AmblyopiaVISIONNCT05204069
Screening for 3-D Visual Disorders in Preschool Children
A study testing Instillation of cyclopentolate in people with Amblyopia and Strabismus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Strabismus, Anisometropia
- What is being tested?
- Instillation of cyclopentolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Sep 2021
- Phase
- Interventional
- 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 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3 to 4 years
- Enrolled in kindergarten in the first section
- In the 19th district of Paris
- Who should benefit from visual screening via the school medical service
Who cannot join
- Children who do not speak French
- Children who are physically or cognitively unable to participate in the screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for 3-D Visual Disorders in Preschool Children, VISION Study
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation.
Read the detailed description
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Methodology: The "Association Française de Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions visual screening to assess whether or not a child presents risk factors of amblyopia such as ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume that a vision screening operated with the AFSOP 3 dimension screening recommendations and conducted by paramedical actors such as orthoptists will prove more sensitive and easier to implement on a national scale.
- Conditions
- Amblyopia, Strabismus, Anisometropia
- Being tested
- Instillation of cyclopentolate
- Medical subject headings
- Amblyopia, Strabismus, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instillation of cyclopentolateDrug
Instillation of cyclopentolate of 3 drops of cyclopentolate at t0',t5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device.
| Study group | Role | What they receive |
|---|---|---|
| Three-dimensional screening for visual disorders using the RetinoMax Device | Experimental | Instillation of cyclopentolate of 3 drops of cyclopentolate at T0',T5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device. Receives: Drug: Instillation of cyclopentolate |
| Non-standardized device for usual vision disorders | Active comparator | Screening device for usual vision disorders, performed by the school doctor during the usual prevention visit, with the tools used in the school doctor's current practice, non-standardized, according to his preference Receives: Drug: Instillation of cyclopentolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening for 3-dimensional visual disorders
Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel BUI-QUOC, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204069
- Sponsor's protocol ID
- APHP201100
- Other IDs
- 2019-A03128-49
- Acronym
- VISION
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for 3-D Visual Disorders in Preschool Children, VISION Study
- ClinicalTrials.gov ID
- NCT05204069
- Acronym / sponsor ID
- VISION / APHP201100
- Conditions
- Amblyopia, Strabismus, Anisometropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Jan 2022 (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.
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation.
Detailed description
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Methodology: The "Association Française de Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions visual screening to assess whether or not a child presents risk factors of amblyopia such as ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume that a vision screening operated with the AFSOP 3 dimension screening recommendations and conducted by paramedical actors such as orthoptists will prove more sensitive and easier to implement on a national scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-dimensional screening for visual disorders using the RetinoMax Device | Experimental | Drug: Instillation of cyclopentolateInstillation of cyclopentolate of 3 drops of cyclopentolate at T0',T5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device. |
| Non-standardized device for usual vision disorders | Active comparator | Drug: Instillation of cyclopentolateScreening device for usual vision disorders, performed by the school doctor during the usual prevention visit, with the tools used in the school doctor's current practice, non-standardized, according to his preference |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3 to 4 years
- Enrolled in kindergarten in the first section
- In the 19th district of Paris
- Who should benefit from visual screening via the school medical service
Key exclusion criteria (2 listed)
- Children who do not speak French
- Children who are physically or cognitively unable to participate in the screening
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 |
|---|---|---|
| Instillation of cyclopentolateInstillation of cyclopentolate of 3 drops of cyclopentolate at t0',t5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device. | Drug | Non-standardized device for usual vision disorders, Three-dimensional screening for visual disorders using the RetinoMax Device |
Primary outcome
Screening for 3-dimensional visual disorders
Time frame: 1 day
Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard
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 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Emmanuel BUI-QUOC, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instillation of cyclopentolate in people with Amblyopia and Strabismus, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 2 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 24 Jan 2022. 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?
Screening for 3-dimensional visual disorders (time frame: 1 day). 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 24 Jan 2022.