Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections

Central retinal vein occlusion (CRVO) is the second most common retinal vascular disease after diabetic retinopathy. It induces circulatory slowdown and blood stasis, which can appear as retinal hemorrhages. CRVO has been classically separated into two clinical forms: ischemic CVRO (possibly associated with cotton wool spots) and non-ischemic CRVO, the former being considered the most serious due to neovascular complications. More recently, a new classification has been suggested by Pierru et al. distinguishing two types of CRVO: type A characterized by low acute blood flow and type B with a slower onset. Type A is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. Type B is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination.

A retrospective study had shown a slight difference in favor of pulsatile CRVO in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. However, no statistically significant difference was observed.

The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (SPARs) in patients with type A or B CRVO can be considered as a prognostic factor for the evolution of CRVO.

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Key information

Conditions

Central Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Fondation A. de Rothschuld, Paris, France

About this study

In order to be able to interpret the results on a homogeneous population, given that several molecules have marketing authorization for the management of macular edema following a CRVO, the therapeutic management will be standardized by the use of aflibercept for patients requiring intravitreal injection, aflibercept being the most widely referenced treatment currently used in the participating centers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of CRVO, with or without macular edema.
Onset of symptoms in the previous month (maximum 30 days prior to inclusion)
Naive of intravitreal injection and intravitreal corticosteroid implant
If woman of childbearing age: commitment to effective contraception during treatment with aflibercept and for at least 3 months after the last intravitreal injection of aflibercept

Exclusion criteria

Pregnant or breastfeeding woman
History of stroke or myocardial infarction in the last 3 months
Retinal detachment or untreated retinal dehiscence
Opacity of ocular media
Amblyopia
Diabetic retinopathy
Macular edema of a different etiology than CRVO
Active or suspected ocular or periocular infection
Severe intraocular inflammation
Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients

Treatment and study plan

Ophthalmologic exam at inclusion and 12 months after CRVO

Other

As part of routine care : OCT-B (Optical coherence tomography-B), OCT-angiography (Optical coherence tomography and fluorescein angiography after pupillary dilatation (at inclusion only)

Added by the study :

Assessment of best corrected visual acuity in letters read and validated using the ETDRS scale ;
The shooting of a 10 second infrared movie by the Heidelberg Spectralis device centered on the head of the optic nerve (at inclusion only)
A measurement of the eye tension with an air tonometer (at inclusion only)
A blood pressure measurement (diastolic and systolic) and pulse measurement (at inclusion only)
A color retinophotography (Optos) with autofluorescence images
A color Doppler ultrasound of the optic nerve of both eyes will be performed, for patients treated at the Foundation A de Rothschild Hospital only.

Treatment standardization with aflibercept

Drug

For patients requiring intravitreal injection

Primary outcomes

Change in visual acuity between inclusion and visit at one year compared between patients with SPARs versus without SPARs

Time frame: At inclusion and 12 months after CRVO

Evolution of best corrected visual acuity on ETDRS scale (Early treatment diabetic retinopathy study scale) in letters read and validated Infrared movies will be made at inclusion from the Heidelberg Spectralis device. Two ophthalmologists blinded to each other will view the films. The arterial pulses are visualized at the optic disc site in the form of pulse-dependent beats of the arterial walls. For each movie each ophthalmologist will give his assessment: SPARs+ or SPARs-. In case of discrepancy, a third ophthalmological opinion will be requested.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

Bayer

Registry information

Acronym: PULSOV

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Mar 11, 2021
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed