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TerminatedNCT02886663REVOIRUpdated Dec 13, 2019

Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

An interventional study of stimulation of the blind visual field in Hemianopsia, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-13.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Other

Why this study was terminated
Major inclusion difficulties
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hemianopsia

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In context

Hemianopsia

63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.

This study's enrollment of 9 is below the median of 32 across 53 interventional studies indexed under Hemianopsia.

Browse Hemianopsia studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Browse Fondation Ophtalmologique Adolphe de Rothschild studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    immediate rehabilitation

    Other: stimulation of the blind visual field

  • Other
    delayed rehabilitation

    Other: stimulation of the blind visual field

Interventions

  • Otherstimulation of the blind visual field
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What researchers measure

Primary outcomes

  1. 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

    Time frame: change from baseline sensitivity at week 22

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Study locations

1 site
  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, 75019, France
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Nov 2019, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2016
First posted
Sep 1, 2016
StartActual
Dec 13, 2016
Primary completionActual
Nov 25, 2019
CompletionActual
Nov 25, 2019
Last update
Dec 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02886663
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Sep 1, 2016
Start date
Dec 13, 2016
Primary completion
Nov 25, 2019
Completion
Nov 25, 2019
Last update
Dec 13, 2019

Study contacts

Sylvie CHOKRON
study director · Fondation OPH A de Rothschild
Olivier GOUT, MD
principal investigator · Fondation OPH A de Rothschild

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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