A Pilot Study to Assess the Efficacy and Safety of a Novel Device (VIZO Glasses) in the Management of ADHD in Adults
Phase: NA
Conditions: ADHD
Sponsor: VIZO Specs Ltd

Date: February 1st, 2022 
 
Study Protocol and Statistical Analysis Plan 
 
Study Title 
 
A Pilot Study to Assess the Efficacy and Safety of a Novel Device 
(VIZO Glasses) in the Management of ADHD in Adults 
Protocol ID 
VIZO_003 
ClinicalTrials.gov ID 
NCT05777785    
 

Protocol Synopsis 
VIZO_003 
 
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Device Name 
VIZO Glasses 
Objectives 
To Assess the Efficacy and Safety of a Novel Device (VIZO 
Glasses) in the Management of ADHD in Adults.  
 
Study Group 
Investigational Group 
VIZO Glasses:  Eyeglasses with personalized peripheral retinal 
stimuli 
 
Key Eligibility Criteria 
 
Inclusion Criteria 
• Documented history of primary ADHD diagnosis by 
certified clinicians 
• Age 18-40 y 
• Written informed consent 
• Able and willing to complete all required ratings and 
assessments 
Exclusion Criteria 
• Any current psychiatric / neurological comorbidity (e.g., 
epilepsy, Autism, depression, TBI, etc), other than ADHD 
• ADHD Medications (stimulants, non-stimulants, other) 
• Neurofeedback, cognitive training 
Endpoints 
 
Primary 
Adult ADHD Self-Report Scale (ASRS) - Total Score at Baseline 
and 2 Months Follow up 
The Adult ADHD Self-Report Scale (ASRS) is a self-report 
instrument that comprises eighteen items that correspond with 
the DSM-V-TR criteria for ADHD. Subjects are asked to rate 18 
symptom items using a 5-point Likert scale ranging from 0 
('Never') to 4 ('Very Often'). Total scores range from 0 to 72, 
based on the sum of all 18 questions. Higher scores mean more 
symptoms and higher ADHD's impairments. Lower values 
represent better outcomes. The ASRS has two subscales that 
can be used to identify ADHD subtypes - Inattentiveness and 
Hyperactivity/Impulsivity. Each subscale contains 9 questions. 
 
Adult ADHD Self-Report Scale (ASRS) - Inattentiveness Subscale 
Score at Baseline and 2 Months Follow up  
The inattentiveness sub-scale of the ASRS measures difficulties 
with focusing on details, organisation, remembering 
appointments, making careless mistakes, and concentration. It 
includes 9 symptom items using a 5-point Likert scale ranging 
from 0 ('Never') to 4 ('Very Often'). Total scores range from 0 to 
36, based on the sum of all questions. Higher scores mean more 
symptoms and higher inattentiveness' impairments. 

Protocol Synopsis 
VIZO_003 
 
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Secondary 
Clinical Global Impression-Improvement (CGI-I) - Rate 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. 
 
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. 
 
Behavior Rating Inventory of Executive Function Adult Version 
(BRIEF-A) - Metacognitive Index - at Baseline and 2 Months 
Follow up 
The Behavior Rating Inventory of Executive Function Adult 
Version (BRIEF-A) is a standardized measure that captures views 
of adults' executive functions or self-regulation in their 
everyday environment. The BRIEF-A comprises 75 items, each 
rated by the individual, using a 3-point Likert scale ranging from 
1 ('Never') to 3 ('Often'). BRIEF-A includes a Behavioral 
Regulation index, a Metacognition index, and a summary score-
Global Executive Composite. 
The Metacognition Index (MI) reflects the individual's ability to 
initiate activity and generate problem-solving ideas, to sustain 
working memory, to plan and organize problem-solving 
approaches, to monitor success and failure in problem solving, 
and to organize one's materials and environment. The MI 

Protocol Synopsis 
VIZO_003 
 
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subscale includes 40-items with score ranges between 40 to 
120. Higher values represent worse outcome and greater 
difficulties with executive functions. 
Other Outcomes 
Adverse events will be monitored and documented. 
Trial Design and Follow-up 
Visits Schedule 
This study was designed as a pilot single-center, open-label 
study of 2 months treatment. 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 Conners 
Continuous Performance Test-3, the Adult ADHD Self-Report 
Scale (ASRS), Behavior Rating Inventory of Executive Function 
Adults (BRIEF-A), and Clinical Global Impression-Improvement 
(CGI-I). 
Sample Size 
Power analyzes determined that a sample size of 90 
participants will have 80% power to detect an effect size of 0.30 
(Cohen’s D) using a paired t-test with a 0.05 two-sided 
significance level. Assuming a 20% attrition rate over the course 
of the study, 108 participants were targeted for inclusion. 
Analysis Plan 
Paired samples t-tests will be used to test the effect of the 
VIZO-glasses intervention, comparing the baseline and end-of-
intervention performances. No corrections for multiple testing 
will be applied due to the exploratory nature of the study. The 
safety analysis will include all available data on the intent-to-
treat (ITT) population. 
 
Paired samples t-tests will be used to test the effect of the 
VIZO-glasses intervention, comparing the baseline and end-of-
intervention performances. Normality distribution of data will 
be assessed using the Shapiro–Wilk test. Due to the exploratory 
nature of the study, no corrections for multiple testing will be 
applied. The safety analysis will include all available data on the 
intent-to-treat (ITT) population. Additionally, Mixed model 
ANOVA will was used to explore any potential effect of 
covariates such as gender, age, eyeglasses, learning disabilities, 
treatment naïve, and ASRS total score.