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

NCT ID: NCT01789437

Last Updated: 2013-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

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.

Detailed Description

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Conditions

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Hypertensive Patients With Retinal Vein Occlusion

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dexamethasone Intravitreal Implant

Group Type ACTIVE_COMPARATOR

Dexamethasone Intravitreal Implant (Ozuredex)

Intervention Type DEVICE

Interventions

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Dexamethasone Intravitreal Implant (Ozuredex)

Intervention Type DEVICE

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Russo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Russo, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Brescia, Italy

Locations

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Spedali Civili di Brescia

Brescia, BS, Italy

Site Status

Countries

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Italy

Other Identifiers

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DIAMETER-001

Identifier Type: -

Identifier Source: org_study_id

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