Hemianopsia Clinical Trial
— REVOIROfficial title:
Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia
| Verified date | December 2019 |
| Source | Fondation Ophtalmologique Adolphe de Rothschild |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 9 |
| Est. completion date | November 25, 2019 |
| Est. primary completion date | November 25, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Fondation Ophtalmologique Adolphe de Rothschild | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | change from baseline sensitivity at week 22 |
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