Understanding the real-life impact of rare eye diseases in children
Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
This study looks at how rare eye diseases affect the daily lives and feelings of children aged 8-18 and their families to help improve care and support for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 154 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06070467 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the real-life experiences of children aged 8-18 with rare eye diseases and their families. By employing a mixed methods research approach, it combines quantitative and qualitative tools to gather comprehensive data on the psychological and social impacts of severe visual impairment. The goal is to develop better evaluation tools that consider age and cultural differences, ultimately improving care and decision-making for affected families. The study seeks to fill existing gaps in knowledge regarding how these conditions affect children's quality of life.
Who should consider this trial
Good fit: Ideal candidates include children aged 8-18 with severe visual impairment as defined by WHO criteria, along with their parents or caregivers.
Not a fit: Patients with non-ophthalmic reasons for visual impairment or those unable to reliably respond to questions about their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and support for children with rare eye diseases, enhancing their quality of life.
How similar studies have performed: While there is limited information on similar studies, the approach of using mixed methods to capture patient experiences is gaining traction in the field, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Children, teenagers, and caregivers: 1. 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) 2. with functional or non-ophthalmic reasons of visual impairment 3. unable to provide consent/assent; 4. who do not speak/read the language
Where this trial is running
Strasbourg
- Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires — Strasbourg, France (Recruiting)
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.