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The Effect of Varying Brightness on Palpebral Aperture

Primary Purpose

Eyelid Ptoses

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Review of eyelid positioning in increasing brightness levels
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Eyelid Ptoses focused on measuring Palpebral Aperture measurements

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged between 18 and 65 years of age
  • A member of the Royal Free NHS trust

Exclusion Criteria:

  • No known ocular pathology
  • No lid problems/ptosis or previous lid surgery
  • No contact lenses in for duration of experiment
  • No pseudophakia
  • No neurological disease

Sites / Locations

  • Ophthalmology, Royal Free Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The observation of eyelid positioning and EEG pulses from the eyelid on increasing brightness

Arm Description

In a dimly lit room the participant will place their chin on the slit lamp We will use t he optimal background illumination used for Humphrey and Goldman visual fields which is 31.5 apostilbs (10Lux 9 They will look into the video camera placed 50cm away, which will have a dimmable remote control ring light fitted around it. The part icipant will have a reference measure taped to the headrest and three electrodes placed around the right eye. One active electrode place on the lower lid and one reference electrode towards the temporal margin and one earth electrode placed on the forehead The brightness of the ring light will be increased via the dimmer switch whilst simultaneously recording the lux with the LED light meter. The participant will be advised t o close their eyes if the brightness becomes uncomfortable and this will be repea ted three times.

Outcomes

Primary Outcome Measures

The point at which the eyelid begins to contract under what brightness level
Using a light meter, ring light, and EEG machine

Secondary Outcome Measures

Full Information

First Posted
January 14, 2022
Last Updated
January 14, 2022
Sponsor
University of Edinburgh
Collaborators
National Health Service, United Kingdom, Royal Free Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05210491
Brief Title
The Effect of Varying Brightness on Palpebral Aperture
Official Title
The Effect of Varying Brightness Levels on Palpebral Aperture and the Point of Orbicularis Engagement Using EEG Signalling.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
February 21, 2022 (Anticipated)
Study Completion Date
February 21, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
National Health Service, United Kingdom, Royal Free Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We aim to establish the point at which glare from bright lights begins to engage our eyelids - causing us to "squint". We will be using a video camera with an LED ring light around it facing the volunteer and we will record the eyelid position as the light brightness is increased gradually. Many studies have looked at the effect glare has on a person through qualitative questionnaires but few have been able to quantify this.
Detailed Description
Our study will aim to establish the point of orbicularis engagement based on luminous intensity Murray et al. created an Ocular Stress Monitor to see if the contracture of the muscles on the eyelid indicative of pain as a light source was increased in luminosity 8 Our study will go one step further by using video technology and a portable EEG machine to detect the pulses of lid contracture as luminosity of a ring light i s increased incrementally. An advanced calibrated datalogging LED light meter will simultaneously record the level of brightness to establish at which point the spike in EEG occurs. Screenshots from the video recording will be taken and accurate MRD1 measurements can be taken at the point of orbicular i s engagement. The scientific justification for this research question is twofold We wish to establish the threshold at which orbicularis engages such that palpebral aperture and MRD measurements are altered. This is relevant to the technique of taking these measurements in the clinical environment and the light intensity at which these measurements are taken. We wish to establish the light intensity which should not be exceeded to take these measurements. As photography becomes increasingly used in oculoplastic s clinics we envisage palpebral aperture and MRD1 measurements being performed digitally rather than manually These measurements are relevant to pre operative and post operative imaging, and surgical planning. Furthermore, our results maybe applicable more widely to industry, for example vehicle headlights, bicycle lights, camera flash, workplace lighting. Reference: Murray I, Plainis S, Carden D. The ocular stress monitor: a new device for measuring discomfort glare. Lighting Research Technology. 2002;34(3):231 239.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Ptoses
Keywords
Palpebral Aperture measurements

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The observation of eyelid positioning and EEG pulses from the eyelid on increasing brightness
Arm Type
Experimental
Arm Description
In a dimly lit room the participant will place their chin on the slit lamp We will use t he optimal background illumination used for Humphrey and Goldman visual fields which is 31.5 apostilbs (10Lux 9 They will look into the video camera placed 50cm away, which will have a dimmable remote control ring light fitted around it. The part icipant will have a reference measure taped to the headrest and three electrodes placed around the right eye. One active electrode place on the lower lid and one reference electrode towards the temporal margin and one earth electrode placed on the forehead The brightness of the ring light will be increased via the dimmer switch whilst simultaneously recording the lux with the LED light meter. The participant will be advised t o close their eyes if the brightness becomes uncomfortable and this will be repea ted three times.
Intervention Type
Other
Intervention Name(s)
Review of eyelid positioning in increasing brightness levels
Intervention Description
Up to 30 seconds, three times, looking into a video camera as glare is incrementally increased.
Primary Outcome Measure Information:
Title
The point at which the eyelid begins to contract under what brightness level
Description
Using a light meter, ring light, and EEG machine
Time Frame
All carried out within a 2 week period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged between 18 and 65 years of age A member of the Royal Free NHS trust Exclusion Criteria: No known ocular pathology No lid problems/ptosis or previous lid surgery No contact lenses in for duration of experiment No pseudophakia No neurological disease
Facility Information:
Facility Name
Ophthalmology, Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data findings will be presented to the department, all those involved at the next departmental meeting.

Learn more about this trial

The Effect of Varying Brightness on Palpebral Aperture

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