Eye DiseasesSeeMyLifeNCT06070467
Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
An observational study of Eye Diseases and Severe Loss of Vision, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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 their lives and their families. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Severe Loss of Vision, Blindness
- What is being tested?
- Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) tools
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires
Strasbourg, 67091
Hélène DOLLFUS, MD, 33.3.88.12.81.20, helene.dollfus@chru-strasbourg.fr
Hélène DOLLFUS, MD
About this study
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 their lives and their families. Understanding this impact, at a patient centred level, is key in care, in shared decision making, in developing therapies, and in improving social integration and participation about the standard rules of the United Nations (UN) and the European Union (EU) (prevention, non-discrimination, equal opportunities, accessibility, etc.). However, current tools to evaluate vision related (VR) quality of life (QoL) VR-QoL disregard age and cultural differences. There is a lack knowledge on how the disease matters at child's level. Instruments capable of yielding high-quality data, psychometrically robust and comply with regulatory requirements remain to be developed.
To fill this gap, SeeMyLife will use multilevel concurrent mixed method research combining quantitative studies and qualitative studies. The quantitative approach is based on (i) cross culturally translated validated VR-QoL questionnaires for children and teenagers (Functional Vision Questionnaire for Children and Young People - FVQ-CYP and Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP) and (ii) on caregiver's questionnaires addressing participation and environment (Participation and Environment Measure - Children and Youth - PEM-CY). To fully capture the picture of the child/teenager personal life the investigators will reinforce their investigations by in depth qualitative socio-anthropologic study with semi directive field interviews and fieldwork (to observe closely the living conditions of the children) to address how their impairment affects their wellbeing, social integration, and how they feel about medical and social interventions. Data analysis will use an integrated mixed method strategy to validate the quantitative tools and deliver a holistic QoL transnational tool.
The SeeMyLife project will provide (i) robust patient self-reported tools that will be then used in care and research (especially with the rise in novel therapies) as a standard as well as (ii) highly awaited knowledge about the SVI/B patient's position within his own life course, within his family and in relation to health and social care actors.
- Conditions
- Eye Diseases, Severe Loss of Vision, Blindness, Quality of Life
- Being tested
- Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) tools
- Medical subject headings
- Eye Diseases, Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) toolsOther
A Mixed Methods Research (MMR) using quantitative (QUAN) Vision Related-QoL (VR-QoL = FVQ-CYP and VQoL-CYP) tools and psychosocial PEM-CY, and qualitative (QUAL) socio-anthropologic investigations can capture reliably children's and teenagers' Patient-Reported Outcome (PRO).
The QUAN study is a cross-sectional study including short-term re-test repetition (children/teenagers only) using the following PROMs for children/teenagers:
- Self-reported questionnaires for patients (FVQ-CYP and VQoL-CYP)
- For caregivers: PEM-CY questionnaires
The QUAL study will rely on the following instruments:
- Semi-directive interviews,
- Focus groups,
- Field observation.
| Study group | Role | What they receive |
|---|---|---|
| children and teenagers affected by Rare Eye Diseases | A Mixed Methods Research (MMR) using quantitative (QUAN) Vision Related-QoL (VR-QoL = FVQ-CYP and VQoL-CYP) tools and psychosocial PEM-CY, and qualitative (QUAL) socio-anthropologic investigations can capture reliably children's and teenagers' Patient-Reported Outcome (PRO). Receives: Other: Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
real-life impact of SVI/B in children and teenagers affected by Rare Eye Diseases
To elucidate whether Patient-Reported Outcome Measures (PROMs) reflect how children/teenagers perceive their lives to be impacted by Rara Eye Diseases using Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start17 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070467
- Sponsor's protocol ID
- 8826
- Acronym
- SeeMyLife
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2023
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
- ClinicalTrials.gov ID
- NCT06070467
- Acronym / sponsor ID
- SeeMyLife / 8826
- Conditions
- Eye Diseases, Severe Loss of Vision, Blindness, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 their lives and their families. Understanding this impact, at a patient centred level, is key in care, in shared decision making, in developing therapies, and in improving social integration and participation about the standard rules of the United Nations (UN) and the European Union (EU) (prevention, non-discrimination, equal opportunities, accessibility, etc.). However, current tools to evaluate vision related (VR) quality of life (QoL) VR-QoL disregard age and cultural differences. There is a lack knowledge on how the disease matters at child's level. Instruments capable of yielding high-quality data, psychometrically robust and comply with regulatory requirements remain to be developed.
To fill this gap, SeeMyLife will use multilevel concurrent mixed method research combining quantitative studies and qualitative studies. The quantitative approach is based on (i) cross culturally translated validated VR-QoL questionnaires for children and teenagers (Functional Vision Questionnaire for Children and Young People - FVQ-CYP and Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP) and (ii) on caregiver's questionnaires addressing participation and environment (Participation and Environment Measure - Children and Youth - PEM-CY). To fully capture the picture of the child/teenager personal life the investigators will reinforce their investigations by in depth qualitative socio-anthropologic study with semi directive field interviews and fieldwork (to observe closely the living conditions of the children) to address how their impairment affects their wellbeing, social integration, and how they feel about medical and social interventions. Data analysis will use an integrated mixed method strategy to validate the quantitative tools and deliver a holistic QoL transnational tool.
The SeeMyLife project will provide (i) robust patient self-reported tools that will be then used in care and research (especially with the rise in novel therapies) as a standard as well as (ii) highly awaited knowledge about the SVI/B patient's position within his own life course, within his family and in relation to health and social care actors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children and teenagers affected by Rare Eye Diseases | – | Other: Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) toolsA Mixed Methods Research (MMR) using quantitative (QUAN) Vision Related-QoL (VR-QoL = FVQ-CYP and VQoL-CYP) tools and psychosocial PEM-CY, and qualitative (QUAL) socio-anthropologic investigations can capture reliably children's and teenagers' Patient-Reported Outcome (PRO). |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Children, teenagers, and caregivers:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) toolsA Mixed Methods Research (MMR) using quantitative (QUAN) Vision Related-QoL (VR-QoL = FVQ-CYP and VQoL-CYP) tools and psychosocial PEM-CY, and qualitative (QUAL) socio-anthropologic investigations can capture reliably children's and teenagers' Patient-Reported Outcome (PRO). The QUAN study is a cross-sectional study including short-term re-test repetition (children/teenagers only) using the following PROMs for children/teenagers: 1. Self-reported questionnaires for patients (FVQ-CYP and VQoL-CYP) 2. For caregivers: PEM-CY questionnaires The QUAL study will rely on the following instruments: 1. Semi-directive interviews, 2. Focus groups, 3. Field observation. | Other | children and teenagers affected by Rare Eye Diseases |
Primary outcome
real-life impact of SVI/B in children and teenagers affected by Rare Eye Diseases
Time frame: 12 months
To elucidate whether Patient-Reported Outcome Measures (PROMs) reflect how children/teenagers perceive their lives to be impacted by Rara Eye Diseases using Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
Related trials for Eye Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases and Severe Loss of Vision, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
real-life impact of SVI/B in children and teenagers affected by Rare Eye Diseases (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.