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Status unknownNCT02257333HEART-VISIONUpdated Dec 13, 2018

Retinal Thrombosis and Atherosclerosis

An observational study in Retinal Vein Occlusion, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by University of Roma La Sapienza · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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 occlusion of a branch of the central retinal vein (BRVO) and central retinal vein occlusion (CRVO) are two topics discussed and very deserving of further study, especially for the need of greater clarity arising from the availability of new diagnostic and especially therapeutic opportunities.

The literature on the prevalence of RVO is not particularly rich, and the results of the available studies are very heterogeneous because such studies are conducted on a few cases, using different methodologies and are mainly characterized by a different distribution of risk factors among the different populations. In this regard, it was particularly interesting a publication of 2010 which proposed a combined analysis of the main study population (population based study).

The sample of the final analysis was of 49 869 subjects, and the results showed that the retinal vein occlusion overall prevalence, standardized for age and sex, is 5.2 per 1000, of which 4.42 and 0.80 to BRVO and CRVO respectively. Despite the slightly higher prevalence in females, this difference wasn't statistically significant.

In contrast, the prevalence of venous occlusion increases with increasing age in a statistically significant manner, both in the overall analysis of the occlusions of branch and central, that for the individual entities. This pattern is characteristic of chronic degenerative diseases and in fact the RVO has a behavior very similar to that of these diseases, probably because the risk factors (especially those such as atherosclerosis and systemic hypertension) increases with age.

The results provided by these systematic analysis are particularly important because they provide a reliable estimate of RVO prevalence in general population; must be considered, however, the inherent limitations mainly concerning potential sources of heterogeneity, such as different methodologies used, the fact that most of the studies were carried out on a single ethnic group, often with different distribution of risk factors and therefore were not suitable to capture these differences.

The risk factors predisposing 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 disease can be consequent to atherosclerosis and therefore caused by arterial disease rather than the pathogenesis of venous disease.

There is a very variable delay between the onset of symptoms and initiation of treatment; the excessive delay of treatment was considered an exclusion criterion in only a minority of the studies considered. Although it is very difficult to estimate the age of the thrombotic event, early identification is surely preferable and the treatment time is a critical factor to evaluate the efficacy of a therapeutic strategy. Because of the relatively small number of patients is not possible to determine which therapy is more effective.

Recently new experimental therapeutic approaches have been proposed, such as intravitreal administration of various drugs (steroids, anti-VEGF). It is not yet clear whether these approaches can eliminate the need for anticoagulant therapy during the acute phase of the disease. Surely antithrombotic drugs may have a role in the treatment of the acute phase of the RVO, at least in some categories of patients, and can be used in association with intravitreal drugs. Future studies should also explore the possibility of combined approaches. The retinal vein occlusion is a disease related to age and surely there will be an increase in social-economic impact of this disease due to the increase in population of the most advanced age group.

To assess the social-economic impact should be considered in addition to visual impairment related to the disease, the impact on quality of life of the patient and the direct medical costs of retinal vein thrombosis have shown that in one year a patient with this disease has an average cost 20% higher than a hypertensive patient (BRVO: + 16%; CRVO: + 22%) or glaucoma ones (BRVO: + 18%; CRVO: + 24%); Therefore, although it is less frequent than the other diseases RVO affects considerably on health care costs. The data available in the literature show that in the overall one year management, direct costs that have the greatest impact, in percentage terms, are the costs associated with ocular pathology caused by acute event (thrombosis) and diagnostic tests. After three years, however, the cost is linked to systemic disease (hospitalization) has a bigger impact in percentage terms, as if to indicate that retinal vein thrombosis is nothing more than an epiphenomenon of systemic disease.

Operating Modes The study will be divided into 4 phases: Step 1: establishment of the network: identification of specialized facilities (ophthalmic emergency care and thrombosis centers), which may accept patients with suspected RVO, which will participate in the establishment of the register online; Step 2: Create the registry and recruitment of patients cohort; Step 3: Follow-up planned (1 month) for instrumental tests to confirm the diagnosis of RVO; Step 4: Observational follow-up supported by dedicated web platform for the identification of major adverse cardiovascular events, in order to export in the context of clinical acquisitions epidemiological and disease management in real time.

02

Conditions studied

  • Retinal Vein Occlusion

Keywords

  • Retinal Vein Occlusion
  • Atherosclerosis
  • Risk Factors
  • Major Adverse Cardiovascular Events
03

In context

Retinal Vein Occlusion

282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 122 across 62 observational studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Clinical Suspicion of Retinal Vein Occlusion
  • Written Informed Consent

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Short Life Expectancy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Retinal Venous Occlusion Prevalence

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

    Time frame: Baseline

Secondary outcomes

  1. Atherosclerotic Risk Profile in RVO

    The second primary outcome is to identify and describe the atherosclerotic burden and the atherosclerosis risk factors prevalence among RVO patients.

    Time frame: Baseline

  2. Visual Acuity

    To evaluate visual acuty in a long time frame after RVO. Visual acuity will be assessed according to Snellen and ETDRS scales.

    Time frame: 2 Years

  3. Major Adverse Cardiovascular Events

    Evaluate incidence and prevalence of MACE among patients with RVO

    Time frame: 2 Years

  4. RVO Recurrence

    It will be evaluated wheter the first RVO episode could be a risk factor for the occurence of a new RVO.

    Time frame: 2 Years

07

Study locations

1 of 1 sites recruiting
  • Sapienza University of Rome - Policlinico Umberto I Roma
    Rome, I, Italy
    • Stefania Basili, MD · Contact · stefania.basili@uniroma1.it · +390649974678
    • Stefania Basili, MD · Principal investigator
    • Elena Pacella, MD · Principal investigator
    • Valeria Raparelli, MD · Sub investigator
    • Marco Proietti, MD · Sub investigator
    • Laura Napoleone, MD · Sub investigator
    • Roberto Cangemi, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02257333
Lead sponsor
University of Roma La Sapienza
Collaborators
University of Florence
Responsible party
Stefania Basili (Associate Professor, University of Roma La Sapienza) — Principal investigator
First posted
Oct 6, 2014
Start date
Sep 1, 2015
Primary completion
Sep 2019 (estimated)
Completion
Sep 2020 (estimated)
Last update
Dec 13, 2018

Study contacts

Stefania Basili, MD
Contact
stefania.basili@uniroma1.it
0649974678 ext. +39
Elena Pacella, MD
Contact
elena.pacella@uniroma1.it
Stefania Basili, MD
study chair · University of Roma La Sapienza
Elena Pacella, MD
study chair · University of Roma La Sapienza
Enzo M Vingolo, MD
principal investigator · University of Roma La Sapienza
Valeria Raparelli, MD, PhD
principal investigator · University of Roma La Sapienza
Marco Proietti, MD, PhD
principal investigator · University of Roma La Sapienza

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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