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

Not Applicable

Completed

• Conditions: Hypertensive Patients With Retinal Vein Occlusion
• Interventions: Device: Dexamethasone Intravitreal Implant (Ozuredex)

• Registration Number: NCT01789437
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-08
• Last Update Submitted: 2013-02-08
• Study First Posted: 2013-02-12
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Intravitreal Implant	Dexamethasone Intravitreal Implant (Ozuredex)	-

Primary Outcome Measures

Name	Time	Method
change of outer arteriolar diameter	the primary endpoint was at 6 months
change of inner arteriolar diameter	the primary endpoint was at 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Spedali Civili di Brescia; 🇮🇹 Brescia, BS, Italy