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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05971238
Other study ID # MPI-TSCN-2023-NATURALEYE
Secondary ID 2023-231-S-KH
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date July 31, 2024

Study information

Verified date July 2023
Source Technical University of Munich
Contact Alexander Hahn
Phone +49(0)70716011670
Email alexander.hahn@tuebingen.mpg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the researchers will be using eye tracking and detailed lighting measurements to understand how different types of indoor and outdoor lighting affect the eye movements and pupil sizes of our participants. Participants will be paired up and undergo six eye tracking sessions, split across two appointments. Each appointment will involve viewing either indoor or outdoor scenes, and before each session, participants will spend time adapting to the lighting conditions. Overall, each participant will spend 24 minutes being tracked, and the entire study will take about 2-3 hours to complete. The investigators expect differences in eye movements and pupil size between indoor and outdoor scenes.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date July 31, 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - No previous eye-surgeries or ocular impairments like anisometropia, amblyopia, strabism, cataract, watery eyes or hanging eye lids - Normal or corrected-to-normal visual acuity (+3dpt. to -5dpt.) - Normal colour vision - Normal binocular vision Exclusion Criteria: - Any use of medications or drugs that influence photosensitivity or the ability to concentrate - Excessive alcohol and/or drug use - Presence of psychiatric disorders - Poor sleep quality - Diagnosed with epilepsy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Indoor vs. outdoor scenes
Light conditions in indoor (artificial light) and outdoor (daylight) settings

Locations

Country Name City State
Germany Max Planck Institute for Biological Cybernetics Tübingen

Sponsors (2)

Lead Sponsor Collaborator
Technical University of Munich Max-Planck Institute for Biological Cybernetics

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Saccade frequency - Indoor scene 1 Number per second [n/s] Baseline
Primary Saccade frequency - Indoor scene 2 Number per second [n/s] Baseline
Primary Saccade frequency - Indoor scene 3 Number per second [n/s] Baseline
Primary Saccade frequency - Outdoor scene 1 Number per second [n/s] Baseline
Primary Saccade frequency - Outdoor scene 2 Number per second [n/s] Baseline
Primary Saccade frequency - Outdoor scene 3 Number per second [n/s] Baseline
Primary Saccade amplitude - Indoor scene 1 Mean angular distance traveled [°] Baseline
Primary Saccade amplitude - Indoor scene 2 Mean angular distance traveled [°] Baseline
Primary Saccade amplitude - Indoor scene 3 Mean angular distance traveled [°] Baseline
Primary Saccade amplitude - Outdoor scene 1 Mean angular distance traveled [°] Baseline
Primary Saccade amplitude - Outdoor scene 2 Mean angular distance traveled [°] Baseline
Primary Saccade amplitude - Outdoor scene 3 Mean angular distance traveled [°] Baseline
Primary Saccade velocity - Indoor scene 1 Mean peak velocity [°/s] Baseline
Primary Saccade velocity - Indoor scene 2 Mean peak velocity [°/s] Baseline
Primary Saccade velocity - Indoor scene 3 Mean peak velocity [°/s] Baseline
Primary Saccade velocity - Outdoor scene 1 Mean peak velocity [°/s] Baseline
Primary Saccade velocity - Outdoor scene 2 Mean peak velocity [°/s] Baseline
Primary Saccade velocity - Outdoor scene 3 Mean peak velocity [°/s] Baseline
Primary Fixation duration - Indoor scene 1 Mean fixation duration [s] Baseline
Primary Fixation duration - Indoor scene 2 Mean fixation duration [s] Baseline
Primary Fixation duration - Indoor scene 3 Mean fixation duration [s] Baseline
Primary Fixation duration - Outdoor scene 1 Mean fixation duration [s] Baseline
Primary Fixation duration - Outdoor scene 2 Mean fixation duration [s] Baseline
Primary Fixation duration - Outdoor scene 3 Mean fixation duration [s] Baseline
Primary Fixation frequency - Indoor scene 1 Number per minute [n/min] Baseline
Primary Fixation frequency - Indoor scene 2 Number per minute [n/min] Baseline
Primary Fixation frequency - Indoor scene 3 Number per minute [n/min] Baseline
Primary Fixation frequency - Outdoor scene 1 Number per minute [n/min] Baseline
Primary Fixation frequency - Outdoor scene 2 Number per minute [n/min] Baseline
Primary Fixation frequency - Outdoor scene 3 Number per minute [n/min] Baseline
Primary Pupil size - Indoor scene 1 Mean pupil size [mm] Baseline
Primary Pupil size - Indoor scene 2 Mean pupil size [mm] Baseline
Primary Pupil size - Indoor scene 3 Mean pupil size [mm] Baseline
Primary Pupil size - Outdoor scene 1 Mean pupil size [mm] Baseline
Primary Pupil size - Outdoor scene 2 Mean pupil size [mm] Baseline
Primary Pupil size - Outdoor scene 3 Mean pupil size [mm] Baseline
Primary Melanopic irradiance - Indoor scene 1 Irradiance [W/(sqm*nm)] Baseline
Primary Melanopic irradiance - Indoor scene 2 Irradiance [W/(sqm*nm)] Baseline
Primary Melanopic irradiance - Indoor scene 3 Irradiance [W/(sqm*nm)] Baseline
Primary Melanopic irradiance - Outdoor scene 1 Irradiance [W/(sqm*nm)] Baseline
Primary Melanopic irradiance - Outdoor scene 2 Irradiance [W/(sqm*nm)] Baseline
Primary Melanopic irradiance - Outdoor scene 3 Irradiance [W/(sqm*nm)] Baseline
Primary Photopic illuminance - Indoor scene 1 Illuminance [lux] Baseline
Primary Photopic illuminance - Indoor scene 2 Illuminance [lux] Baseline
Primary Photopic illuminance - Indoor scene 3 Illuminance [lux] Baseline
Primary Photopic illuminance - Outdoor scene 1 Illuminance [lux] Baseline
Primary Photopic illuminance - Outdoor scene 2 Illuminance [lux] Baseline
Primary Photopic illuminance - Outdoor scene 3 Illuminance [lux] Baseline
Secondary Subjective scene ratings - Indoor scene 1 Unabbreviated scale titles (1)., min. and max, values (2.), score assessment (3.):
1. "How beautiful is this scene to you?" 2. "1 = not beautiful at all; 10 = extremely beautiful" 3. No better or worse outcome
1. "How would you rate the brightness of this scene?" 2. "1 = dimly lit room; 10 = bright sunny day" 3. No better or worse outcome
1. "How visually comfortable did you find this scene?" 2. "1 = No discomfort; 10 = Very uncomfortable" 3. No better or worse outcome
1. "How would you rate the complexity of the scene (e.g. colour contrasts, different object identities, moving objects)?" 2. "1 = very simple; 10 = Very complex" 3. No better or worse outcome
1. "How sleepy do you currently feel" 2. "1 = Extremely alert; 10 = Extremely sleep, can't keep awake" 3. Lower score is better
Baseline
Secondary Subjective scene ratings - Indoor scene 2 Unabbreviated scale titles (1)., min. and max, values (2.), score assessment (3.):
1. "How beautiful is this scene to you?" 2. "1 = not beautiful at all; 10 = extremely beautiful" 3. No better or worse outcome
1. "How would you rate the brightness of this scene?" 2. "1 = dimly lit room; 10 = bright sunny day" 3. No better or worse outcome
1. "How visually comfortable did you find this scene?" 2. "1 = No discomfort; 10 = Very uncomfortable" 3. No better or worse outcome
1. "How would you rate the complexity of the scene (e.g. colour contrasts, different object identities, moving objects)?" 2. "1 = very simple; 10 = Very complex" 3. No better or worse outcome
1. "How sleepy do you currently feel" 2. "1 = Extremely alert; 10 = Extremely sleep, can't keep awake" 3. Lower score is better
Baseline
Secondary Subjective scene ratings - Indoor scene 3 Unabbreviated scale titles (1)., min. and max, values (2.), score assessment (3.):
1. "How beautiful is this scene to you?" 2. "1 = not beautiful at all; 10 = extremely beautiful" 3. No better or worse outcome
1. "How would you rate the brightness of this scene?" 2. "1 = dimly lit room; 10 = bright sunny day" 3. No better or worse outcome
1. "How visually comfortable did you find this scene?" 2. "1 = No discomfort; 10 = Very uncomfortable" 3. No better or worse outcome
1. "How would you rate the complexity of the scene (e.g. colour contrasts, different object identities, moving objects)?" 2. "1 = very simple; 10 = Very complex" 3. No better or worse outcome
1. "How sleepy do you currently feel" 2. "1 = Extremely alert; 10 = Extremely sleep, can't keep awake" 3. Lower score is better
Baseline
Secondary Subjective scene ratings - Outdoor scene 1 Unabbreviated scale titles (1)., min. and max, values (2.), score assessment (3.):
1. "How beautiful is this scene to you?" 2. "1 = not beautiful at all; 10 = extremely beautiful" 3. No better or worse outcome
1. "How would you rate the brightness of this scene?" 2. "1 = dimly lit room; 10 = bright sunny day" 3. No better or worse outcome
1. "How visually comfortable did you find this scene?" 2. "1 = No discomfort; 10 = Very uncomfortable" 3. No better or worse outcome
1. "How would you rate the complexity of the scene (e.g. colour contrasts, different object identities, moving objects)?" 2. "1 = very simple; 10 = Very complex" 3. No better or worse outcome
1. "How sleepy do you currently feel" 2. "1 = Extremely alert; 10 = Extremely sleep, can't keep awake" 3. Lower score is better
Baseline
Secondary Subjective scene ratings - Outdoor scene 2 Unabbreviated scale titles (1)., min. and max, values (2.), score assessment (3.):
1. "How beautiful is this scene to you?" 2. "1 = not beautiful at all; 10 = extremely beautiful" 3. No better or worse outcome
1. "How would you rate the brightness of this scene?" 2. "1 = dimly lit room; 10 = bright sunny day" 3. No better or worse outcome
1. "How visually comfortable did you find this scene?" 2. "1 = No discomfort; 10 = Very uncomfortable" 3. No better or worse outcome
1. "How would you rate the complexity of the scene (e.g. colour contrasts, different object identities, moving objects)?" 2. "1 = very simple; 10 = Very complex" 3. No better or worse outcome
1. "How sleepy do you currently feel" 2. "1 = Extremely alert; 10 = Extremely sleep, can't keep awake" 3. Lower score is better
Baseline
Secondary Subjective scene ratings - Outdoor scene 3 Unabbreviated scale titles (1)., min. and max, values (2.), score assessment (3.):
1. "How beautiful is this scene to you?" 2. "1 = not beautiful at all; 10 = extremely beautiful" 3. No better or worse outcome
1. "How would you rate the brightness of this scene?" 2. "1 = dimly lit room; 10 = bright sunny day" 3. No better or worse outcome
1. "How visually comfortable did you find this scene?" 2. "1 = No discomfort; 10 = Very uncomfortable" 3. No better or worse outcome
1. "How would you rate the complexity of the scene (e.g. colour contrasts, different object identities, moving objects)?" 2. "1 = very simple; 10 = Very complex" 3. No better or worse outcome
1. "How sleepy do you currently feel" 2. "1 = Extremely alert; 10 = Extremely sleep, can't keep awake" 3. Lower score is better
Baseline
Secondary Geographical scene location - Indoor scene 1 Longitude and latitude [°] Baseline
Secondary Geographical scene location - Indoor scene 2 Longitude and latitude [°] Baseline
Secondary Geographical scene location - Indoor scene 3 Longitude and latitude [°] Baseline
Secondary Geographical scene location - Outdoor scene 1 Longitude and latitude [°] Baseline
Secondary Geographical scene location - Outdoor scene 2 Longitude and latitude [°] Baseline
Secondary Geographical scene location - Outdoor scene 3 Longitude and latitude [°] Baseline
Secondary Ambient temperature - Indoor scene 1 Temperature [°C] Baseline
Secondary Ambient temperature - Indoor scene 2 Temperature [°C] Baseline
Secondary Ambient temperature - Indoor scene 3 Temperature [°C] Baseline
Secondary Ambient temperature - Outdoor scene 1 Temperature [°C] Baseline
Secondary Ambient temperature - Outdoor scene 2 Temperature [°C] Baseline
Secondary Ambient temperature - Outdoor scene 3 Temperature [°C] Baseline
See also
  Status Clinical Trial Phase
Terminated NCT04251234 - Light at Night Study N/A
Completed NCT01860534 - "Eye Protection After Mydriatic Use for ROP Screening: Impact on Vitals Signs and Pain Scores" N/A