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

August 23, 2016 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

294

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

3 years to 17 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatients of pediatric ophthalmology will be included in the study. 50 patients will be included in each class of age: 3-4 years old; 5-7 years old; 8-17 years old.

For each class of age, 50 children with strabismus or amblyopa will be included, half of which treated by eye occlusion ; and 50 children with no strabismus nor amblyopia, half of which wearing glasses.

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
validation of the questionnaire
Time Frame: immediate
immediate

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe 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

Primary Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (ESTIMATE)

August 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBM_FAN_2013-7

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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