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

Università degli Studi di Brescia

Status: Completed

Conditions: Hypertensive Patients With Retinal Vein Occlusion

Treatments: Device: Dexamethasone Intravitreal Implant (Ozuredex)

Study type: Interventional

Funder types: Other

Identifiers

NCT01789437

DIAMETER-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

30 participants in 1 patient group

Dexamethasone Intravitreal Implant

Active Comparator group

Treatment:

Device: Dexamethasone Intravitreal Implant (Ozuredex)