Clinical trial NCT04447599: Conjunctival and Retinal Vascularization and Small Vessel Disease
Official title: Study of Conjunctival and Retinal Blood Vessels for the Evaluation of the Load of Small Vessel Disease in Patients With Transient Ischemic Attacks (TIAs) and Minor Strokes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Stroke
Keywords: small vessel disease
STRIVE recommendations
artificial intelligence in " deep learning "
bulbar conjunctiva photography
MRI
screening
fundus
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 850
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to use a simple photography of conjunctival vessels to search for an association between conjunctival vessels abnormalities and the load of small vessel disease as quantified by MRI in patients with TIA s and minor strokes.

The artificial intelligence (AI) tools will permit to classify abnormalities of conjunctival vessels that predict the load of small vessel disease in TIAs and strokes.

Detailed description: Small vessel disease is a risk factor of ischemic or hemorrhagic stroke and a direct cause of lacunar and hemorrhagic infarcts. Moreover, it is associated of cognitive impairment, like psychomotor retardation, deficits of attention, planning, and set-shifting, and dysexecutive syndrome.

This disease affects the cerebral vessels of small diameters. Magnetic Resonance Imaging (MRI) is the gold standard for the diagnosis and the screening of this pathology. However it is an imaging with limit access and high cost.

Vessels of bulbar conjunctiva have a small caliber like the small cerebral vessels and have the same origin: carotid arteries. They are easy to study with photography. The analysis of these vessels may be a new way of screening the small vessel disease, easier to use than MRI.

Retinal vascularization is also easier to study with photography of fundus without dilatation by retinograph. Several studies already demonstrated an association between retinal abnormalities and load of small vessel disease. However, no relation was established between these modification and impairment of conjunctival vascularization in this cerebral pathology although those have the same arterial origin and vascular diameters.

The strategy is to take a picture of temporal bulbar conjunctiva and fundus for patients with symptoms of TIA and minor stroke with all etiologies. Patients will be classified according to Fazekas staging and presence of lacunar infarcts. First, photography of bulbar conjunctiva will be analyzed by an artificial intelligence in " deep learning " to demonstrate a correlation between abnormalities of conjunctival vessels and staging of small cerebral disease. After that, photography of fundus will be analyzed with the same AI to search a correlation between conjunctival and retinal vascularization in small vessel disease.

The present study will include patients with symptoms of TIAs and minor strokes coming at clinic of TIA in University Hospital Toulouse. A consultation by a neurologist will be done, than MRI will be prescribed for each of them. After a therapeutic care, they will go to the ophthalmologist for a photo of their bulbar conjunctival of each eye and photography of fundus without dilatation. The follow up will be realized the same day.

Eligibility criteria: Inclusion Criteria:

* Patients treated for a minor stroke or transient ischemic attack justifying an MRI.

Exclusion Criteria:

* Severe eye dryness with conjunctiva hyperhemia,
* Taking eye treatments for glaucoma
* Inflammatory or infectious eye damage resulting in conjunctiva hyperhemia: conjunctivitis, herpetic keratitis, ulcer, abscess, uveitis, peripheral ulcerative keratitis, interstitial keratitis, scleritis, episcleritis, pingueculitis, scarring eye pemphigoide, acute seizure by closing of the angle,
* History of eye surgery. Among eye surgeries, those that can modify the conjunctiva are strabismus surgeries, glaucoma, conjunctiva resection surgery (pterygial or tumor) or wound surgery or finally recent cataract surgery (2 years).
* Persons under the legal protection of adults (safeguarding justice, guardianship, curatorship, institutionalized, or under mandate of future protection)
* Administrative problems: inability to give about informed information, no coverage by a social security plan, refusal to sign a consent.

Primary outcomes:
measure: Numbers of conjunctival vascular abnormalities
timeFrame: day 1
Secondary outcomes:
measure: Classification of different types of vascular abnormalities in different grades of small vessel disease
timeFrame: Day 1
measure: Absence of difference between the 2 eyes
timeFrame: Day 1
measure: same stade of vascular abnormalities
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: NASR Nathalie
Study officials:
affiliation: University Hospital, Toulouse
name: Nathalie NASR, MD
role: PRINCIPAL_INVESTIGATOR
References: