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

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ClinicalTrials.gov Identifier: NCT03505398
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date April 23, 2018
Estimated Study Start Date  ICMJE April 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Measurement of visual acuity (central versus peripheral) [ Time Frame: Day 0 ]
  • Microperimetry recording (central versus peripheral) [ Time Frame: Day 0 ]
  • recording of automated visual field (central versus peripheral) [ Time Frame: Day 0 ]
  • recording of eye movements (central versus peripheral) [ Time Frame: Day 0 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
  • Measurement of visual acuity (patient versus control) [ Time Frame: Day 0 ]
  • Microperimetry recording (patient versus control) [ Time Frame: Day 0 ]
  • recording of automated visual field (patient versus control) [ Time Frame: Day 0 ]
  • recording of eye movements (patient versus control) [ Time Frame: Day 0 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Visual-spatial Attention by Eye Tracking as a Function of Central or Peripheral Visual Impairment
Official Title  ICMJE Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Central or Peripheral Visual Impairment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: central vision disorder
    Interventions:
    • Procedure: microperimetry
    • Procedure: visual acuity
    • Procedure: automated visual field
    • Procedure: eye movements recording
  • Experimental: peripheral vision disorder
    Interventions:
    • Procedure: microperimetry
    • Procedure: visual acuity
    • Procedure: automated visual field
    • Procedure: eye movements recording
  • control
    Interventions:
    • Procedure: microperimetry
    • Procedure: visual acuity
    • Procedure: automated visual field
    • Procedure: eye movements recording
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505398
Other Study ID Numbers  ICMJE RC17_0134
2017-A00977-46 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP