Retinal Thrombosis and Atherosclerosis

NCT02257333 | Unknown

• 1 other identifier: HEART VISION
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The retinal vein occlusion (RVO) is the second most common retinal disease after diabetic retinopathy, and is a common cause of unilateral visual loss. The risk factors that predispose to RVO are many and are generally the same as those found in vascular alterations involving other parts of the body, as in the case of stroke or coronary heart disease. Several authors have attempted to determine whether the pathogenesis of RVO can be of arterial type, considering the disease as consequent to atherosclerosis, rather than resulting from venous disease. Although less frequent than the other diseases RVO affects considerably on health care costs. Direct medical costs showed that in one year a patient with this disease has a higher than average cost for a patient with hypertension or glaucoma. Knowing the prevalence of the disease in Italy and identify modifiable risk factors, recognizing additional risk factors related to gender, genetic predisposition and especially the social-economic and cultural background in the pathogenesis of RVO, are the objectives that led to the planning of this study. In order to assess the prevalence of the disease and the current "clinical practice" we aim to create an online register between Italian specialist centers (ophthalmic emergency care and thrombosis centers) with immediate portability and usability of the data.

Conditions

Retinal Vein Occlusion

Keywords

Retinal Vein Occlusion; Atherosclerosis; Risk Factors; Major Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Retinal Venous Occlusion Prevalence

  The primary outcome result is about the description of RVO prevalence among the study population.

  Baseline

Secondary Outcomes (4)

• Atherosclerotic Risk Profile in RVO

  Baseline

• Visual Acuity

  2 Years

• Major Adverse Cardiovascular Events

  2 Years

• RVO Recurrence

  2 Years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with clinical suspicion of Retinal Venous Occlusion, consecutively enrolled at specialized ophthalmologic centers afferent to the study.

You may qualify if:

• Clinical Suspicion of Retinal Vein Occlusion
• Written Informed Consent

You may not qualify if:

• Pregnancy
• Short Life Expectancy

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Florence: collaborator

Study Sites (1)

Sapienza University of Rome - Policlinico Umberto I Roma

Rome, I, Italy

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion; Atherosclerosis

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Stefania Basili, MD

  University of Roma La Sapienza

  STUDY CHAIR

• Elena Pacella, MD

  University of Roma La Sapienza

  STUDY CHAIR

• Enzo M Vingolo, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

• Valeria Raparelli, MD, PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

• Marco Proietti, MD, PhD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Basili, MD

CONTACT

0649974678; stefania.basili@uniroma1.it

Elena Pacella, MD

CONTACT

elena.pacella@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 6, 2014
• Study Start: September 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

IT (1)