NCT07530731

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

March 25, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

video-oculographyhealthy control

Outcome Measures

Primary Outcomes (30)

  • 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 Outcomes (20)

  • 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

  • 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

  • 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

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

    Single visit at enrollment

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

    Single visit at enrollment

  • +15 more secondary outcomes

Study Arms (6)

Ubuntu-NixOS-Windows

EXPERIMENTAL

order of tested platforms

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

Ubuntu - Windows - NixOS

EXPERIMENTAL

order of tested platforms

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

Windows - Ubuntu - NixOS

EXPERIMENTAL

order of tested platforms

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

Windiws - NixOS - Ubuntu

EXPERIMENTAL

order of tested platforms

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

NixOS - Ubuntu - Windows

EXPERIMENTAL

order of tested platforms

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

NixOS - Windows - Ubuntu

EXPERIMENTAL

order of tested platforms

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

Interventions

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

NixOS - Ubuntu - WindowsNixOS - Windows - UbuntuUbuntu - Windows - NixOSUbuntu-NixOS-WindowsWindiws - NixOS - UbuntuWindows - Ubuntu - NixOS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulbitech

Trondheim, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Each subject will be tested on each of the three platform and serve as its own comparator.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 15, 2026

Study Start

April 1, 2026

Primary Completion

May 8, 2026

Study Completion

May 8, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations