AmblyopiaFALSSENCT07112560
Early Detection and Prevention of Amblyopia and Visual Impairment Through Systematic Pediatric Vision Screening
An observational study of Amblyopia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Amblyopia, characterized by reduced visual acuity, develops in childhood due to insufficient sensory stimulation of the affected eye. It is the leading cause of low vision and loss of stereoscopic vision in both children and adults. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- Standard screening procedure for amblyopia and New amblyopia screening method using a virtual reality headset.
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 3 to 7 years, including both amblyopic and non-amblyopic patients. All participants are recruited from the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg) or referred by their ophthalmologists.
Who may be able to join
- Patients aged 3 to 7 years at the time of consent signing.
- Patients followed in the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg).
- Holders of parental authority must be affiliated with or beneficiaries of the health insurance system.
- Holders of parental authority must be capable of understanding the objectives and risks related to the research, and able to provide dated and signed informed consent.
- Amblyopic patients must have amblyopia diagnosed by the reference screening method.
- Non-amblyopic patients must have undergone routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia.
- Screening must be performed in the Ophthalmology Department of CHU Strasbourg, unless a prior screening has been performed according to established guidelines and fully documented in a report by the patient's ophthalmologist (detailed results of the three standard screening tests).
- The screening examination must have been performed within the three months prior to the signing of the informed consent form.
Who cannot join
- Amblyopic children currently undergoing treatment or having previously received treatment for amblyopia (optical correction, strabismus surgery, occlusion therapy, orthoptic rehabilitation).
- Children presenting conditions or states that may cause side effects related to the use of the virtual reality headset (epilepsy, neurological or developmental disorders, autism spectrum disorders, dizziness, nausea, claustrophobia, etc.).
- Inability to provide informed information to the patient or holders of parental authority (emergency situations, difficulties in patient comprehension, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Nouvel Hôpital Civil
Strasbourg, 67091
Léa DORMEGNY, 0613325143 ext. +33, lea.dormegny@chru-strasbourg.fr
Lauriana SOLECKI, 0369550939 ext. +33, lauriana.solecki@chru-strasbourg.fr
About this study
Amblyopia, characterized by reduced visual acuity, develops in childhood due to insufficient sensory stimulation of the affected eye. It is the leading cause of low vision and loss of stereoscopic vision in both children and adults. Currently, 99 million people worldwide are affected, with recent projections indicating 222 million by 2040. Amblyopia can result from anisometropia (70%), strabismus (30%), or the presence of an ocular pathology (1%). Early management of these conditions (before the age of 7) can prevent the onset of amblyopia. Therefore, screening for these conditions is a major public health challenge to reduce the prevalence and associated costs of visual impairment.
The French-speaking Association of Strabology and Pediatric Ophthalmology (AFSOP) recommends systematic amblyopia screening for 3-year-old children. This screening involves measuring monocular visual acuity in both eyes (LEA chart at 3 meters), checking for strabismus (cover/uncover test), and performing a stereoscopic vision test (e.g., Lang I test).
Read more
Amblyopia is currently underdiagnosed for two main reasons: 1) it is often asymptomatic (75% of cases) and therefore cannot be detected without systematic screening; and 2) there is significant difficulty in accessing medical care in certain regions, and thus access to professionals capable of performing this screening (doctors, orthoptists). The difficulty in accessing healthcare professionals capable of screening for amblyopia in children aged 3 to 7 has already been raised.
We believe it would be beneficial to have an alternative screening method that is equivalent to the AFSOP-recommended method and accessible in areas with limited healthcare professionals. An eye-tracking system implemented in a virtual reality (VR) headset has recently been developed for monitoring eye movements. This system has shown effectiveness in rehabilitating visual field impairments in patients with traumatic brain injury. The system allows for remote monitoring of rehabilitation sessions, and data can be downloaded and viewed remotely via Wi-Fi.
The main objective of this study will be to estimate the sensitivity of the new VR-based eye-tracking screening method amblyopia screening method using an eye-tracking system implemented in a virtual reality headset compared to standard screening in children aged 3 to 7 years.
- Conditions
- Amblyopia
- Being tested
- Standard screening procedure for amblyopia, New amblyopia screening method using a virtual reality headset.
- Keywords
- Amblyopia, Visual impairment, New method for amblyopia screening, Pediatric amblyopia screening, Eye Tracking system
- Medical subject headings
- Amblyopia, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard screening procedure for amblyopiaDiagnostic test
The standard examination for amblyopia screening consists of three steps:
A monocular visual acuity assessment using optotypes from the LEA scale, presented from the simplest to the most complex in front of each eye via an alternating occlusion mask.
A cover/uncover test, during which the child is required to fixate on an image A Lang I stereopsis test performed under binocular vision.
New amblyopia screening method using a virtual reality headset.Diagnostic test
The examination with the virtual reality headset consists of three main steps: A monocular visual acuity assessment using optotypes from the LEA scale, presented from the simplest to the most complex in front of each eye via an alternating occlusion mask. The eye-tracking system analyzes fixation and the visual response of the stimulated eye. A cover/uncover test, during which the child is required to fixate on an image projected inside the headset. Eye movements are tracked to detect any deviations or abnormalities in ocular coordination. A Lang I stereopsis test performed under binocular vision, in which the child must identify three-dimensional images hidden within a virtual board. The eye-tracking system detects fixation on the images and allows evaluation of depth perception
| Study group | Role | What they receive |
|---|---|---|
| Amblyopic patient | Patient aged between 3 and 7 years, with amblyopia diagnosed by standard reference screening within the three months preceding the signing of the informed consent form. Receives: Diagnostic Test: Standard screening procedure for amblyopia; Diagnostic Test: New amblyopia screening method using a virtual reality headset. | |
| Non Amblyopic patient | Patient aged between 3 and 7 years, non-amblyopic, who underwent routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia, within the three months prior to signing the informed consent form. Receives: Diagnostic Test: Standard screening procedure for amblyopia; Diagnostic Test: New amblyopia screening method using a virtual reality headset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of a new amblyopia screening method compared to standard screening
Sensitivity of a new amblyopia screening method using an eye-tracking system implemented in a virtual reality headset, compared to standard screening, in children aged 3 to 7 years.
Sensitivity = (true positives) / (false negatives + true positives)
Measured: At enrollment.
Secondary outcomes (7)
Specificity of the eye-tracking system compared to standard screening
Specificity of the eye-tracking system implemented in a virtual reality headset, compared to standard screening in children aged 3 to 7 years.
Specificity = (true negatives) / (false positives + true negatives)
Measured: At enrollment.
Sensitivity and specificity of the eye-tracking system compared to the same tests performed during standard screening
These are respectively:
Monocular visual acuity of both eyes measured using the LEA symbol scale at 3 meters, presented via the virtual reality interface.
Presence or absence of a refixation movement during the cover/uncover test for strabismus screening.
Presence or absence of stereoscopic vision anomalies evaluated by projecting a Lang I test under binocular vision within the virtual reality headset.
Measured: At enrollment.
Cover/uncover test for strabismus screening : angle of deviation
The angle of deviation of movement of each eye (refixation movement) will be recorded using a cover/uncover test combined with monocular stimulation
Measured: At enrollment.
Proportion of adverse events recorded during the diagnostic process
The proportion of adverse events will be recorded by the investigator accompanying the child during the examination with the virtual reality system across all study groups. In particular, adverse events related to the use of the virtual reality headset will be documented (nausea, discomfort, photophobia, seizure).
Measured: Day of the diagnostic examination (Day 1)
Proportion of patients unable to complete the scheduled examination using the virtual reality headset
The proportion of patients unable to complete the scheduled examination using the virtual reality headset for any reason (including refusal to wear the headset, anxiety, or other factors) will be documented. This will include the number of patients for whom the examination could not be performed due to these reasons.
Measured: Day of the diagnostic examination (Day 1)
Cover/uncover test for strabismus screening : direction
The direction of movement of each eye will be recorded using a cover/uncover test combined with monocular stimulation
Measured: At enrollment
Cover/uncover test for strabismus screening : velocity
The velocity of movement of each eye (refixation movement) will be recorded using a cover/uncover test combined with monocular stimulation
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 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
- NCT07112560
- Sponsor's protocol ID
- 9746
- Acronym
- FALSSE
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Misawa M, Bajin IY, Zhang B, Daibert-Nido M, Tchao D, Garcia-Giler E, Cheung K, Appel L, Nasir P, Reginald A, Tabori U, Bartels U, Ramaswamy V, Markowitz SN, Bouffet E, Reber M. A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor: a single-arm feasibility and proof-of-concept trial. EClinicalMedicine. 2024 Nov 29;78:102955. doi: 10.1016/j.eclinm.2024.102955. eCollection 2024 Dec.
PubMed 39687429Daibert-Nido M, Pyatova Y, Cheung K, Nayomi C, Markowitz SN, Bouffet E, Reber M. Case Report: Visual Rehabilitation in Hemianopia Patients. Home-Based Visual Rehabilitation in Patients With Hemianopia Consecutive to Brain Tumor Treatment: Feasibility and Potential Effectiveness. Front Neurol. 2021 Jul 21;12:680211. doi: 10.3389/fneur.2021.680211. eCollection 2021.
PubMed 34354660Bois C, Milcent K, Dufourg M, Charles M. Bilan de santé des enfants de 3-4 ans en école maternelle par la Protection Maternelle Infantile en 2014-2016 : disparités départementales des pratiques. Bulletin Epidémiologique Hebdomadaire. Janvier 2020
Lequeux L, Thouvenin D, Couret C, Audren F, Costet C, Dureau P, Leruez S, Defoordt-Dhellemmes S, Daien V, Espinasse Berrod MA, Arsene S, Lebranchu P, Denis D, Bui-Quoc E, Speeg-Schatz C. [Vision screening for children: Recommended practices from AFSOP]. J Fr Ophtalmol. 2021 Feb;44(2):244-251. doi: 10.1016/j.jfo.2020.07.005. Epub 2020 Dec 30. French.
PubMed 33388188Kaur S, Sharda S, Aggarwal H, Dadeya S. Comprehensive review of amblyopia: Types and management. Indian J Ophthalmol. 2023 Jul;71(7):2677-2686. doi: 10.4103/IJO.IJO_338_23.
PubMed 37417105Fu Z, Hong H, Su Z, Lou B, Pan CW, Liu H. Global prevalence of amblyopia and disease burden projections through 2040: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1164-1170. doi: 10.1136/bjophthalmol-2019-314759. Epub 2019 Nov 8.
PubMed 31704700
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Prevention of Amblyopia and Visual Impairment Through Systematic Pediatric Vision Screening
- ClinicalTrials.gov ID
- NCT07112560
- Acronym / sponsor ID
- FALSSE / 9746
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Visual impairment, New method for amblyopia screening, Pediatric amblyopia screening, Eye Tracking system
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Aug 2025 (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.
Amblyopia, characterized by reduced visual acuity, develops in childhood due to insufficient sensory stimulation of the affected eye. It is the leading cause of low vision and loss of stereoscopic vision in both children and adults. Currently, 99 million people worldwide are affected, with recent projections indicating 222 million by 2040. Amblyopia can result from anisometropia (70%), strabismus (30%), or the presence of an ocular pathology (1%). Early management of these conditions (before the age of 7) can prevent the onset of amblyopia. Therefore, screening for these conditions is a major public health challenge to reduce the prevalence and associated costs of visual impairment.
The French-speaking Association of Strabology and Pediatric Ophthalmology (AFSOP) recommends systematic amblyopia screening for 3-year-old children. This screening involves measuring monocular visual acuity in both eyes (LEA chart at 3 meters), checking for strabismus (cover/uncover test), and performing a stereoscopic vision test (e.g., Lang I test).
Amblyopia is currently underdiagnosed for two main reasons: 1) it is often asymptomatic (75% of cases) and therefore cannot be detected without systematic screening; and 2) there is significant difficulty in accessing medical care in certain regions, and thus access to professionals capable of performing this screening (doctors, orthoptists). The difficulty in accessing healthcare professionals capable of screening for amblyopia in children aged 3 to 7 has already been raised.
We believe it would be beneficial to have an alternative screening method that is equivalent to the AFSOP-recommended method and accessible in areas with limited healthcare professionals. An eye-tracking system implemented in a virtual reality (VR) headset has recently been developed for monitoring eye movements. This system has shown effectiveness in rehabilitating visual field impairments in patients with traumatic brain injury. The system allows for remote monitoring of rehabilitation sessions, and data can be downloaded and viewed remotely via Wi-Fi.
The main objective of this study will be to estimate the sensitivity of the new VR-based eye-tracking screening method amblyopia screening method using an eye-tracking system implemented in a virtual reality headset compared to standard screening in children aged 3 to 7 years.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amblyopic patient | – | Diagnostic Test: Standard screening procedure for amblyopia, Diagnostic Test: New amblyopia screening method using a virtual reality headset.Patient aged between 3 and 7 years, with amblyopia diagnosed by standard reference screening within the three months preceding the signing of the informed consent form. |
| Non Amblyopic patient | – | Diagnostic Test: Standard screening procedure for amblyopia, Diagnostic Test: New amblyopia screening method using a virtual reality headset.Patient aged between 3 and 7 years, non-amblyopic, who underwent routine screening confirming the absence of amblyopia or any other ocular condition that could lead to amblyopia, within the three months prior to signing the informed consent form. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 3 to 7 years, including both amblyopic and non-amblyopic patients. All participants are recruited from the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg) or referred by their ophthalmologists.
Key inclusion criteria (8 listed)
- Patients aged 3 to 7 years at the time of consent signing.
- Patients followed in the Ophthalmology Department of Strasbourg University Hospital (CHU Strasbourg).
- Holders of parental authority must be affiliated with or beneficiaries of the health insurance system.
- Holders of parental authority must be capable of understanding the objectives and risks related to the research, and able to provide dated and signed informed consent.
- Amblyopic patients must have amblyopia diagnosed by the reference screening method.
Key exclusion criteria (3 listed)
- Amblyopic children currently undergoing treatment or having previously received treatment for amblyopia (optical correction, strabismus surgery, occlusion therapy, orthoptic rehabilitation).
- Children presenting conditions or states that may cause side effects related to the use of the virtual reality headset (epilepsy, neurological or developmental disorders, autism spectrum disorders, dizziness, nausea, claustrophobia, etc.).
- Inability to provide informed information to the patient or holders of parental authority (emergency situations, difficulties in patient comprehension, etc.).
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 |
|---|---|---|
| Standard screening procedure for amblyopiaThe standard examination for amblyopia screening consists of three steps: A monocular visual acuity assessment using optotypes from the LEA scale, presented from the simplest to the most complex in front of each eye via an alternating occlusion mask. A cover/uncover test, during which the child is required to fixate on an image A Lang I stereopsis test performed under binocular vision. | Diagnostic test | Amblyopic patient, Non Amblyopic patient |
| New amblyopia screening method using a virtual reality headset.The examination with the virtual reality headset consists of three main steps: A monocular visual acuity assessment using optotypes from the LEA scale, presented from the simplest to the most complex in front of each eye via an alternating occlusion mask. The eye-tracking system analyzes fixation and the visual response of the stimulated eye. A cover/uncover test, during which the child is required to fixate on an image projected inside the headset. Eye movements are tracked to detect any deviations or abnormalities in ocular coordination. A Lang I stereopsis test performed under binocular vision, in which the child must identify three-dimensional images hidden within a virtual board. The eye-tracking system detects fixation on the images and allows evaluation of depth perception | Diagnostic test | Amblyopic patient, Non Amblyopic patient |
Primary outcome
Sensitivity of a new amblyopia screening method compared to standard screening
Time frame: At enrollment.
Sensitivity of a new amblyopia screening method using an eye-tracking system implemented in a virtual reality headset, compared to standard screening, in children aged 3 to 7 years. Sensitivity = (true positives) / (false negatives + true positives)
7 secondary outcomes
Specificity of the eye-tracking system compared to standard screening
Time frame: At enrollment.
Sensitivity and specificity of the eye-tracking system compared to the same tests performed during standard screening
Time frame: At enrollment.
Cover/uncover test for strabismus screening : angle of deviation
Time frame: At enrollment.
Proportion of adverse events recorded during the diagnostic process
Time frame: Day of the diagnostic examination (Day 1)
Proportion of patients unable to complete the scheduled examination using the virtual reality headset
Time frame: Day of the diagnostic examination (Day 1)
Cover/uncover test for strabismus screening : direction
Time frame: At enrollment
Cover/uncover test for strabismus screening : velocity
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 39687429Misawa M, Bajin IY, Zhang B, Daibert-Nido M, Tchao D, Garcia-Giler E, Cheung K, Appel L, Nasir P, Reginald A, Tabori U, Bartels U, Ramaswamy V, Markowitz SN, Bouffet E, Reber M. A telerehabilitation program to improve visual perception in children and adolescents with hemianopia consecutive to a brain tumor: a single-arm feasibility and proof-of-concept trial. EClinicalMedicine. 2024 Nov 29;78:102955. doi: 10.1016/j.eclinm.2024.102955. eCollection 2024 Dec.
- Background: PubMed 34354660Daibert-Nido M, Pyatova Y, Cheung K, Nayomi C, Markowitz SN, Bouffet E, Reber M. Case Report: Visual Rehabilitation in Hemianopia Patients. Home-Based Visual Rehabilitation in Patients With Hemianopia Consecutive to Brain Tumor Treatment: Feasibility and Potential Effectiveness. Front Neurol. 2021 Jul 21;12:680211. doi: 10.3389/fneur.2021.680211. eCollection 2021.
- BackgroundBois C, Milcent K, Dufourg M, Charles M. Bilan de santé des enfants de 3-4 ans en école maternelle par la Protection Maternelle Infantile en 2014-2016 : disparités départementales des pratiques. Bulletin Epidémiologique Hebdomadaire. Janvier 2020
- Background: PubMed 33388188Lequeux L, Thouvenin D, Couret C, Audren F, Costet C, Dureau P, Leruez S, Defoordt-Dhellemmes S, Daien V, Espinasse Berrod MA, Arsene S, Lebranchu P, Denis D, Bui-Quoc E, Speeg-Schatz C. [Vision screening for children: Recommended practices from AFSOP]. J Fr Ophtalmol. 2021 Feb;44(2):244-251. doi: 10.1016/j.jfo.2020.07.005. Epub 2020 Dec 30. French.
- Background: PubMed 37417105Kaur S, Sharda S, Aggarwal H, Dadeya S. Comprehensive review of amblyopia: Types and management. Indian J Ophthalmol. 2023 Jul;71(7):2677-2686. doi: 10.4103/IJO.IJO_338_23.
- Background: PubMed 31704700Fu Z, Hong H, Su Z, Lou B, Pan CW, Liu H. Global prevalence of amblyopia and disease burden projections through 2040: a systematic review and meta-analysis. Br J Ophthalmol. 2020 Aug;104(8):1164-1170. doi: 10.1136/bjophthalmol-2019-314759. Epub 2019 Nov 8.
- 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.
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, 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 8 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: opening soon, as of the sponsor's last update on 8 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Léa DORMEGNY (0613325143 ext. +33, lea.dormegny@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of a new amblyopia screening method compared to standard screening (time frame: At enrollment.). 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 NCT07112560, which also lists 6 linked publications.
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 8 Aug 2025.