Conjunctival and Retinal Vascularization and Small Vessel Disease

NCT04447599 | Unknown

• 1 other identifier: RC31/20/0001
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Stroke

Keywords

small vessel disease; STRIVE recommendations; artificial intelligence in " deep learning "; bulbar conjunctiva photography; MRI; screening; fundus

Outcome Measures

Primary Outcomes (1)

• Numbers of conjunctival vascular abnormalities

  Association between numbers of conjunctival vascular abnormalities and the load of small cerebral disease highlighted by neural network in " deep learning ". This outcome is collected after the end of the inclusion of all patients.

  day 1

Secondary Outcomes (3)

• Classification of different types of vascular abnormalities in different grades of small vessel disease

  Day 1

• Absence of difference between the 2 eyes

  Day 1

• same stade of vascular abnormalities

  Day 1

Study Arms (1)

Photographs

EXPERIMENTAL

Photographs

Other: photography of conjunctival vessels

Interventions

photography of conjunctival vessels OTHER

patient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation

Photographs

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

NASR Nathalie

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nathalie NASR, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie NASR, MD

CONTACT

05 61 77 56 02; nasr.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: June 25, 2020
• Study Start: October 20, 2020
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

FR (1)