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Search / Trial NCT04428541

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

Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · Jun 10, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Eye Diseases Vision Disorders Questionnaire Design Children Infant

ClinConnect Summary

This clinical trial is investigating a new questionnaire designed to help doctors understand the vision of very young children who have certain eye conditions. Because these children cannot yet speak, it can be challenging to determine the right time for surgery to improve their vision. The researchers have created this questionnaire based on expert opinions and existing studies to better assess how well a child's eyes are working. The goal is to ensure that when surgery is needed, it is done at the most appropriate time.

To participate in this study, children must be between 0 and 36 months old and have a known eye condition that can be treated with surgery. The study is looking for children with operable bilateral eye problems, as well as those with inoperable conditions or no vision problems at all for comparison. Families who join the study will help researchers test the validity of the questionnaire, meaning they will see how accurately it measures a child's vision. This could ultimately lead to better treatment decisions for young children with eye diseases.

Gender

ALL

Eligibility 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)

About Fondation Ophtalmologique Adolphe De Rothschild

The Fondation Ophtalmologique Adolphe de Rothschild is a leading French institution dedicated to advancing ophthalmic research and patient care. Renowned for its commitment to innovation in eye health, the foundation conducts cutting-edge clinical trials aimed at improving treatments for various ocular conditions. With a multidisciplinary team of experts, the foundation collaborates with academic and industry partners to enhance understanding of eye diseases and develop novel therapeutic solutions, ultimately striving to improve patient outcomes and quality of life in ophthalmology.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Pascal DUREAU, MD

Principal Investigator

Fondation A. de Rothschild

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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