Visual Cognitive Deficits Clinical Trial
Official title:
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
Visual cognitive deficits in children are frequent, with an impact on working and daily
activities. Optometric therapy may improve those functions, however few studies have been
performed.
We aim to evaluate the efficacy of such therapy by a comparative study between two groups of
children aged between 5 and 12 after 6 months of rehabilitation.
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | June 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 12 Years |
| Eligibility |
Inclusion Criteria: - visual cognitive deficits - normal intelligence Exclusion Criteria: - cerebral palsy - mental deficiency - visual acuity deficit |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CRTLA - Hôpital de Hautepierre- CHRU Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Quality of life | Quality of life assessed by a questionnaire at V0, V1 and V2. | Visit 2 (12 months of rehabilitation) | No |
| Primary | Calculation of a composite score at Visit 1 | The composite score is calculated from the results obtained at several neuropsychology and optometric tests. Basal score is calculated at Visit 0 (inclusion visit). |
Visit 1 (6 months of rehabilitation) | No |
| Secondary | Calculation of a composite score at Visit 2 | The composite score is calculated from the results obtained at several neuropsychology and optometric tests. | Visit 2 (12 months of rehabilitation) | No |