Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.

Overview

to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients with retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg (DEX) compared to a matched control group of normal eyes in non-hypertensive subjects.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2012

Interventions

  • Device: Dexamethasone Intravitreal Implant (Ozuredex)

Arms, Groups and Cohorts

  • Active Comparator: Dexamethasone Intravitreal Implant

Clinical Trial Outcome Measures

Primary Measures

  • change of outer arteriolar diameter
    • Time Frame: the primary endpoint was at 6 months
  • change of inner arteriolar diameter
    • Time Frame: the primary endpoint was at 6 months

Secondary Measures

  • Secondary outcome measures were as follows: adverse ocular events; mean change in visual acuity; and mean change in central macular thickness.
    • Time Frame: Outcomes were analyzed at 4 intermediate time points: 30, 60, 90, and 150 days.

Participating in This Clinical Trial

Inclusion Criteria

  • ability to provide written informed consent and comply with study assessments for the full duration of the study; – age > 20 years; – decreased visual acuity as a result of clinically detectable ME associated with either CRVO or BRVO; – the duration of macular edema was required to be between 4 and 24 weeks for both CRVO and BRVO; – retinal thickness in the central subfield (as measured using optical coherence tomography) had to be > 350 µm in the study eye. Exclusion Criteria:

  • the exclusion criteria were as follows: diabetes; previous intravitreal anti-VEGF therapy or intravitreal steroid therapy; previous photodynamic therapy or focal laser; active retinal or optic disc neovascularization; active or history of choroidal neovascularization; presence of rubeosis iridis; any active infection; glaucoma, current ocular hypertension, or a history of steroid-induced intraocular pressure (IOP) increase in either eye; or concurrent eye disease in the study eye that could compromise visual acuity (e.g., choroidal neovascularization, diabetic retinopathy, epiretinal membrane).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Università degli Studi di Brescia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrea Russo, Dr. – Università degli Studi di Brescia
  • Overall Official(s)
    • Andrea Russo, Dr., Principal Investigator, University of Brescia, Italy

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