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Repeatability and diurnal variation of eye responses measured with Neuro-Ophthalmic Device (NODe)

Intra-participant repeatability and diurnal variation of eye movements and pupil size response using the Neuro-Ophthalmic Device (NODe) in healthy population

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000371594
Enrollment
20
Registered
2015-04-23
Start date
2015-05-04
Completion date
2015-10-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Percy Lazon de la Jara
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026