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Completed

NCT Number: NCT07530731

Platforms Comparison Study - NIXOS-COMPARISON

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.

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Key information

Conditions

Healhty

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bulbitech

Trondheim, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

administration of 15 neuro-ophtalmological tests per platform by video-oculography

Device

List of the 15 tests per platform:

  • Calibration (functional screening)
  • Fixation test
  • Smooth pursuit
  • Horizontal pro-saccade
  • Multidirectional pro-saccade
  • Pursuit acuity
  • Pursuit contrast sensitivity
  • Strobe contrast sensitivity
  • Variable strobe
  • Pupil dynamics
  • RAPD
  • Visual Field 16-points
  • Ptosis
  • Anti saccade
  • Memory saccade

Primary outcomes

  1. No statistical difference between acuracy of horizontal pro-saccades when comparing the three platforms

    Time frame: single visit at enrollment

    unit: %

  2. No statistical difference between peak velocity of horizontal pro-saccades when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: degree/s

  3. No statistical difference between acuracy of multidirectional pro-saccades when comparing the three platforms

    Time frame: Single visit at enrollment

    Unit: %

  4. No statistical difference between peak velocity of multidirectional pro-saccades when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: degree/s

  5. No statistical difference between contrast sensitivity results when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: Pelli-Robson

  6. No statistical difference between variable strobe test results when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: Pelli-Robson

  7. No statistical difference between strobe contrast sensitivity results when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: Pelli-Robson

  8. No statistical difference between RAPD test result when comparing the three platforms

    Time frame: Single visit at enrollment

    no unit

  9. No statistical difference between ptosis MRD1 and 2 when comparing the three platforms

    Time frame: Single visit at enrollment

    unit mm

  10. No statistical difference between duration of fixation when comparing the three platforms

    Time frame: Single visit at enrollment

    Unit: ms

  11. No statistical difference between the amplitude of intrusive saccades when comparing the three platforms

    Time frame: Single visit at enrollment

    Unit: degree

  12. No statistical difference between the peak velocity of intrusive saccades when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: degree/s

  13. No statistical difference between the mean fixation time when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: ms

  14. No statistical difference between mean pupil size when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: mm

  15. No statistical difference between anti-saccade amplitudes when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: degree

  16. No statistical difference between anti-saccades peak velocity when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: degree/s

  17. No statistical difference between memory saccades accuracy when comparing the three platforms

    Time frame: Single visit at enrollment

    unit: %

  18. No statistical difference between number of errors in memory saccades task when comparing the three platforms

    Time frame: Single visit at enrollment

    no unit

  19. No statistical difference between memory saccades latencies when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: ms

  20. No statistical difference between anti saccades latencies when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: ms

  21. No statistical difference between saccadic reaction time in visual field test when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: ms

  22. No statistical difference between pupil area when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: mm*s

  23. No statistical difference between pupil diameters when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: mm

  24. No statistical difference between pupil contraction latencies when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: ms

  25. No statistical difference between peak velocity of pupil dilation when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: mm/s

  26. No statistical difference between multidirectional pro-saccade latencies when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: ms

  27. No statistical difference between horizontal pro-saccades latencies when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: ms

  28. No statistical difference between smooth pursuit gain when comparing Ubuntu and NixOS platforms

    Time frame: Single visit at enrollment

    unit: %

  29. No statistical difference between the calibration ratio when comparing the three platforms

    Time frame: Single visit at enrollment

    no unit

  30. No statistical difference between pursuit acuity results when comparing Windows versus NixOS platforms

    Time frame: Single visit at enrollment

    unit: LogMAR

Secondary outcomes

  1. No statistical difference between pupil areas when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration

    Time frame: 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

  2. No statistical difference between pupil diameters when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration

    Time frame: 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

  3. 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

    Time frame: 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

  4. No statistical difference between smooth pursuit gain when comparing Windows versus Ubuntu using the corrective formulas for timing calibration

    Time frame: Single visit at enrollment

    A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay.

    unit: %

  5. No statistical difference between horizontal pro-saccade latency when comparing Windows versus Ubuntu using the corrective formulas for timing calibration

    Time frame: 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

  6. No statistical difference between multidirectional pro-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration.

    Time frame: 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

  7. No statistical difference between saccadic reaction times in visual field test when comparing Windows versus Ubuntu using the corrective formulas for timing calibration.

    Time frame: 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

  8. No statistical difference between anti-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration

    Time frame: 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

  9. No statistical difference between memory saccades latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration

    Time frame: 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

  10. 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

    Time frame: 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

  11. No statistical difference between pupil area when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration

    Time frame: 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

  12. No statistical difference between pupil diameters when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and

    Time frame: 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

  13. 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

    Time frame: 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

  14. No statistical difference between smooth pursuit gain when comparing Windows versus NixOS using the corrective formulas for timing calibration

    Time frame: Single visit at enrollment

    A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. .

    Unit: %

  15. No statistical difference between horizontal pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration

    Time frame: 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

  16. No statistical difference between multidirectional pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration

    Time frame: 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

  17. No statistical difference between saccadic reaction time fo visual field test when comparing Windows versus NixOS using the corrective formulas for timing calibration

    Time frame: 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

  18. No statistical difference between anti-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration

    Time frame: 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

  19. No statistical difference between memory saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration

    Time frame: 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

  20. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bulbitech

Industry

Registry information

Official study title

Comparison of NixOS-based Neuro-Ophtalmic Testing Platform Versus Windows and Ubuntu-based Platforms

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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