AmblyopiaASTEQNCT02880488
Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus
An observational study of Amblyopia and Strabismus, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Amblyopia, Strabismus
- How many people
- 294 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Jul 2015
- 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 3 to 17 years
- All sexes
- Child
Study population: Outpatients of pediatric ophthalmology will be included in the study. 50 patients will be included in each class of age: 3-4 years old; 5-7 years old; 8-17 years old. For each class of age, 50 children with strabismus or amblyopa will be included, half of which treated by eye occlusion ; and 50 children with no strabismus nor amblyopia, half of which wearing glasses.
Who may be able to join
- children with a status of strabismus or not strabismus made by a specialized ophthalmologist
- children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist
- signed consent of parents
Who cannot join
- ocular pathology (except for isolated ametropia)
- evolutive paralytic strabismus
- antecedent of surgery for strabismus
- strabismus surgery in the past 6 months
- disease with possible impact on the child's answers, such as severe neurologic troubles)
- poor knowledge of French language
Trial locations and contacts
1 site in 1 country.
About this study
The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.
- Conditions
- Amblyopia, Strabismus
- Medical subject headings
- Amblyopia, Strabismus
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of the questionnaire
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880488
- Sponsor's protocol ID
- RBM_FAN_2013-7
- Acronym
- ASTEQ
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus
- ClinicalTrials.gov ID
- NCT02880488
- Acronym / sponsor ID
- ASTEQ / RBM_FAN_2013-7
- Conditions
- Amblyopia, Strabismus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Primary completion
- Jul 2015 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Outpatients of pediatric ophthalmology will be included in the study. 50 patients will be included in each class of age: 3-4 years old; 5-7 years old; 8-17 years old. For each class of age, 50 children with strabismus or amblyopa will be included, half of which treated by eye occlusion ; and 50 children with no strabismus nor amblyopia, half of which wearing glasses.
Key inclusion criteria (3 listed)
- children with a status of strabismus or not strabismus made by a specialized ophthalmologist
- children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist
- signed consent of parents
Key exclusion criteria (6 listed)
- ocular pathology (except for isolated ametropia)
- evolutive paralytic strabismus
- antecedent of surgery for strabismus
- strabismus surgery in the past 6 months
- disease with possible impact on the child's answers, such as severe neurologic troubles)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
validation of the questionnaire
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amblyopia and Strabismus, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation of the questionnaire (time frame: immediate). 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 26 Aug 2016.