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

December 11, 2019 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate rehabilitation
Other: stimulation of the blind visual field
Other: delayed rehabilitation
Other: stimulation of the blind visual field

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the sensitivity of detection of a visual stimulus after rehabilitation
Time Frame: change from baseline sensitivity at week 22
change in the mean number of points where the sensitivity is lower than 15db in each contralesional hemifield, before and after rehabilitation
change from baseline sensitivity at week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Olivier GOUT, MD, Fondation OPH A de Rothschild
  • Study Director: Sylvie CHOKRON, Fondation OPH A de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2016

Primary Completion (Actual)

November 25, 2019

Study Completion (Actual)

November 25, 2019

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OGT_2015_16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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