measurement, retinography and angiography, and OCT before treatment and at baseline, 4, 8, 12, 16, and 24 weeks after the procedure. The sample size was based on the standard deviation of intraocular pressure of our group study involving intravitreal triamcinolone injection for diabetic macular edema (Paccola et al.) Considering a power of 80%. A sample of 20 paired patients (40 paired eyes) will be sufficient to detect a difference of 1.5 mmHg in intraocular pressure between groups.

Results : Mean intraocular pressure at baseline and 4 weeks after the procedure for ozurdex are respectively: 15,78 and 16,22. Mean intraocular pressure at baseline and 4 weeks after the procedure for triancinolone injection are respectively: 15,71 and 18,33. Figure 1 Optical coherence tomography (OCT) at baseline and 4 weeks after the procedure for ozurdex are respectively: 478,83 and 365,16. OCT at baseline and 4 weeks after the procedure for triancinolone injection are respectively: 458,16 and 369,94. Figure 2.

Conclusions : Triancinolone may have a greater increase in intraocular pressure, despite simalar effect in central macular thickness. Wait for final follow up will allow us better evaluation.

This is a 2020 ARVO Annual Meeting abstract.

 

 

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