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NCT02880488 Clinical Trial

Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus

Amblyopia Clinical Trial

— ASTEQ  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02880488
Other study ID # RBM_FAN_2013-7
Secondary ID
Status Completed
Phase N/A
First received August 23, 2016
Last updated August 23, 2016

Study information
Verified date August 2016
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.

Recruitment information / eligibility
Status Completed
Enrollment 294
Est. completion date
Est. primary completion date July 2015
Accepts healthy volunteers
Gender Both
Age group 3 Years to 17 Years
Eligibility Inclusion Criteria:

- children with a status of strabismus or not strabismus made by a specialized ophthalmologist

- children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist

- signed consent of parents

Exclusion Criteria:

- ocular pathology (except for isolated ametropia)

- evolutive paralytic strabismus

- antecedent of surgery for strabismus

- strabismus surgery in the past 6 months

- disease with possible impact on the child's answers, such as severe neurologic troubles)

- poor knowledge of French language

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary validation of the questionnaire immediate No
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