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Trial registered on ANZCTR


Registration number
ACTRN12615000371594
Ethics application status
Not yet submitted
Date submitted
9/02/2015
Date registered
23/04/2015
Date last updated
29/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Repeatability and diurnal variation of eye responses measured with Neuro-Ophthalmic Device (NODe)
Scientific title
Intra-participant repeatability and diurnal variation of eye movements and pupil size response using the Neuro-Ophthalmic Device (NODe) in healthy population
Secondary ID [1] 286119 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild traumatic brain injury (mTBI) or concussion 294120 0
medically diagnosed psychiatric disorder 294121 0
epilepsy or any type of seizure 294122 0
Condition category
Condition code
Injuries and Accidents 294437 294437 0 0
Other injuries and accidents
Mental Health 294438 294438 0 0
Schizophrenia
Neurological 294526 294526 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The NODe is a pre-release, prototype table top imaging device that consists of visual stimulus presentations through a standard tablet (iPAD like) and imaging hardware mounted inside of an enclosure which includes a nose-bridge and a chin-rest for patient alignment. The device intends to test neuro-pathology such as mild traumatic brain injury (mTBI or concussion) by assessing eye movements and pupil reactions in response to different visual stimuli presented on the tablet screen.
The NODe has several features, including a very high frame capture rate that permit acquisition of highly-detailed data on direction of eye gaze and pupil diameter. The operator will instruct the participant on how the NODe exam will occur, including what to expect from the visual stimuli and how long the exam should take. Each test consists of a series of targets that the subject must follow with their gaze or a series of light flashes that will be presented while the participant focuses on a static target.
The study will be conducted in two phases with each phase including 10 participants. The initial visit will include the participant performing the NODe tests repeatedly for 10 times, while the remaining 6 visits (2 visits per day) will test diurnal variation and will run NODe set of tests once in each visit. The initial visit may take up to 2 hours, while the remaining 6 visits will take up to 15 minutes each to complete. The visits need not necessarily be on consecutive days, but will be conducted within the time period of a fortnight.
Intervention code [1] 291191 0
Early detection / Screening
Intervention code [2] 291192 0
Diagnosis / Prognosis
Comparator / control treatment
It is a study to test repeatability and diurnal variation between measurements using the NODe. Therefore, there is no active control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294235 0
Collection of a full set of NODe data including:
- pupil diameter (mm), pupil constriction velocity (deg/sec) and latency (msec), pupil dilatation velocity (deg/sec) and latency (msec), and duration (sec);
- saccadic amplitude (mm), accuracy (mean), velocity (deg/sec), latency (msec), number of damping saccades;
- relative pupillary response differences; and
- relative saccadic response differences.
Timepoint [1] 294235 0
Ten times in the first visit and once at each of the remaining 6 visits.
Secondary outcome [1] 312858 0
Subjective fatigue / anxiety ratings using a questionnaire designed specifically for this study.
Timepoint [1] 312858 0
Prior to data collecting with NODe, at each of the 6 visits in each study phase.
Secondary outcome [2] 313005 0
Subjective fatigue / anxiety ratings using a questionnaire designed specifically for this study.
Timepoint [2] 313005 0
Following data collecting with NODe, ten times in the first visit and once each at the remaining 6 visits.

Eligibility
Key inclusion criteria
- 18 to 60 years of age
- Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- medically diagnosed psychiatric disorder, with or without current medication
- history of significant head trauma or concussion or any known neurological problem
- medically diagnosed epilepsy or history of seizure
- In the medical examiner’s opinion, be intoxicated (alcohol or drugs) or have had more than 2 standard alcoholic drinks in the 4 hours prior to study visit
- Have undertaken any recreational drugs in the last 48 hours

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
none
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
Sample size calculation: Approximately 10 participants are required within each phase in order to demonstrate a statistically significant difference between repeat days and between time points of at least 1x the within-subject standard deviation of each NODe eye response variable at the 5% level of significance and 90% power. The sample size is not adjusted for dropout rate. The sample size is determined non-statistically based on an empirical approximation of the number of participants necessary to draw conclusions about the data. These conclusions, including inter- and intra-subject variability, will be used to inform future study sample sizes.
Data analysis: NODe derived pupil response and eye movements measurements will be recorded on a numeric continuous scale. Data will be summarised as means +/- standard deviations. Log or square root transformation may be required prior to data analysis. The pupil response and eye movement variables will be compared between repeat days and repeat visits within a day using, e.g. repeated measures ANOVA or Linear mixed model with repeated effects. Interactions will be tested and, if present, the significance will be determined within each visit / day using, e.g. paired t-test or repeated measures ANOVA based on the number of levels.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290706 0
Commercial sector/Industry
Name [1] 290706 0
Brien Holden Vision Diagnostics Inc.
Address [1] 290706 0
437, Miller Valley Road, Suite A, Prescott, AZ 86301
Country [1] 290706 0
United States of America
Primary sponsor type
Individual
Name
Percy Lazon de la Jara
Address
Brien Holden Vision Institute, Level 5,
Rupert Myers Building, North Wing,
University of New South Wales,
Gate 14, Barker Street, Kensington,
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 289398 0
None
Name [1] 289398 0
N/A
Address [1] 289398 0
N/A
Country [1] 289398 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292341 0
Bellberry Human Research Ethics
Ethics committee address [1] 292341 0
Bellberry Limited. 229 Greenhill Road, Dulwich, South Australia, 5065
Ethics committee country [1] 292341 0
Australia
Date submitted for ethics approval [1] 292341 0
29/04/2015
Approval date [1] 292341 0
Ethics approval number [1] 292341 0

Summary
Brief summary
This is a study designed to determine intra-participant repeatability and diurnal variation of various eye reflexes using a Neuro-Ophthalmic Device (NODe). The NODe is a pre-release, prototype table top imaging device that consists of visual stimulus presentations through a standard tablet (iPAD like) and imaging hardware mounted inside of an enclosure which includes a nose-bridge and a chin-rest for patient alignment. The device intends to test neuro -pathology such as mild traumatic brain injury (mTBI or concussion) by assessing eye movements and pupil reactions in response to different visual stimuli presented on the tablet screen.
The aim of this investigation is to determine the repeatability of this device in healthy participants with no previous history of concussion and diurnal variation of eye movements and pupil reaction.
The study will be conducted in two phases with each phase including 10 participants. The initial visit will include the participant performing the NODe tests repeatedly for 10 times, while the remaining 6 visits (2 visits per day) will test diurnal variation and will run NODe set of tests once in each visit. The initial visit may take up to 2 hours, while the remaining 6 visits will take up to 15 minutes each to complete.
The instrument has not yet been released commercially, but does not contain any components that could potentially cause eye or other injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54714 0
Mr Daniel Tilia
Address 54714 0
Brien Holden Vision Institute, Level 4,
Rupert Myers building, North Wing,
Gate 14, UNSW, Barker Street,
Kensington, Sydney NSW 2052
Country 54714 0
Australia
Phone 54714 0
+61 2 9385 6165
Fax 54714 0
+61 2 9385 7401
Email 54714 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 54715 0
Prof Eric Papas
Address 54715 0
Brien Holden Vision Institute, Level 4,
Rupert Myers building, North Wing,
Gate 14, UNSW, Barker Street,
Kensington, Sydney NSW 2052
Country 54715 0
Australia
Phone 54715 0
+61 2 9385 7489
Fax 54715 0
+61 2 9385 7401
Email 54715 0
e.papas@brienholdenvision.org
Contact person for scientific queries
Name 54716 0
Prof Eric Papas
Address 54716 0
Brien Holden Vision Institute, Level 4,
Rupert Myers building, North Wing,
Gate 14, UNSW, Barker Street,
Kensington, Sydney NSW 2052
Country 54716 0
Australia
Phone 54716 0
+61 2 9385 7489
Fax 54716 0
+61 2 9385 7401
Email 54716 0
e.papas@brienholdenvision.org

No information has been provided regarding IPD availability
Summary results
No Results