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This is a 2-month study in which eligible ADHD adolescents will be provided with personalized VIZO Glasses
This is a pilot, open-label study of a 2-month treatment with VIZO Glasses. Following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of VIZO Glasses. The participants will be instructed to wear the glasses throughout the day for two months. A follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of VIZO Glasses on managing ADHD symptoms, using the ADHD Rating Scale (ADHD-RS) parent-report questionnaire, the Behavior Rating Inventory of Executive Function (BRIEF), the Conners Continuous Performance Test-3, and the Clinical Global Impression-Improvement (CGI-I). Safety will be monitored by documentation of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | VIZO Glasses- personalized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIZO Glasses | Device | Eyeglasses with personalized peripheral retinal stimuli |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up | The ADHD-RS is a parent report questionnaire that is used to aid in the diagnosis of ADHD in children ranging from ages 5-17. The questionnaire contains 18 symptom items corresponding to the DSM-V criteria for ADHD. The parent rates each symptom item on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 54. Higher scores mean more symptoms and higher ADHD impairments. | Baseline, 2-month |
| Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up | The Inattention subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's attention level on tasks or play activities.The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments. | Baseline, 2-month |
| Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up | The Hyperactivity-Impulsivity subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's hyperactivity level and impulsivity level. The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments. | Baseline, 2-month |
| Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up | The Metacognition Index (MI) of the BRIEF reflects a child's ability to self-manage and monitor tasks cognitively. The subscale is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales of the BRIEF. It uses a Likert-type response format ranging from 1 to 3, where 1 is never, 2 is sometimes, and 3 is often. The MI subscale includes 40-items with score ranges between 0 to 120. Higher values represent worse outcome and greater difficulties with executive functions. High scores indicate executive deficit. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up | Based on an interview with the participant, the clinician rates the total improvement on a 7 point scale as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zohar Elyoseph, PhD | Max Stern Academic College of Emek Yezreel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Max Stern Academic College of Emek Yezreel | Haifa | Israel |
Thirty-two participants met the inclusion criteria. Three participants failed to complete the personalization process, resulting in 29 participants receiving the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | VIZO Glasses- personalized VIZO Glasses: Eyeglasses with personalized peripheral retinal stimuli |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant excluded from per-protocol analysis due to a major protocol deviation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | VIZO Glasses- personalized VIZO Glasses: Eyeglasses with personalized peripheral retinal stimuli |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score - at Baseline and 2 Months Follow up | The ADHD-RS is a parent report questionnaire that is used to aid in the diagnosis of ADHD in children ranging from ages 5-17. The questionnaire contains 18 symptom items corresponding to the DSM-V criteria for ADHD. The parent rates each symptom item on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 54. Higher scores mean more symptoms and higher ADHD impairments. | Three participants did not complete the questionnaire. | Posted | Mean | Standard Error | score on a scale | Baseline, 2-month |
|
Adverse event data was collected during the two-month intervention period.
No serious adverse events were reported, and no events led to intervention discontinuation. All side effects were transient, reported to be mild or moderate, and resolved after the removal of the glasses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | VIZO Glasses- personalized VIZO Glasses: Eyeglasses with personalized peripheral retinal stimuli |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yael Richter, PhD | VIZO Specs | 972-54-7384809 | yaelr@vizo-o.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2022 | Mar 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Baseline, 2-month |
| 2-month |
| Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up | The BRIEF is a standardized measure that captures views of executive functions or self-regulation in the everyday environment. The BRIEF is composed of 86 items, where each item is rated by the parent, using a 3-point Likert scale ranging from 1 ('Never') to 3 ('Often'). Total score ranges between 86 to 258. The Global Executive Composite (GEC) is an overarching summary score that incorporates all of the BRIEF clinical scales. High scores indicate executive deficit. | Baseline, 2-month |
| Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up | Conners' Continuous Performance Test-3 (CPT-3) is an objective test of attention and impulsivity that has been validated in individuals aged 8 years and older. d-prime (d') is a measure of how well the respondent discriminates nontargets (i.e., the letter X) from targets (i.e., all other letters). This variable is also a signal detection statistic that measures the difference between the signal (targets) and noise (non-targets) distributions. In general, the greater the difference between the signal and noise distributions, the better the ability to distinguish non-targets and targets. CPT scores are age and gender standardized T-scores, in which the mean is equal to 50 and the standard deviation is equal to 10. d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). Atypical scores are higher than 60 indicating "elevated" to "very elevated" performance. | Baseline, 2 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Total Score | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Inattentiveness Subscale - at Baseline and 2 Months Follow up | The Inattention subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's attention level on tasks or play activities.The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments. | Three participants did not complete the questionnaire. | Posted | Mean | Standard Error | score on a scale | Baseline, 2-month |
|
|
|
|
| Primary | Change in the ADHD Rating Scale (ADHD-RS) Parent-report Questionnaire - Hyperactivity-Impulsivity Subscale - at Baseline and 2 Months Follow up | The Hyperactivity-Impulsivity subscale of the ADHD-RS contains 9 symptom items, that are designed to measure the child's hyperactivity level and impulsivity level. The items are rated by the parent on a 4-point Likert scale ranging from 0 ('Never or Rarely') to 3 ('Very Often'). The total score goes from 0 up to 27. Higher scores mean more symptoms and higher ADHD impairments. | Three participants did not complete the questionnaire. | Posted | Mean | Standard Error | score on a scale | Baseline, 2-month |
|
|
|
|
| Primary | Change in Behavior Rating Inventory of Executive Function (BRIEF) - Metacognitive Index - at Baseline and 2 Months Follow up | The Metacognition Index (MI) of the BRIEF reflects a child's ability to self-manage and monitor tasks cognitively. The subscale is composed of the Initiate, Working Memory, Plan/Organize, Organization of Materials, and Monitor scales of the BRIEF. It uses a Likert-type response format ranging from 1 to 3, where 1 is never, 2 is sometimes, and 3 is often. The MI subscale includes 40-items with score ranges between 0 to 120. Higher values represent worse outcome and greater difficulties with executive functions. High scores indicate executive deficit. | Four participants did not complete the questionnaire. | Posted | Mean | Standard Error | score on a scale | Baseline, 2-month |
|
|
|
|
| Secondary | Clinical Global Impression-Improvement (CGI-I) - at 2 Months Follow up | Based on an interview with the participant, the clinician rates the total improvement on a 7 point scale as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. | One participant did not participate in the clinicial interview. | Posted | Count of Participants | Participants | 2-month |
|
|
|
| Secondary | Change in Behavior Rating Inventory of Executive Function (BRIEF) - Global Executive Composite - at Baseline and 2 Months Follow up | The BRIEF is a standardized measure that captures views of executive functions or self-regulation in the everyday environment. The BRIEF is composed of 86 items, where each item is rated by the parent, using a 3-point Likert scale ranging from 1 ('Never') to 3 ('Often'). Total score ranges between 86 to 258. The Global Executive Composite (GEC) is an overarching summary score that incorporates all of the BRIEF clinical scales. High scores indicate executive deficit. | Four participants did not complete the questionnaire. | Posted | Mean | Standard Error | score on a scale | Baseline, 2-month |
|
|
|
|
| Secondary | Change in Conners' Continuous Performance Test-3 (CPT-3) - Detectability (d') at Baseline and 2 Months Follow up | Conners' Continuous Performance Test-3 (CPT-3) is an objective test of attention and impulsivity that has been validated in individuals aged 8 years and older. d-prime (d') is a measure of how well the respondent discriminates nontargets (i.e., the letter X) from targets (i.e., all other letters). This variable is also a signal detection statistic that measures the difference between the signal (targets) and noise (non-targets) distributions. In general, the greater the difference between the signal and noise distributions, the better the ability to distinguish non-targets and targets. CPT scores are age and gender standardized T-scores, in which the mean is equal to 50 and the standard deviation is equal to 10. d' is reverse-scored so that higher raw score and T-score values indicate worse performance (i.e., poorer discrimination). Atypical scores are higher than 60 indicating "elevated" to "very elevated" performance. | One participant did not complete the test. | Posted | Mean | Standard Error | T-score | Baseline, 2 months |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 15 |
| 24 |
| Eyestrain | General disorders | Non-systematic Assessment |
|
| Discomfort | General disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Tiredness | General disorders | Non-systematic Assessment |
|
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