Hypertensive Patients With Retinal Vein Occlusion Clinical Trial
Official title:
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
| Verified date | February 2013 |
| Source | Università degli Studi di Brescia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | January 2013 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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). |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Italy | Spedali Civili di Brescia | Brescia | BS |
| Lead Sponsor | Collaborator |
|---|---|
| Università degli Studi di Brescia |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of outer arteriolar diameter | the primary endpoint was at 6 months | No | |
| Primary | change of inner arteriolar diameter | the primary endpoint was at 6 months | No | |
| Secondary | 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. | Yes |