NCT02880488

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

First QC Date

August 23, 2016

Last Update Submit

August 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • validation of the questionnaire

    immediate

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

AmblyopiaStrabismus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve Diseases

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Primary Completion

July 1, 2015

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations