Assessing vision in preverbal children with eye conditions
Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children with Operable Bilateral Ocular Pathologies
This study is testing a new questionnaire to help doctors understand how well preverbal children with eye problems can see, so they can make better decisions about their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 0 Months to 36 Months |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT04428541 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a newly developed questionnaire designed to assess the visual function of preverbal children suffering from operable bilateral ocular pathologies. The questionnaire was created based on existing literature and expert opinions in the field of pediatric ophthalmology. The primary goal is to determine both the internal and external validity of this tool, which is crucial for making informed surgical decisions regarding treatment timing. By quantifying visual function in young children who cannot verbally communicate their vision status, the study seeks to improve clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 36 months diagnosed with operable bilateral ocular pathologies.
Not a fit: Patients with unilateral ocular pathology or those who are verbal and can express their vision will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better timing for surgical interventions in young children with eye conditions, potentially improving their visual outcomes.
How similar studies have performed: While there may be limited studies specifically targeting this age group with similar methodologies, the approach of using questionnaires for assessing visual function in children is a recognized area of interest in pediatric ophthalmology.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Paris
- Fondation A de Rothschild — Paris, France (Recruiting)
Study contacts
- Principal investigator: Pascal DUREAU, MD — Fondation A. de Rothschild
- Study coordinator: Amélie YAVCHITZ, MD
- Email: ayavchitz@for.paris
- Phone: (0)148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.