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

Primary Purpose

Central or Peripheral Visual Impairment

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

microperimetry

visual acuity

automated visual field

eye movements recording

About this trial

This is an interventional other trial for Central or Peripheral Visual Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

central vision disorder

peripheral vision disorder

control

Arm Description

Outcomes

Primary Outcome Measures

Measurement of visual acuity (central versus peripheral)

Microperimetry recording (central versus peripheral)

recording of automated visual field (central versus peripheral)

recording of eye movements (central versus peripheral)

Secondary Outcome Measures

Measurement of visual acuity (patient versus control)

Microperimetry recording (patient versus control)

recording of automated visual field (patient versus control)

recording of eye movements (patient versus control)

Full Information

NCT ID

NCT03505398

First Posted

March 27, 2018

Last Updated

April 20, 2018

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03505398

Brief Title

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

Acronym

BEHAVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2018 (Anticipated)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central or Peripheral Visual Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

central vision disorder

Arm Type

Experimental

Arm Title

peripheral vision disorder

Arm Type

Experimental

Arm Title

control

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

microperimetry

Intervention Description

define the retinal fixation point and the differential sensitivity threshold of the retina.

Intervention Type

Procedure

Intervention Name(s)

visual acuity

Intervention Description

using ETDRS scales

Intervention Type

Procedure

Intervention Name(s)

automated visual field

Intervention Description

recording visual attention based on central or peripheral visual information

Intervention Type

Procedure

Intervention Name(s)

eye movements recording

Intervention Description

recording of explicit visual attention based on central or peripheral visual information

Primary Outcome Measure Information:

Title

Measurement of visual acuity (central versus peripheral)

Time Frame

Day 0

Title

Microperimetry recording (central versus peripheral)

Time Frame

Day 0

Title

recording of automated visual field (central versus peripheral)

Time Frame

Day 0

Title

recording of eye movements (central versus peripheral)

Time Frame

Day 0

Secondary Outcome Measure Information:

Title

Measurement of visual acuity (patient versus control)

Time Frame

Day 0

Title

Microperimetry recording (patient versus control)

Time Frame

Day 0

Title

recording of automated visual field (patient versus control)

Time Frame

Day 0

Title

recording of eye movements (patient versus control)

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guylène Le Meur, Pr

Phone

33 (0) 2 44 76 82 87

guylene.lemeur@chu-nantes.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Lebranchu, Dr

pierre.lebranchu@chu-nantes.fr

Facility Information:

Facility Name

CHU de Nantes

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre Lebranchu, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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