Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03505398
Recruitment Status : Unknown
Verified April 2018 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Central or Peripheral Visual Impairment Procedure: microperimetry Procedure: visual acuity Procedure: automated visual field Procedure: eye movements recording Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Measurement of visual acuity (central versus peripheral) [ Time Frame: Day 0 ]
  2. Microperimetry recording (central versus peripheral) [ Time Frame: Day 0 ]
  3. recording of automated visual field (central versus peripheral) [ Time Frame: Day 0 ]
  4. recording of eye movements (central versus peripheral) [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Measurement of visual acuity (patient versus control) [ Time Frame: Day 0 ]
  2. Microperimetry recording (patient versus control) [ Time Frame: Day 0 ]
  3. recording of automated visual field (patient versus control) [ Time Frame: Day 0 ]
  4. recording of eye movements (patient versus control) [ Time Frame: Day 0 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505398


Contacts
Layout table for location contacts
Contact: Guylène Le Meur, Pr 33 (0) 2 44 76 82 87 guylene.lemeur@chu-nantes.fr
Contact: Pierre Lebranchu, Dr pierre.lebranchu@chu-nantes.fr

Locations
Layout table for location information
France
CHU de Nantes
Nantes, France, 44000
Contact: Pierre Lebranchu, Dr         
Sponsors and Collaborators
Nantes University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03505398    
Other Study ID Numbers: RC17_0134
2017-A00977-46 ( Other Identifier: ANSM )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vision Disorders
Vision, Low
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Eye Diseases