NCT03505398

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

5.1 years

First QC Date

March 27, 2018

Last Update Submit

January 31, 2024

Conditions

Central or Peripheral Visual Impairment

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

central vision disorder

EXPERIMENTAL
Procedure: microperimetryProcedure: visual acuityProcedure: automated visual fieldProcedure: eye movements recording

peripheral vision disorder

EXPERIMENTAL
Procedure: microperimetryProcedure: visual acuityProcedure: automated visual fieldProcedure: eye movements recording

control

OTHER
Procedure: microperimetryProcedure: visual acuityProcedure: automated visual fieldProcedure: eye movements recording

Interventions

microperimetryPROCEDURE

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

central vision disordercontrolperipheral vision disorder
visual acuityPROCEDURE

using ETDRS scales

central vision disordercontrolperipheral vision disorder
automated visual fieldPROCEDURE

recording visual attention based on central or peripheral visual information

central vision disordercontrolperipheral vision disorder
eye movements recordingPROCEDURE

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

central vision disordercontrolperipheral vision disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Interventions

Visual Acuity

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 23, 2018

Study Start

May 15, 2018

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

FR(1)