Healhty
Conditions
Keywords
video-oculography, healthy control
Brief summary
The purpose of the study is to verify that BulbiCAM®, a video-oculography medical device, gives similar results regardless of the Operating System (OS) used. The study compares three platforms: Windows, Linux Ubuntu, and Linux NixOS.
Interventions
DEVICEadministration of 15 neuro-ophtalmological tests per platform by video-oculography
List of the 15 tests per platform: 1. Calibration (functional screening) 2. Fixation test 3. Smooth pursuit 4. Horizontal pro-saccade 5. Multidirectional pro-saccade 6. Pursuit acuity 7. Pursuit contrast sensitivity 8. Strobe contrast sensitivity 9. Variable strobe 10. Pupil dynamics 11. RAPD 12. Visual Field 16-points 13. Ptosis 14. Anti saccade 15. Memory saccade
Sponsors
Bulbitech
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each subject will be tested on each of the three platform and serve as its own comparator.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult age 18-75 years inclusive * Willing and able to provide informed consent * Able to understand and follow instructions (Norwegian or English) * Able to complete testing procedures
Exclusion criteria
Ophthalmic: * Visual disturbance and blindness of any cause, except for corrected refractive errors * Visual acuity worse than 1.0 logMAR in the tested eye (unable to focus on test stimuli) * History of eye surgery in the last 6 months * Visible abnormalities of the eye (subconjunctival hemorrhages, inflammation, deformed pupils) * Significant eyelid ptosis that would interfere with testing * Pupils unable to respond normally to dilation/contraction due to nerve damage, mechanical damage, or medication Neurological/Medical: * Physical or psychiatric disease which may disturb the measuring procedure * Unable to tolerate testing or maintain attention for \~80 minutes with rest periods * Unable to understand and follow instructions * Photosensitive epilepsy Other: * Known alcoholic or drug dependency * Any condition that, in the investigator's judgment, would make the subject unsuitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No statistical difference between acuracy of horizontal pro-saccades when comparing the three platforms | single visit at enrollment | unit: % |
| No statistical difference between peak velocity of horizontal pro-saccades when comparing the three platforms | Single visit at enrollment | unit: degree/s |
| No statistical difference between acuracy of multidirectional pro-saccades when comparing the three platforms | Single visit at enrollment | Unit: % |
| No statistical difference between peak velocity of multidirectional pro-saccades when comparing the three platforms | Single visit at enrollment | unit: degree/s |
| No statistical difference between contrast sensitivity results when comparing the three platforms | Single visit at enrollment | unit: Pelli-Robson |
| No statistical difference between variable strobe test results when comparing the three platforms | Single visit at enrollment | unit: Pelli-Robson |
| No statistical difference between strobe contrast sensitivity results when comparing the three platforms | Single visit at enrollment | unit: Pelli-Robson |
| No statistical difference between RAPD test result when comparing the three platforms | Single visit at enrollment | no unit |
| No statistical difference between ptosis MRD1 and 2 when comparing the three platforms | Single visit at enrollment | unit mm |
| No statistical difference between duration of fixation when comparing the three platforms | Single visit at enrollment | Unit: ms |
| No statistical difference between the amplitude of intrusive saccades when comparing the three platforms | Single visit at enrollment | Unit: degree |
| No statistical difference between the peak velocity of intrusive saccades when comparing the three platforms | Single visit at enrollment | unit: degree/s |
| No statistical difference between the mean fixation time when comparing the three platforms | Single visit at enrollment | unit: ms |
| No statistical difference between mean pupil size when comparing the three platforms | Single visit at enrollment | unit: mm |
| No statistical difference between anti-saccade amplitudes when comparing the three platforms | Single visit at enrollment | unit: degree |
| No statistical difference between anti-saccades peak velocity when comparing the three platforms | Single visit at enrollment | unit: degree/s |
| No statistical difference between memory saccades accuracy when comparing the three platforms | Single visit at enrollment | unit: % |
| No statistical difference between number of errors in memory saccades task when comparing the three platforms | Single visit at enrollment | no unit |
| No statistical difference between memory saccades latencies when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: ms |
| No statistical difference between anti saccades latencies when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: ms |
| No statistical difference between saccadic reaction time in visual field test when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: ms |
| No statistical difference between pupil area when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: mm\*s |
| No statistical difference between pupil diameters when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: mm |
| No statistical difference between pupil contraction latencies when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: ms |
| No statistical difference between peak velocity of pupil dilation when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: mm/s |
| No statistical difference between multidirectional pro-saccade latencies when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: ms |
| No statistical difference between horizontal pro-saccades latencies when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: ms |
| No statistical difference between smooth pursuit gain when comparing Ubuntu and NixOS platforms | Single visit at enrollment | unit: % |
| No statistical difference between the calibration ratio when comparing the three platforms | Single visit at enrollment | no unit |
| No statistical difference between pursuit acuity results when comparing Windows versus NixOS platforms | Single visit at enrollment | unit: LogMAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No statistical difference between pupil areas when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: mm\*s |
| No statistical difference between pupil diameters when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: mm |
| No statistical difference between latency of pupil contraction when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms |
| No statistical difference between smooth pursuit gain when comparing Windows versus Ubuntu using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: % |
| No statistical difference between horizontal pro-saccade latency when comparing Windows versus Ubuntu using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between multidirectional pro-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration. | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between saccadic reaction times in visual field test when comparing Windows versus Ubuntu using the corrective formulas for timing calibration. | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between anti-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms |
| No statistical difference between memory saccades latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms |
| No statistical difference between peak velocity of pupil dilation when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement and modified stimulus | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows. Unit: mm/s |
| No statistical difference between pupil area when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: mm\*s |
| No statistical difference between pupil diameters when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: mm |
| No statistical difference between latencies of pupil contraction when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between smooth pursuit gain when comparing Windows versus NixOS using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. . Unit: % |
| No statistical difference between horizontal pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between multidirectional pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms |
| No statistical difference between saccadic reaction time fo visual field test when comparing Windows versus NixOS using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms |
| No statistical difference between anti-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between memory saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration | Single visit at enrollment | A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms |
| No statistical difference between peak velocity of the pupil when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement and modified stimulus | Single visit at enrollment | Ubuntu and NixOS platforms contain an enhanced algorithm incorporating Fourier transform analysis of pupil data. The light used as a stimulus for the pupil dynamics test has been modified (in intensity, wavelength, and spatial characteristics) under Ubuntu/NixOS platform compared to the original stimulus under Windows Unit: mm/s |
Countries
Norway
Outcome results
None listed