The Effect of Varying Brightness on Palpebral Aperture

NCT ID: NCT05210491

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eyelid Ptoses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

Review of eyelid positioning in increasing brightness levels

Intervention Type OTHER

Up to 30 seconds, three times, looking into a video camera as glare is incrementally increased.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Review of eyelid positioning in increasing brightness levels

Up to 30 seconds, three times, looking into a video camera as glare is incrementally increased.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Health Service, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ophthalmology, Royal Free Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1062/RD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dual Wavelength OCT
NCT03843840 COMPLETED
Pain Perception at Laser Treatment
NCT01033968 COMPLETED PHASE4
Coloured-light in Retinitis Pigmentosa.
NCT06224114 NOT_YET_RECRUITING NA
Adaptive Optics Retinal Imaging
NCT02317328 RECRUITING