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临床试验/NCT07530731
NCT07530731已完成不适用

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

Bulbitech1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
No statistical difference between acuracy of horizontal pro-saccades when comparing the three platforms

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Known alcoholic or drug dependency
  • Any condition that, in the investigator's judgment, would make the subject unsuitable for the study

研究组 & 干预措施

Ubuntu - Windows - NixOS

Experimental

order of tested platforms

干预措施: administration of 15 neuro-ophtalmological tests per platform by video-oculography (Device)

Windows - Ubuntu - NixOS

Experimental

order of tested platforms

干预措施: administration of 15 neuro-ophtalmological tests per platform by video-oculography (Device)

Windiws - NixOS - Ubuntu

Experimental

order of tested platforms

干预措施: administration of 15 neuro-ophtalmological tests per platform by video-oculography (Device)

NixOS - Ubuntu - Windows

Experimental

order of tested platforms

干预措施: administration of 15 neuro-ophtalmological tests per platform by video-oculography (Device)

NixOS - Windows - Ubuntu

Experimental

order of tested platforms

干预措施: administration of 15 neuro-ophtalmological tests per platform by video-oculography (Device)

Ubuntu-NixOS-Windows

Experimental

order of tested platforms

干预措施: administration of 15 neuro-ophtalmological tests per platform by video-oculography (Device)

结局指标

主要结局

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

时间窗: single visit at enrollment

unit: %

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

时间窗: Single visit at enrollment

unit: degree/s

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

时间窗: Single visit at enrollment

Unit: %

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

时间窗: Single visit at enrollment

unit: degree/s

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

时间窗: Single visit at enrollment

unit: Pelli-Robson

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

时间窗: Single visit at enrollment

unit: Pelli-Robson

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

时间窗: Single visit at enrollment

unit: Pelli-Robson

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

时间窗: Single visit at enrollment

no unit

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

时间窗: Single visit at enrollment

unit mm

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

时间窗: Single visit at enrollment

Unit: ms

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

时间窗: Single visit at enrollment

Unit: degree

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

时间窗: Single visit at enrollment

unit: degree/s

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: mm

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

时间窗: Single visit at enrollment

unit: degree

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

时间窗: Single visit at enrollment

unit: degree/s

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

时间窗: Single visit at enrollment

unit: %

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

时间窗: Single visit at enrollment

no unit

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: mm\*s

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

时间窗: Single visit at enrollment

unit: mm

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: mm/s

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: ms

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

时间窗: Single visit at enrollment

unit: %

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

时间窗: Single visit at enrollment

no unit

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

时间窗: Single visit at enrollment

unit: LogMAR

次要结局

  • 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)
  • No statistical difference between multidirectional pro-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration.(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.(Single visit at enrollment)
  • No statistical difference between anti-saccade latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration(Single visit at enrollment)
  • No statistical difference between memory saccades latencies when comparing Windows versus Ubuntu using the corrective formulas for timing calibration(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(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(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(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(Single visit at enrollment)
  • No statistical difference between smooth pursuit gain when comparing Windows versus NixOS using the corrective formulas for timing calibration(Single visit at enrollment)
  • No statistical difference between horizontal pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration(Single visit at enrollment)
  • No statistical difference between multidirectional pro-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration(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(Single visit at enrollment)
  • No statistical difference between anti-saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration(Single visit at enrollment)
  • No statistical difference between memory saccades latencies when comparing Windows versus NixOS using the corrective formulas for timing calibration(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(Single visit at enrollment)

研究者

发起方
Bulbitech
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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