Platforms Comparison Study - NIXOS-COMPARISON

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healhty
• Intervention / Treatment: Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Bulbitech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ubuntu-NixOS-Windows; order of tested platforms	Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography; 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
Experimental: Ubuntu - Windows - NixOS; order of tested platforms	Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography; 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
Experimental: Windows - Ubuntu - NixOS; order of tested platforms	Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography; 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
Experimental: Windiws - NixOS - Ubuntu; order of tested platforms	Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography; 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
Experimental: NixOS - Ubuntu - Windows; order of tested platforms	Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography; 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
Experimental: NixOS - Windows - Ubuntu; order of tested platforms	Device: administration of 15 neuro-ophtalmological tests per platform by video-oculography; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No statistical difference between acuracy of horizontal pro-saccades when comparing the three platforms	unit: %	single visit at enrollment
No statistical difference between peak velocity of horizontal pro-saccades when comparing the three platforms	unit: degree/s	Single visit at enrollment
No statistical difference between acuracy of multidirectional pro-saccades when comparing the three platforms	Unit: %	Single visit at enrollment
No statistical difference between peak velocity of multidirectional pro-saccades when comparing the three platforms	unit: degree/s	Single visit at enrollment
No statistical difference between contrast sensitivity results when comparing the three platforms	unit: Pelli-Robson	Single visit at enrollment
No statistical difference between variable strobe test results when comparing the three platforms	unit: Pelli-Robson	Single visit at enrollment
No statistical difference between strobe contrast sensitivity results when comparing the three platforms	unit: Pelli-Robson	Single visit at enrollment
No statistical difference between RAPD test result when comparing the three platforms	no unit	Single visit at enrollment
No statistical difference between ptosis MRD1 and 2 when comparing the three platforms	unit mm	Single visit at enrollment
No statistical difference between duration of fixation when comparing the three platforms	Unit: ms	Single visit at enrollment
No statistical difference between the amplitude of intrusive saccades when comparing the three platforms	Unit: degree	Single visit at enrollment
No statistical difference between the peak velocity of intrusive saccades when comparing the three platforms	unit: degree/s	Single visit at enrollment
No statistical difference between the mean fixation time when comparing the three platforms	unit: ms	Single visit at enrollment
No statistical difference between mean pupil size when comparing the three platforms	unit: mm	Single visit at enrollment
No statistical difference between anti-saccade amplitudes when comparing the three platforms	unit: degree	Single visit at enrollment
No statistical difference between anti-saccades peak velocity when comparing the three platforms	unit: degree/s	Single visit at enrollment
No statistical difference between memory saccades accuracy when comparing the three platforms	unit: %	Single visit at enrollment
No statistical difference between number of errors in memory saccades task when comparing the three platforms	no unit	Single visit at enrollment
No statistical difference between memory saccades latencies when comparing Ubuntu and NixOS platforms	unit: ms	Single visit at enrollment
No statistical difference between anti saccades latencies when comparing Ubuntu and NixOS platforms	unit: ms	Single visit at enrollment
No statistical difference between saccadic reaction time in visual field test when comparing Ubuntu and NixOS platforms	unit: ms	Single visit at enrollment
No statistical difference between pupil area when comparing Ubuntu and NixOS platforms	unit: mm*s	Single visit at enrollment
No statistical difference between pupil diameters when comparing Ubuntu and NixOS platforms	unit: mm	Single visit at enrollment
No statistical difference between pupil contraction latencies when comparing Ubuntu and NixOS platforms	unit: ms	Single visit at enrollment
No statistical difference between peak velocity of pupil dilation when comparing Ubuntu and NixOS platforms	unit: mm/s	Single visit at enrollment
No statistical difference between multidirectional pro-saccade latencies when comparing Ubuntu and NixOS platforms	unit: ms	Single visit at enrollment
No statistical difference between horizontal pro-saccades latencies when comparing Ubuntu and NixOS platforms	unit: ms	Single visit at enrollment
No statistical difference between smooth pursuit gain when comparing Ubuntu and NixOS platforms	unit: %	Single visit at enrollment
No statistical difference between the calibration ratio when comparing the three platforms	no unit	Single visit at enrollment
No statistical difference between pursuit acuity results when comparing Windows versus NixOS platforms	unit: LogMAR	Single visit at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No statistical difference between pupil areas when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration	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	Single visit at enrollment
No statistical difference between pupil diameters when comparing Windows versus Ubuntu using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration	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	Single visit at enrollment
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	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	Single visit at enrollment
No statistical difference between smooth pursuit gain when comparing Windows versus Ubuntu using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: %	Single visit at enrollment
No statistical difference between horizontal pro-saccade latency when comparing Windows versus Ubuntu using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms	Single visit at enrollment
No statistical difference between multidirectional pro-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration.	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms	Single visit at enrollment
No statistical difference between saccadic reaction times in visual field test when comparing Windows versus Ubuntu using the corrective formulas for timing calibration.	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms	Single visit at enrollment
No statistical difference between anti-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms	Single visit at enrollment
No statistical difference between memory saccades latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms	Single visit at enrollment
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	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	Single visit at enrollment
No statistical difference between pupil area when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and timing calibration	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	Single visit at enrollment
No statistical difference between pupil diameters when comparing Windows versus NixOS using the corrective formulas for signal processing enhancement, modified stimulus and	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	Single visit at enrollment
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	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	Single visit at enrollment
No statistical difference between smooth pursuit gain when comparing Windows versus NixOS using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. . Unit: %	Single visit at enrollment
No statistical difference between horizontal pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms	Single visit at enrollment
No statistical difference between multidirectional pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms	Single visit at enrollment
No statistical difference between saccadic reaction time fo visual field test when comparing Windows versus NixOS using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. unit: ms	Single visit at enrollment
No statistical difference between anti-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms	Single visit at enrollment
No statistical difference between memory saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration	A timing calibration was implemented for Ubuntu and NixOS to improve accuracy results by accounting for the device delay. Unit: ms	Single visit at enrollment
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	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	Single visit at enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate the intraclass correlation coefficient for the maximum excursion of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the intraclass correlation coefficient for the excursion area of the motility range test on NixOS platform	unit: mm^2	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the intraclass correlation coefficient for the saccade latencies of the motility range test on NixOS platform	unit: ms	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the intraclass correlation coefficient for MDR1 and 2 of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the intraclass correlation coefficient for the peak velocity of the motility range test on NixOS platform	unit: mm/s	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the intraclass correlation coefficient for the scleral show of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the stability index for the excursion area of the motility range test on NixOS platform	unit: mm^2	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the stability index for the maximum excursion of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the stability index for the saccade latency of the motility range test on NixOS platform	unit: ms	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the stability index for the peak velocity of the motility range test on NixOS platform	unit: mm/s	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the stability index for MRD1 and 2 of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the stability index for the scleral show of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the agreement index for the excursion area of the motility range test on NixOS platform	unit: mm^2	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the agreement index for the maximum excursion of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the agreement index for the peak velocity of the motility range test on NixOS platform	unit: mm/s	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the agreement index for the saccade latency of the motility range test on NixOS platform	unit: ms	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the agreement index for MRD1 and 2 of the motility range test on NixOS platform	unti: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)
Calculate the agreement index for the scleral show of the motility range test on NixOS platform	unit: mm	Acquired at enrollment (Visit 1, V1) and at Visit 2 (within 2 weeks of V1)

Collaborators and Investigators

• Sponsor: Bulbitech

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): May 8, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: healthy control; video-oculography
• Other Study ID Numbers: NIXOS-COMPARISON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No