Status:

RECRUITING

Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases

Lead Sponsor:

University Hospital, Strasbourg, France

Conditions:

Eye Diseases

Severe Loss of Vision

Eligibility:

All Genders

8+ years

Brief Summary

Rare Eye Diseases (RED) are the leading cause of severe visual impairment/ blindness (SVI/B) in children in Europe. This sensory disability with its accompanying psychological distress hugely impacts ...

Eligibility Criteria

Inclusion

  • Children (age 8-12) and teenagers (age 13-18) with various levels of visual impairment defined according to World Health Organization (WHO) International Classification of Diseases (ICD) 10 - WHO ICD 10 \[best-corrected visual acuity ≤ 0.3 decimal or ≤ 6/18\], and their parents/caregivers.

Exclusion

  • Children, teenagers, and caregivers:
  • who lack the ability to respond in a reliable way to the questions on how they feel about their visual impairment (patients with mild intellectual or cognitive deficiency may be able to reply accurately as opposed to cases with severe intellectual disability)
  • with functional or non-ophthalmic reasons of visual impairment
  • unable to provide consent/assent;
  • who do not speak/read the language

Key Trial Info

Start Date :

July 17 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

154 Patients enrolled

Trial Details

Trial ID

NCT06070467

Start Date

July 17 2024

End Date

July 1 2026

Last Update

August 29 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires

Strasbourg, France, 67091