Visual Impairment in ChildrenORTHOPHTALMONCT04395560
Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4
An observational study of Visual Impairment in Children, run by Clinique Rive Gauche at 1 site in France.
Trial summary
Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual… Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Visual Impairment in Children
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2020to 28 Jun 2021
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Children from 3 to 4 years old, girls or boys, with a medical reason for consultation (paediatric orientation) or parent's request (child's complaint)
Who may be able to join
- Children from 3 to 4 years old consulting for a screening of visual disorders,
- Patients registered with French social security scheme,
- Not participating in any other clinical study,
- Consent obtained from one of the two parents or the legal representative.
Who cannot join
- Children whose parent or legal representative is vulnerable according to article L1121-6 of the CSP,
- Children whose parent or legal guardian is under guardianship or trusteeship or under legal protection,
- Children, whose parent or legal guardian is unable to give consent, or is protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual impairment.
The screening protocol for this study recommends that a screening examination for amblyopia and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4 year old. This examination should include, as a minimum, a standardised measurement of visual acuity, a cover test and a measurement of refraction by photoscreener. In the event of a positive screening, the child must then be referred to an ophthalmologist so as to complete an ophthalmological examination.
Read more
The aim of this protocol is to propose screening tests usually performed with a high specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding excessive or unnecessary referral of children to the ophthalmologist) without losing sensitivity by combining several tests.
The orthoptists' role in this screening protocol is to facilitate an extensive screening coverage of the population in this age group, as they are more easily accessed by the patients and more equitably spread in the community than ophthalmologists.
Therefore, by initially screening and then referring less children to the ophthalmologist, the aim is to reduce waiting times in the access of ophthalmological services which could be detrimental in terms of treatment success rates for patients acutely needing care.
Based on the referral of children between 3 and 4 years of age by the orthoptist to an ophthalmologist, the analysis of the data from the standard screening protocol used in our centre will enable us to validate it scientifically. The referral thresholds can thus be secondarily adjusted for each test if the initial objectives are not achieved (specificity > 90% and sensitivity > 87%). The aim of this study is also to observe a change in the patient flow by reducing the volume of consultations with the ophthalmologist currently required based on the present referral rate. The efficiency of the screening protocol by calculating the probable economic gain linked to the modification of the screening circuit will be secondarily studying in this protocol
- Conditions
- Visual Impairment in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
The need to refer the child to an ophthalmologist (YES/NO)
the addressing requirements is evaluated by the orthoptist and ophthalmologist based on the patient's chart and clinical examinations
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Score of parental satisfaction (algorithmically calculate)
Assessed by the Likert scale (satisfaction questionnaire)
Measured: through study completion, an average of 1 year
The number of ophthalmologic consultations saved
Evaluated according to the tariffs of the different nomenclatures of the acts
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start4 Oct 2020
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Impairment in ChildrenStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Rive Gauche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Dr Thouvenin, Principal investigator, Ophtalmologie Rive Gauche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395560
- Sponsor's protocol ID
- 01/2020
- Other IDs
- 2020-A00262-37
- Acronym
- ORTHOPHTALMO
- Status last verified
- Jul 2021
- First submitted
- 13 May 2020
- Last updated
- 12 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lequeux L, Bonifas C, Alby A, Bontron C, Brovelli C, Huygens J, Norbert O, Pey C, Martinez L, Thouvenin Md D. Evaluation of the diagnostic parameters of the amblyopia and risk factors for amblyopia screening protocol in 3-year-olds according to recommendations from the French Association for Pediatric Ophthalmology and Strabismus (AFSOP) compared with reference ophthalmological examination: the ORTHOPHTALMO study. Strabismus. 2025 Jun;33(2):93-103. doi: 10.1080/09273972.2024.2422418. Epub 2024 Nov 6.
PubMed 39506219
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4
- ClinicalTrials.gov ID
- NCT04395560
- Acronym / sponsor ID
- ORTHOPHTALMO / 01/2020
- Conditions
- Visual Impairment in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Clinique Rive GaucheUniversity, hospital or other
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 20 May 2020 (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 developmental abnormalities affect 10 to 15% of the population under 6 years of age and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood has consequences on the quality of life of individuals but will also represent a cost to society due to the increased risk of visual impairment.
The screening protocol for this study recommends that a screening examination for amblyopia and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4 year old. This examination should include, as a minimum, a standardised measurement of visual acuity, a cover test and a measurement of refraction by photoscreener. In the event of a positive screening, the child must then be referred to an ophthalmologist so as to complete an ophthalmological examination.
The aim of this protocol is to propose screening tests usually performed with a high specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding excessive or unnecessary referral of children to the ophthalmologist) without losing sensitivity by combining several tests.
The orthoptists' role in this screening protocol is to facilitate an extensive screening coverage of the population in this age group, as they are more easily accessed by the patients and more equitably spread in the community than ophthalmologists.
Therefore, by initially screening and then referring less children to the ophthalmologist, the aim is to reduce waiting times in the access of ophthalmological services which could be detrimental in terms of treatment success rates for patients acutely needing care.
Based on the referral of children between 3 and 4 years of age by the orthoptist to an ophthalmologist, the analysis of the data from the standard screening protocol used in our centre will enable us to validate it scientifically. The referral thresholds can thus be secondarily adjusted for each test if the initial objectives are not achieved (specificity > 90% and sensitivity > 87%). The aim of this study is also to observe a change in the patient flow by reducing the volume of consultations with the ophthalmologist currently required based on the present referral rate. The efficiency of the screening protocol by calculating the probable economic gain linked to the modification of the screening circuit will be secondarily studying in this protocol
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 3 to 4 years old, girls or boys, with a medical reason for consultation (paediatric orientation) or parent's request (child's complaint)
Key inclusion criteria (4 listed)
- Children from 3 to 4 years old consulting for a screening of visual disorders,
- Patients registered with French social security scheme,
- Not participating in any other clinical study,
- Consent obtained from one of the two parents or the legal representative.
Key exclusion criteria (3 listed)
- Children whose parent or legal representative is vulnerable according to article L1121-6 of the CSP,
- Children whose parent or legal guardian is under guardianship or trusteeship or under legal protection,
- Children, whose parent or legal guardian is unable to give consent, or is protected by law.
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
The need to refer the child to an ophthalmologist (YES/NO)
Time frame: through study completion, an average of 1 year
the addressing requirements is evaluated by the orthoptist and ophthalmologist based on the patient's chart and clinical examinations
2 secondary outcomes
Score of parental satisfaction (algorithmically calculate)
Time frame: through study completion, an average of 1 year
The number of ophthalmologic consultations saved
Time frame: through study completion, an average of 1 year
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 12 Jul 2021.
- Derived from this study: PubMed 39506219Lequeux L, Bonifas C, Alby A, Bontron C, Brovelli C, Huygens J, Norbert O, Pey C, Martinez L, Thouvenin Md D. Evaluation of the diagnostic parameters of the amblyopia and risk factors for amblyopia screening protocol in 3-year-olds according to recommendations from the French Association for Pediatric Ophthalmology and Strabismus (AFSOP) compared with reference ophthalmological examination: the ORTHOPHTALMO study. Strabismus. 2025 Jun;33(2):93-103. doi: 10.1080/09273972.2024.2422418. Epub 2024 Nov 6.
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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.
Dominique Dr Thouvenin principal investigator
Ophtalmologie Rive Gauche
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 Visual Impairment in Children, run by Clinique Rive Gauche 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 3 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 12 Jul 2021. 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?
The need to refer the child to an ophthalmologist (YES/NO) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04395560, which also lists 1 linked publication.
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 12 Jul 2021.