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Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia (REVOIR)

Primary Purpose

Hemianopsia

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

stimulation of the blind visual field

About this trial

This is an interventional other trial for Hemianopsia

Eligibility Criteria

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

Inclusion Criteria:

Presence of an homonymous visual field amputation after vascular retrochiasmatic lesion of the occipital region (visual cortex alone or with optical radiations or with other associated occipital areas)
inclusion 3 months to 36 months after stroke
Patients aged 18 years and older

Exclusion criteria:

Brain injury history
Severe neuropsychological, psychiatric or behavioral disorder
Severe eye disorder or visual impairment (visual acuity less than 3/10)
Progressive eye disorder (cataracts or glaucoma)
insufficient French language proficiency to understand the questionnaires and rehabilitation tasks
patient under legal protection
patient's opposition to participate in the study
no medical insurance coverage
pregnant pr breastfeeding patient

Sites / Locations

Fondation Ophtalmologique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

immediate rehabilitation

delayed rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

change in the sensitivity of detection of a visual stimulus after rehabilitation

change in the mean number of points where the sensitivity is lower than 15db in each contralesional hemifield, before and after rehabilitation

Secondary Outcome Measures

Full Information

NCT ID

NCT02886663

First Posted

August 29, 2016

Last Updated

December 11, 2019

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

1. Study Identification

Unique Protocol Identification Number

NCT02886663

Brief Title

Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

Acronym

REVOIR

Official Title

Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Why Stopped

Major inclusion difficulties

Study Start Date

December 13, 2016 (Actual)

Primary Completion Date

November 25, 2019 (Actual)

Study Completion Date

November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the cerebral localization and in 60% of stroke interesting the territory of the posterior cerebral artery.

6. Conditions and Keywords

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

Hemianopsia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

immediate rehabilitation

Arm Type

Experimental

Arm Title

delayed rehabilitation

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

stimulation of the blind visual field

Primary Outcome Measure Information:

Title

change in the sensitivity of detection of a visual stimulus after rehabilitation

Description

change in the mean number of points where the sensitivity is lower than 15db in each contralesional hemifield, before and after rehabilitation

Time Frame

change from baseline sensitivity at week 22

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Presence of an homonymous visual field amputation after vascular retrochiasmatic lesion of the occipital region (visual cortex alone or with optical radiations or with other associated occipital areas) inclusion 3 months to 36 months after stroke Patients aged 18 years and older Exclusion criteria: Brain injury history Severe neuropsychological, psychiatric or behavioral disorder Severe eye disorder or visual impairment (visual acuity less than 3/10) Progressive eye disorder (cataracts or glaucoma) insufficient French language proficiency to understand the questionnaires and rehabilitation tasks patient under legal protection patient's opposition to participate in the study no medical insurance coverage pregnant pr breastfeeding patient

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvie CHOKRON

Organizational Affiliation

Fondation OPH A de Rothschild

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Olivier GOUT, MD

Organizational Affiliation

Fondation OPH A de Rothschild

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondation Ophtalmologique Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

12. IPD Sharing Statement

Learn more about this trial

Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

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