Clinical Trials Directory

Trials / Completed

CompletedNCT04428541

Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
0 Months – 36 Months
Healthy volunteers
Not accepted

Summary

In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms. However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age. The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.

Conditions

Interventions

TypeNameDescription
OTHERQuestionnaire for visual function assessment of preverbal children18 items questionnaire

Timeline

Start date
2020-07-16
Primary completion
2025-05-21
Completion
2025-05-21
First posted
2020-06-11
Last updated
2025-12-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04428541. Inclusion in this directory is not an endorsement.