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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertensive Patients With Retinal Vein Occlusion

Intervention / Treatment
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* Device: Dexamethasone Intravitreal Implant (Ozuredex)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone Intravitreal Implant<br> | Device: Dexamethasone Intravitreal Implant (Ozuredex)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal vein occlusion, systemic hypertension, arteriolar diameter