Eyelid PtosesNCT05210491
The Effect of Varying Brightness on Palpebral Aperture
A study testing Review of eyelid positioning in increasing brightness levels in people with Eyelid Ptoses, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eyelid Ptoses
- What is being tested?
- Review of eyelid positioning in increasing brightness levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2022to 21 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years of age
- A member of the Royal Free NHS trust
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ophthalmology, Royal Free Hospital
London, NW3 2QY
About this study
Official title: The Effect of Varying Brightness Levels on Palpebral Aperture and the Point of Orbicularis Engagement Using EEG Signalling.
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.
Read the 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.
- Conditions
- Eyelid Ptoses
- Being tested
- Review of eyelid positioning in increasing brightness levels
- Keywords
- Palpebral Aperture measurements
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of eyelid positioning in increasing brightness levelsOther
Up to 30 seconds, three times, looking into a video camera as glare is incrementally increased.
| Study group | Role | What they receive |
|---|---|---|
| The observation of eyelid positioning and EEG pulses from the eyelid on increasing brightness | Experimental | 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. Receives: Other: Review of eyelid positioning in increasing brightness levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
The point at which the eyelid begins to contract under what brightness level
Using a light meter, ring light, and EEG machine
Measured: All carried out within a 2 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start14 Jan 2022
- Primary completion21 Feb 2022 (estimated)
- Study completion21 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid PtosesStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210491
- Sponsor's protocol ID
- 1062/RD
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data findings will be presented to the department, all those involved at the next departmental meeting.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Varying Brightness Levels on Palpebral Aperture and the Point of Orbicularis Engagement Using EEG Signalling.
- ClinicalTrials.gov ID
- NCT05210491
- Acronym / sponsor ID
- 1062/RD
- Conditions
- Eyelid Ptoses
- Keywords
- Palpebral Aperture measurements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom, Royal Free Hospital NHS Foundation Trust
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 21 Feb 2022 (estimated)
- Study completion
- 21 Feb 2022 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The observation of eyelid positioning and EEG pulses from the eyelid on increasing brightness | Experimental | Other: Review of eyelid positioning in increasing brightness levelsIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 18 and 65 years of age
- A member of the Royal Free NHS trust
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Review of eyelid positioning in increasing brightness levelsUp to 30 seconds, three times, looking into a video camera as glare is incrementally increased. | Other | The observation of eyelid positioning and EEG pulses from the eyelid on increasing brightness |
Primary outcome
The point at which the eyelid begins to contract under what brightness level
Time frame: All carried out within a 2 week period
Using a light meter, ring light, and EEG machine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: Undecided. Data findings will be presented to the department, all those involved at the next departmental meeting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Review of eyelid positioning in increasing brightness levels in people with Eyelid Ptoses, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The point at which the eyelid begins to contract under what brightness level (time frame: All carried out within a 2 week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.