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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04428541

Acronym

EVEIL

Enrollment

150

Registered

2020-06-11

Start date

2020-07-16

Completion date

2025-05-21

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases, Vision Disorders

Keywords

Eye Diseases, Vision Disorders, Questionnaire Design, Children, Infant

Brief 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.

Interventions

OTHERQuestionnaire for visual function assessment of preverbal children

18 items questionnaire

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Months to 36 Months

Healthy volunteers

Inclusion criteria

Common to the three groups: * Patient aged 0 to 36 months * Diagnosis of known ocular pathology For patients targeted by the questionnaire: \- Patient with operable bilateral ocular pathology For negative controls: \- Patient without ocular pathology inducing a decrease in vision For positive controls: * Patient with inoperable bilateral ocular pathology * Patient without light perception

Exclusion criteria

* Patient with unilateral ocular pathology * Verbal patients (able to express themselves through speech)

Design outcomes

Primary

Measure	Time frame	Description
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children	Inclusion	Reliability evaluated by Cronbach's alpha coefficient and its 95% confidence interval. unabbreviated scale title : Assessment of Visual Function in Preverbal Children in Bilateral Ocular Pathology Minimum value : 0 Maximum value : 18 Higher scores mean better outcome

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026