Study of Visual-spatial Attention by Eye Tracking as a Function of Central or Peripheral Visual Impairment (BEHAVE)

Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment

The objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment.

Study Overview

• Status: Terminated
• Conditions: Central or Peripheral Visual Impairment
• Intervention / Treatment: Procedure: microperimetry; Procedure: visual acuity; Procedure: automated visual field; Procedure: eye movements recording

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female ≥18 years;
• Patient with a central visual deficit (central scotoma on the visual field: DMLA, cones dystrophy ...) or peripheral (annular scotoma: chronic glaucoma, retinitis pigmentosa ...) or without visual deficit (corrected visual acuity and visual field)
• Patient agreeing to participate in the study and signing informed consent
• Patient affiliated to social security

Exclusion Criteria:

• Pregnant woman
• Patient with known epilepsy
• Major under judicial safeguard, or deprived of liberty
• Major under guardianship or curatorship or admitted to a health or social institution for purposes other than research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control	Procedure: microperimetry; define the retinal fixation point and the differential sensitivity threshold of the retina.; Procedure: visual acuity; using ETDRS scales; Procedure: automated visual field; recording visual attention based on central or peripheral visual information; Procedure: eye movements recording; recording of explicit visual attention based on central or peripheral visual information
Experimental: central vision disorder	Procedure: microperimetry; define the retinal fixation point and the differential sensitivity threshold of the retina.; Procedure: visual acuity; using ETDRS scales; Procedure: automated visual field; recording visual attention based on central or peripheral visual information; Procedure: eye movements recording; recording of explicit visual attention based on central or peripheral visual information
Experimental: peripheral vision disorder	Procedure: microperimetry; define the retinal fixation point and the differential sensitivity threshold of the retina.; Procedure: visual acuity; using ETDRS scales; Procedure: automated visual field; recording visual attention based on central or peripheral visual information; Procedure: eye movements recording; recording of explicit visual attention based on central or peripheral visual information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of visual acuity (central versus peripheral)	Day 0
Microperimetry recording (central versus peripheral)	Day 0
recording of automated visual field (central versus peripheral)	Day 0
recording of eye movements (central versus peripheral)	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of visual acuity (patient versus control)	Day 0
Microperimetry recording (patient versus control)	Day 0
recording of automated visual field (patient versus control)	Day 0
recording of eye movements (patient versus control)	Day 0

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: RC17_0134; 2017-A00977-46 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No