Attention Deficit Disorder With Hyperactivity (ADHD)ADHDin15?NCT07136259
A Quick and Reliable Eye Movement Test to Help Diagnose ADHD in Children.
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD) and Attention Deficit Disorder (ADD), run by Onovis Augenpraxis at 1 site in Switzerland.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD)
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2025to 31 Jan 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of children aged 8 to 16 years. Two groups will be included: children with a clinically confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and age-matched children without ADHD. Participants will be recruited from pediatric and ophthalmologic clinics. Both male and female children are eligible. Informed consent will be obtained from participants and/or their legal guardians.
Who may be able to join
- For the ADHD group:
- Clinically confirmed diagnosis of ADHD by an expert (e.g., pediatrician, neuropsychologist, pediatric neurologist)
- Age between 8 and 16 years
- Written informed consent from the participant and/or legal guardian
- For the control group (non-ADHD):
- Age between 8 and 16 years
- No suspicion of ADHD
- Written informed consent from the participant and/or legal guardian
Who cannot join
- For both groups:
- Medical conditions known to affect ocular motor behavior (e.g., neurological or ophthalmological disorders)
- Doubts regarding the accuracy of the ADHD diagnosis (for the ADHD group)
- Lack of or questionable informed consent
- Suspicion of ADHD in control group participants (reported by parents, examiner, or physician)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
OnovisAugenpraxis
Bern, Canton of Bern, 3011
Beate Spychala, MSc., +41 78 677 84 18, beate.spychala@onovis.ch
About this study
Official title: Certified Comprehensive Eye-Movement Examination in Children With Attention Deficit Hyperactivity Disorder: An Objective, Reproducible and Quantitative Diagnosis in 15 Minutes?
Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Early and accurate diagnosis is crucial to ensure timely therapeutic and educational interventions. However, current diagnostic practices rely heavily on clinical interviews and behavioral observations, which are inherently subjective and resource-intensive.
There is a growing need for objective diagnostic tools that can complement or even partially replace current clinical assessments. One promising approach involves eye-tracking technology, as ADHD is associated with altered oculomotor control and attention-related neural circuits. These changes may be reflected in measurable eye movement parameters, including saccadic latency and fixation stability.
Read more
This clinical investigation uses a certified, CE-marked medical eye-tracking device (neos™) to assess whether specific eye movement parameters can serve as objective biomarkers for ADHD. Although the device was originally designed to assess visual pathway integrity, it also captures parameters related to attention and executive function through standardized protocols. The test is examiner-independent, non-invasive, and takes approximately 10 minutes.
The study is observational and non-interventional, involving two groups of participants aged 8 to 16: 50 children with a clinically confirmed diagnosis of ADHD and 50 age-matched non-ADHD controls. All participants will complete a single neos™ eye-tracking assessment.
The primary hypothesis is that children with ADHD will demonstrate greater variability in saccadic latency and a higher frequency of large saccades (> 3°) during fixation compared to controls. These differences will be analyzed as potential diagnostic biomarkers. Diagnostic accuracy will be evaluated using receiver operating characteristic (ROC) analysis, with sensitivity, specificity and area under the curve (AUC) values reported.
Secondary hypotheses include:
Oculomotor parameters derived from the neos™ system can distinguish between ADHD subtypes (predominantly inattentive, hyperactive-impulsive and combined).
Combined oculomotor metrics correlate with ADHD symptom severity, potentially enabling a quantitative assessment of disease burden.
The results of this study could pave the way for the clinical adoption of objective, scalable and rapid diagnostic tools for ADHD. Beyond clinical use, such tools may also be adapted for population screening, telemedicine or integration into consumer-grade technologies such as virtual reality headsets. By validating a market-approved device for a new mental health indication, this study represents a critical step toward bridging research and clinical application in ADHD diagnostics.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders in children and adolescents. It is estimated that over 5 % of young people worldwide are affected, with numbers rising in many countries. ADHD can cause serious difficulties in everyday life - at school, at home and in social settings. Children with ADHD often struggle with attention, impulsivity and hyperactivity. If not recognized and treated early, these challenges can persist into adolescence and adulthood, affecting academic success, social relationships and mental health.
A timely and accurate diagnosis is therefore essential. However, diagnosing ADHD is not straightforward. Currently, it relies mainly on interviews with parents and children, behavioral observations and standardized questionnaires. While these methods can be effective, they are also subjective. The process often depends on how clearly the symptoms are described, how experienced the clinician is and how much time is available for assessment. This can lead to uncertainty or delays in diagnosis, especially in borderline or complex cases.
To improve this situation, researchers are exploring new ways to make the diagnosis of ADHD more objective, faster and easier to reproduce. One promising tool is eye-tracking - a method that measures how a person's eyes move while they look at specific images or follow visual targets on a screen. Scientific studies have shown that people with ADHD tend to have different patterns of eye movement, especially when it comes to focus, reaction time, and maintaining attention.
In this study, we use a medically certified device called neos™, which is designed to record and analyze eye movements in a highly accurate and standardized way. The neos™ system is already approved for clinical use in Europe for examining the visual system, but in this investigation, it is being tested for a new purpose: supporting the diagnosis of ADHD. The test is short (about 10 minutes), non-invasive and does not require verbal responses or physical interaction. It is fully automated and can be performed in a clinic by non-specialist staff.
The study will include 100 children between the ages of 8 and 16. Half of the participants will have a prior, clinically confirmed diagnosis of ADHD made by a specialist (such as a pediatrician, child neurologist or neuropsychologist). The other half will be age-matched children without ADHD. All participants will complete the same neos™ eye-tracking assessment.
The main goal of the study is to find out whether specific eye movement parameters - especially the variability in how fast the eyes move (saccadic latency) and the number of small, rapid eye movements during fixation - can reliably distinguish between children with and without ADHD. The idea is that children with ADHD may show more irregularities or signs of reduced visual focus during the test. These measurable differences could serve as biomarkers, which are objective signs that help confirm a diagnosis.
In addition to the main analysis, the study will also look at whether these eye movement patterns can help:
to differentiate between the three subtypes of ADHD (inattentive, hyperactive-impulsive, and combined)
and estimate the severity of symptoms, potentially providing a new way to monitor treatment response over time.
Importantly, this is not a treatment study. The children will not receive medication or therapy. The study only involves a single, short eye-tracking test that is safe and well-tolerated.
If the results of the study are promising, the findings could help bring a new, objective tool into routine ADHD diagnostics. Because the neos™ device is already approved and available on the market, such a test could be implemented quickly in clinical settings. In the future, similar technology could even be adapted for screenings in schools, remote assessments via telemedicine or even self-monitoring with VR headsets, making ADHD diagnostics more accessible and scalable worldwide.
By making the diagnostic process more objective and less dependent on clinical interpretation alone, this study hopes to contribute to earlier and more accurate diagnoses-and ultimately better outcomes for children living with ADHD.
- Keywords
- ADHD, Eye Tracking, Oculomotor Function, Pupillary Response, Pedriatic Neuropsychiatry, Neurodevelopmental Disorders, Neurocognitive Testing, Non-invasive Assessment, Eye Movements
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | ADHD | |
| Group 2 | Control Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccade frequency during fixation
Number of saccades (eye movements > 3°) made during a fixation task. This frequency is hypothesized to be higher in children with ADHD than in controls.
Measured: Baseline
Variability of saccadic latency
Variability in the time it takes for participants to initiate saccadic eye movements in response to visual stimuli. This parameter is expected to be higher in children with ADHD compared to controls.
Measured: Baseline
Sensitivity and Specificity of Composite Oculomotor Biomarker for ADHD Diagnosis
Diagnostic sensitivity and specificity of a composite oculomotor biomarker derived from variables predictive of ADHD. Thresholds for individual parameters (e.g. saccadic latency variability > 110 ms, saccade frequency during fixation > 10/minute) will be based on literature and refined using internal study data prior to confirmatory analysis. Thresholds and analysis procedures will be pre-specified in the Statistical Analysis Plan.
Measured: At completion of baseline assessment (Day 0)
Secondary outcomes (2)
Discrimination Between ADHD Subtypes Using Multivariable Model Based on neos™ Eye-Tracking Parameters
A multivariable model based on neos™ eye-tracking parameters will be used to distinguish between the three ADHD subtypes: predominantly hyperactive-impulsive, predominantly inattentive and combined subtype. The model will incorporate all available neos™ eye-tracking data. Subtype classification performance (e.g. accuracy, sensitivity and specificity) will be evaluated based on internal validation procedures.
Measured: At the end of data collection and prior to final analysis (estimated Month 12)
Correlation of Disease Severity with Oculomotor Biomarker for ADHD Severity Assessment
Disease severity in ADHD will be assessed in relation to a combined analysis of ocular motor parameters obtained via neos™ eye-tracking. The goal is to establish a new quantitative biomarker for ADHD severity. The correlation between oculomotor metrics and standardized clinical severity ratings (e.g. ADHD symptom scales) will be evaluated.
Measured: Assessed at baseline visit (Day 0) - if everything is recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onovis Augenpraxis
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136259
- Sponsor's protocol ID
- 2025-D0052
- Acronym
- ADHDin15?
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wainstein G, Rojas-Libano D, Crossley NA, Carrasco X, Aboitiz F, Ossandon T. Pupil Size Tracks Attentional Performance In Attention-Deficit/Hyperactivity Disorder. Sci Rep. 2017 Aug 15;7(1):8228. doi: 10.1038/s41598-017-08246-w.
PubMed 28811624Schulz-Zhecheva Y, Voelkle MC, Beauducel A, Biscaldi M, Klein C. Intra-Subject Variability, Intelligence, and ADHD Traits in a Community-Based Sample. J Atten Disord. 2023 Jan;27(1):67-79. doi: 10.1177/10870547221118523. Epub 2022 Sep 8.
PubMed 36082454Salari N, Ghasemi H, Abdoli N, Rahmani A, Shiri MH, Hashemian AH, Akbari H, Mohammadi M. The global prevalence of ADHD in children and adolescents: a systematic review and meta-analysis. Ital J Pediatr. 2023 Apr 20;49(1):48. doi: 10.1186/s13052-023-01456-1.
PubMed 37081447Munoz DP, Broughton JR, Goldring JE, Armstrong IT. Age-related performance of human subjects on saccadic eye movement tasks. Exp Brain Res. 1998 Aug;121(4):391-400. doi: 10.1007/s002210050473.
PubMed 9746145Mostofsky SH, Lasker AG, Cutting LE, Denckla MB, Zee DS. Oculomotor abnormalities in attention deficit hyperactivity disorder: a preliminary study. Neurology. 2001 Aug 14;57(3):423-30. doi: 10.1212/wnl.57.3.423.
PubMed 11502907Maron DN, Bowe SJ, Spencer-Smith M, Mellahn OJ, Perrykkad K, Bellgrove MA, Johnson BP. Oculomotor deficits in attention deficit hyperactivity disorder (ADHD): A systematic review and comprehensive meta-analysis. Neurosci Biobehav Rev. 2021 Dec;131:1198-1213. doi: 10.1016/j.neubiorev.2021.10.012. Epub 2021 Oct 13.
PubMed 34655657Hamed AM, Kauer AJ, Stevens HE. Why the Diagnosis of Attention Deficit Hyperactivity Disorder Matters. Front Psychiatry. 2015 Nov 26;6:168. doi: 10.3389/fpsyt.2015.00168. eCollection 2015.
PubMed 26635643Constantino JN, Kennon-McGill S, Weichselbaum C, Marrus N, Haider A, Glowinski AL, Gillespie S, Klaiman C, Klin A, Jones W. Infant viewing of social scenes is under genetic control and is atypical in autism. Nature. 2017 Jul 20;547(7663):340-344. doi: 10.1038/nature22999. Epub 2017 Jul 12.
PubMed 28700580
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Certified Comprehensive Eye-Movement Examination in Children With Attention Deficit Hyperactivity Disorder: An Objective, Reproducible and Quantitative Diagnosis in 15 Minutes?
- ClinicalTrials.gov ID
- NCT07136259
- Acronym / sponsor ID
- ADHDin15? / 2025-D0052
- Keywords
- ADHD, Eye Tracking, Oculomotor Function, Pupillary Response, Pedriatic Neuropsychiatry, Neurodevelopmental Disorders, Neurocognitive Testing, Non-invasive Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Onovis AugenpraxisResearch network
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 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.
Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Early and accurate diagnosis is crucial to ensure timely therapeutic and educational interventions. However, current diagnostic practices rely heavily on clinical interviews and behavioral observations, which are inherently subjective and resource-intensive.
There is a growing need for objective diagnostic tools that can complement or even partially replace current clinical assessments. One promising approach involves eye-tracking technology, as ADHD is associated with altered oculomotor control and attention-related neural circuits. These changes may be reflected in measurable eye movement parameters, including saccadic latency and fixation stability.
This clinical investigation uses a certified, CE-marked medical eye-tracking device (neos™) to assess whether specific eye movement parameters can serve as objective biomarkers for ADHD. Although the device was originally designed to assess visual pathway integrity, it also captures parameters related to attention and executive function through standardized protocols. The test is examiner-independent, non-invasive, and takes approximately 10 minutes.
The study is observational and non-interventional, involving two groups of participants aged 8 to 16: 50 children with a clinically confirmed diagnosis of ADHD and 50 age-matched non-ADHD controls. All participants will complete a single neos™ eye-tracking assessment.
The primary hypothesis is that children with ADHD will demonstrate greater variability in saccadic latency and a higher frequency of large saccades (> 3°) during fixation compared to controls. These differences will be analyzed as potential diagnostic biomarkers. Diagnostic accuracy will be evaluated using receiver operating characteristic (ROC) analysis, with sensitivity, specificity and area under the curve (AUC) values reported.
Secondary hypotheses include:
Oculomotor parameters derived from the neos™ system can distinguish between ADHD subtypes (predominantly inattentive, hyperactive-impulsive and combined).
Combined oculomotor metrics correlate with ADHD symptom severity, potentially enabling a quantitative assessment of disease burden.
The results of this study could pave the way for the clinical adoption of objective, scalable and rapid diagnostic tools for ADHD. Beyond clinical use, such tools may also be adapted for population screening, telemedicine or integration into consumer-grade technologies such as virtual reality headsets. By validating a market-approved device for a new mental health indication, this study represents a critical step toward bridging research and clinical application in ADHD diagnostics.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders in children and adolescents. It is estimated that over 5 % of young people worldwide are affected, with numbers rising in many countries. ADHD can cause serious difficulties in everyday life - at school, at home and in social settings. Children with ADHD often struggle with attention, impulsivity and hyperactivity. If not recognized and treated early, these challenges can persist into adolescence and adulthood, affecting academic success, social relationships and mental health.
A timely and accurate diagnosis is therefore essential. However, diagnosing ADHD is not straightforward. Currently, it relies mainly on interviews with parents and children, behavioral observations and standardized questionnaires. While these methods can be effective, they are also subjective. The process often depends on how clearly the symptoms are described, how experienced the clinician is and how much time is available for assessment. This can lead to uncertainty or delays in diagnosis, especially in borderline or complex cases.
To improve this situation, researchers are exploring new ways to make the diagnosis of ADHD more objective, faster and easier to reproduce. One promising tool is eye-tracking - a method that measures how a person's eyes move while they look at specific images or follow visual targets on a screen. Scientific studies have shown that people with ADHD tend to have different patterns of eye movement, especially when it comes to focus, reaction time, and maintaining attention.
In this study, we use a medically certified device called neos™, which is designed to record and analyze eye movements in a highly accurate and standardized way. The neos™ system is already approved for clinical use in Europe for examining the visual system, but in this investigation, it is being tested for a new purpose: supporting the diagnosis of ADHD. The test is short (about 10 minutes), non-invasive and does not require verbal responses or physical interaction. It is fully automated and can be performed in a clinic by non-specialist staff.
The study will include 100 children between the ages of 8 and 16. Half of the participants will have a prior, clinically confirmed diagnosis of ADHD made by a specialist (such as a pediatrician, child neurologist or neuropsychologist). The other half will be age-matched children without ADHD. All participants will complete the same neos™ eye-tracking assessment.
The main goal of the study is to find out whether specific eye movement parameters - especially the variability in how fast the eyes move (saccadic latency) and the number of small, rapid eye movements during fixation - can reliably distinguish between children with and without ADHD. The idea is that children with ADHD may show more irregularities or signs of reduced visual focus during the test. These measurable differences could serve as biomarkers, which are objective signs that help confirm a diagnosis.
In addition to the main analysis, the study will also look at whether these eye movement patterns can help:
to differentiate between the three subtypes of ADHD (inattentive, hyperactive-impulsive, and combined)
and estimate the severity of symptoms, potentially providing a new way to monitor treatment response over time.
Importantly, this is not a treatment study. The children will not receive medication or therapy. The study only involves a single, short eye-tracking test that is safe and well-tolerated.
If the results of the study are promising, the findings could help bring a new, objective tool into routine ADHD diagnostics. Because the neos™ device is already approved and available on the market, such a test could be implemented quickly in clinical settings. In the future, similar technology could even be adapted for screenings in schools, remote assessments via telemedicine or even self-monitoring with VR headsets, making ADHD diagnostics more accessible and scalable worldwide.
By making the diagnostic process more objective and less dependent on clinical interpretation alone, this study hopes to contribute to earlier and more accurate diagnoses-and ultimately better outcomes for children living with ADHD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –ADHD |
| Group 2 | – | –Control Children |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of children aged 8 to 16 years. Two groups will be included: children with a clinically confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and age-matched children without ADHD. Participants will be recruited from pediatric and ophthalmologic clinics. Both male and female children are eligible. Informed consent will be obtained from participants and/or their legal guardians.
Key inclusion criteria (8 listed)
- Clinically confirmed diagnosis of ADHD by an expert (e.g., pediatrician, neuropsychologist, pediatric neurologist)
- Age between 8 and 16 years
- Written informed consent from the participant and/or legal guardian
- Age between 8 and 16 years
- No suspicion of ADHD
Key exclusion criteria (5 listed)
- Medical conditions known to affect ocular motor behavior (e.g., neurological or ophthalmological disorders)
- Doubts regarding the accuracy of the ADHD diagnosis (for the ADHD group)
- Lack of or questionable informed consent
- Suspicion of ADHD in control group participants (reported by parents, examiner, or physician)
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
Saccade frequency during fixation
Time frame: Baseline
Number of saccades (eye movements > 3°) made during a fixation task. This frequency is hypothesized to be higher in children with ADHD than in controls.
Variability of saccadic latency
Time frame: Baseline
Variability in the time it takes for participants to initiate saccadic eye movements in response to visual stimuli. This parameter is expected to be higher in children with ADHD compared to controls.
Sensitivity and Specificity of Composite Oculomotor Biomarker for ADHD Diagnosis
Time frame: At completion of baseline assessment (Day 0)
Diagnostic sensitivity and specificity of a composite oculomotor biomarker derived from variables predictive of ADHD. Thresholds for individual parameters (e.g. saccadic latency variability > 110 ms, saccade frequency during fixation > 10/minute) will be based on literature and refined using internal study data prior to confirmatory analysis. Thresholds and analysis procedures will be pre-specified in the Statistical Analysis Plan.
2 secondary outcomes
Discrimination Between ADHD Subtypes Using Multivariable Model Based on neos™ Eye-Tracking Parameters
Time frame: At the end of data collection and prior to final analysis (estimated Month 12)
Correlation of Disease Severity with Oculomotor Biomarker for ADHD Severity Assessment
Time frame: Assessed at baseline visit (Day 0) - if everything is recorded
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 22 Aug 2025.
- Background: PubMed 28811624Wainstein G, Rojas-Libano D, Crossley NA, Carrasco X, Aboitiz F, Ossandon T. Pupil Size Tracks Attentional Performance In Attention-Deficit/Hyperactivity Disorder. Sci Rep. 2017 Aug 15;7(1):8228. doi: 10.1038/s41598-017-08246-w.
- Background: PubMed 36082454Schulz-Zhecheva Y, Voelkle MC, Beauducel A, Biscaldi M, Klein C. Intra-Subject Variability, Intelligence, and ADHD Traits in a Community-Based Sample. J Atten Disord. 2023 Jan;27(1):67-79. doi: 10.1177/10870547221118523. Epub 2022 Sep 8.
- Background: PubMed 37081447Salari N, Ghasemi H, Abdoli N, Rahmani A, Shiri MH, Hashemian AH, Akbari H, Mohammadi M. The global prevalence of ADHD in children and adolescents: a systematic review and meta-analysis. Ital J Pediatr. 2023 Apr 20;49(1):48. doi: 10.1186/s13052-023-01456-1.
- Background: PubMed 9746145Munoz DP, Broughton JR, Goldring JE, Armstrong IT. Age-related performance of human subjects on saccadic eye movement tasks. Exp Brain Res. 1998 Aug;121(4):391-400. doi: 10.1007/s002210050473.
- Background: PubMed 11502907Mostofsky SH, Lasker AG, Cutting LE, Denckla MB, Zee DS. Oculomotor abnormalities in attention deficit hyperactivity disorder: a preliminary study. Neurology. 2001 Aug 14;57(3):423-30. doi: 10.1212/wnl.57.3.423.
- Background: PubMed 34655657Maron DN, Bowe SJ, Spencer-Smith M, Mellahn OJ, Perrykkad K, Bellgrove MA, Johnson BP. Oculomotor deficits in attention deficit hyperactivity disorder (ADHD): A systematic review and comprehensive meta-analysis. Neurosci Biobehav Rev. 2021 Dec;131:1198-1213. doi: 10.1016/j.neubiorev.2021.10.012. Epub 2021 Oct 13.
- Background: PubMed 26635643Hamed AM, Kauer AJ, Stevens HE. Why the Diagnosis of Attention Deficit Hyperactivity Disorder Matters. Front Psychiatry. 2015 Nov 26;6:168. doi: 10.3389/fpsyt.2015.00168. eCollection 2015.
- Background: PubMed 28700580Constantino JN, Kennon-McGill S, Weichselbaum C, Marrus N, Haider A, Glowinski AL, Gillespie S, Klaiman C, Klin A, Jones W. Infant viewing of social scenes is under genetic control and is atypical in autism. Nature. 2017 Jul 20;547(7663):340-344. doi: 10.1038/nature22999. Epub 2017 Jul 12.
- 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 Attention Deficit Disorder With Hyperactivity (ADHD) and Attention Deficit Disorder (ADD), run by Onovis Augenpraxis at 1 site in Switzerland.
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 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: opening soon, as of the sponsor's last update on 22 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 Switzerland. 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 Mathias Abegg, PD Dr. med. Dr. sc. nat. (+41 79 936 88 34, mathias.abegg@hin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saccade frequency during fixation (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT07136259, which also lists 8 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 22 Aug 2025.