Meibomian Gland DysfunctionNCT02596919
Fast Infrared Meibography (Photography)
A study testing photography in people with Meibomian Gland Dysfunction, run by Queen Victoria Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Infrared meibography is a useful technique in the evaluation of meibomian gland disease (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen in the Corneo-Plastic Unit (CPU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- photography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending the CPU will be offered the opportunity to take part if they comply with the following:
- Over 18 years of age
- Able to give their informed consent
Who cannot join
- Patients under the age of 18 years of age
- Poor understanding of language
- Ocular allergies
- History of contact lens wear
- History of eye or eyelid surgery
- Systemic or ocular diseases that may interfere with tear film production or function.
Show all 9Show fewer
- Use of systemic medication with tetracycline derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD.
- Use of topical ciclosporin-A or steroids beginning within the last month.
- Refusal for patient's own GP to be informed of participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, W Sussex, RH19 3DZ
About this study
Infrared meibography is a useful technique in the evaluation of meibomian gland disease (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen in the Corneo-Plastic Unit (CPU). Many parameters have been used to evaluate MGD including tear film break-up time, lid margin abnormalities, and Schirmer tear test values. Direct visualization of meibomian glands by infrared meibography has been shown to correlate well with these parameters.
Although infrared meibography was developed more than 30 years ago, it is not widely used. This has probably been due to the need for special equipment, examiner time and expertise and patient discomfort during the examination. Analysis of the acquired images also needed to be from video review with extraction of video stills - a time-consuming process.
Investigators aim to pilot a rapid non-contact (non-painful) method of obtaining infrared images of meibomian glands using equipment already available at QVH. This pilot study will validate the technique and check patient acceptability. Investigators are hopeful this test could be used as a useful tool for future research into dry eye conditions and MGD.
Read the detailed description
Patients will receive a patient information sheet in the post with their Eye Clinic appointment letter. To be clear, the points listed below would form the standard of care for a dry eye patient attending the clinic, apart from the additional infrared photographic image taken for the study (point 6).
In the Consultation room, the study will be explained to participants by one of the investigators. If they agree to participate, a consent form will be signed by the participant and an investigator. They will be questioned regarding the absence or presence of ocular symptoms using a previously validated and accepted scoring scale (Ocular Surface Disease Index - OSDI). This questionnaire will allow patients to score their degree of dry eye symptoms.
Participants will then undergo:
- Schirmers tear test of production.
- Clinical slit lamp examination to look for abnormalities of the upper and lower lid margins.
- Fluorescein staining of the ocular surface (divided into 3 zones comprising nasal conjunctival, corneal, and temporal conjunctival areas).
- Observation of tear film break-up time (TBUT).
- Digital pressure was applied to the upper tarsus, and the degree of ease with which meibomian secretion (meibum) is induced, evaluated semi-quantitatively. Eversion of upper and lower eyelids in the clinic is part of the standard ocular examination.
- In the photography department, the upper and lower eyelids will then be everted and non-contact infrared photographs taken. Partial or complete loss of Meibomian glands will be scored according to the meiboscore for each eyelid. After the image is taken, patient experience will be gathered on a five-point Lickert scale score sheet.
Outcome measures To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography and both clinical examination findings and questionnaire scores regarding eyelid and tear film function in the population.
To assess patient experience and acceptability of the intervention.
4.0 Selection and withdrawal of Subjects 4.1 Inclusion criteria
Patients attending the CPU will be offered the opportunity to take part if they comply with the following:
- Over 18 years of age
- Able to give their informed consent
4.2 Exclusion criteria:
- Patients under the age of 18 years of age
- Poor understanding of language
- Ocular allergies
- History of contact lens wear
- History of eye or eyelid surgery
- Systemic or ocular diseases that may interfere with tear film production or function.
- Use of systemic medication with tetracycline derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD.
- Use of topical ciclosporin-A or steroids beginning within the last month.
- Refusal for patient's own GP to be informed of participation.
5.0 Treatment of subjects Participants will undergo the standard of care in the Corneo-Plastic Unit, but will also be examined and photographed by the infrared technique.
6.0 Assessment of Efficacy Through the assessment described above, a statistical analysis between OSDI score, ocular surface and Meibomian gland score will be possible. We will analyse the findings to see if there is any relationship between the patient symptoms and level of Meibomian gland dysfunction.
7.0 Assessment of Safety Any side effects reported by the patient and/or observed by the clinician will be recorded. Data regarding patient experience of the test will also be collected.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- photography
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photographyOther
photography of meibomian glands
| Study group | Role | What they receive |
|---|---|---|
| No arms | Other | No randomisation therefore no arms. All patients will receive the same research treatment. Receives: Other: photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with clinical examination findings
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography and both clinical examination findings and questionnaire scores regarding eyelid and tear film function in the population. Schirmer 1 Tear Test A Schirmer 1 test evaluates baseline secretion.
- 0.5% proxymetacaine eye drops are administered to achieve topical anaesthesia.
- Schirmer strips are then inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding corneal touch.
- All patients are seated at rest with their eyes closed.
- The length of wetting strips in millimeters is recorded after 5 minutes.
The Schirmer Test is interpreted after 5 minutes as follows:
- Normal aqueous tear production is supported by measurements of > 15 mm.
- Mild-moderate reduction of aqueous production: 5mm-14mm.
- Severe dryness due to reduced tear production is < 5mm.
Measured: 5 minutes
Secondary outcomes (1)
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with questionnaire scores
OSDI Questionnaire (OSDI) - A validated and accepted scoring scale, with scores ranging from 0 (None of the time) to 4 (All of the time).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: After review, recruitment was halted as the images obtained needed improvement. To be presented at the British Oculoplastic Surgery Society in Jun 17
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Victoria Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596919
- Sponsor's protocol ID
- RPC302
- Status last verified
- May 2017
- First submitted
- 13 Aug 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Infrared Meibography (Photography)
- ClinicalTrials.gov ID
- NCT02596919
- Acronym / sponsor ID
- RPC302
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After review, recruitment was halted as the images obtained needed improvement. To be presented at the British Oculoplastic Surgery Society in Jun 17
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Victoria Hospital NHS Foundation TrustOther government
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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.
Infrared meibography is a useful technique in the evaluation of meibomian gland disease (MGD). MGD is a major cause of dry eye symptoms, affecting a large number of patients seen in the Corneo-Plastic Unit (CPU). Many parameters have been used to evaluate MGD including tear film break-up time, lid margin abnormalities, and Schirmer tear test values. Direct visualization of meibomian glands by infrared meibography has been shown to correlate well with these parameters.
Although infrared meibography was developed more than 30 years ago, it is not widely used. This has probably been due to the need for special equipment, examiner time and expertise and patient discomfort during the examination. Analysis of the acquired images also needed to be from video review with extraction of video stills - a time-consuming process.
Investigators aim to pilot a rapid non-contact (non-painful) method of obtaining infrared images of meibomian glands using equipment already available at QVH. This pilot study will validate the technique and check patient acceptability. Investigators are hopeful this test could be used as a useful tool for future research into dry eye conditions and MGD.
Detailed description
Patients will receive a patient information sheet in the post with their Eye Clinic appointment letter. To be clear, the points listed below would form the standard of care for a dry eye patient attending the clinic, apart from the additional infrared photographic image taken for the study (point 6).
In the Consultation room, the study will be explained to participants by one of the investigators. If they agree to participate, a consent form will be signed by the participant and an investigator. They will be questioned regarding the absence or presence of ocular symptoms using a previously validated and accepted scoring scale (Ocular Surface Disease Index - OSDI). This questionnaire will allow patients to score their degree of dry eye symptoms.
Participants will then undergo:
- Schirmers tear test of production.
- Clinical slit lamp examination to look for abnormalities of the upper and lower lid margins.
- Fluorescein staining of the ocular surface (divided into 3 zones comprising nasal conjunctival, corneal, and temporal conjunctival areas).
- Observation of tear film break-up time (TBUT).
- Digital pressure was applied to the upper tarsus, and the degree of ease with which meibomian secretion (meibum) is induced, evaluated semi-quantitatively. Eversion of upper and lower eyelids in the clinic is part of the standard ocular examination.
- In the photography department, the upper and lower eyelids will then be everted and non-contact infrared photographs taken. Partial or complete loss of Meibomian glands will be scored according to the meiboscore for each eyelid. After the image is taken, patient experience will be gathered on a five-point Lickert scale score sheet.
Outcome measures To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography and both clinical examination findings and questionnaire scores regarding eyelid and tear film function in the population.
To assess patient experience and acceptability of the intervention.
4.0 Selection and withdrawal of Subjects 4.1 Inclusion criteria
Patients attending the CPU will be offered the opportunity to take part if they comply with the following:
- Over 18 years of age
- Able to give their informed consent
4.2 Exclusion criteria:
- Patients under the age of 18 years of age
- Poor understanding of language
- Ocular allergies
- History of contact lens wear
- History of eye or eyelid surgery
- Systemic or ocular diseases that may interfere with tear film production or function.
- Use of systemic medication with tetracycline derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD.
- Use of topical ciclosporin-A or steroids beginning within the last month.
- Refusal for patient's own GP to be informed of participation.
5.0 Treatment of subjects Participants will undergo the standard of care in the Corneo-Plastic Unit, but will also be examined and photographed by the infrared technique.
6.0 Assessment of Efficacy Through the assessment described above, a statistical analysis between OSDI score, ocular surface and Meibomian gland score will be possible. We will analyse the findings to see if there is any relationship between the patient symptoms and level of Meibomian gland dysfunction.
7.0 Assessment of Safety Any side effects reported by the patient and/or observed by the clinician will be recorded. Data regarding patient experience of the test will also be collected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No arms | Other | Other: photographyNo randomisation therefore no arms. All patients will receive the same research treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients attending the CPU will be offered the opportunity to take part if they comply with the following:
- Over 18 years of age
- Able to give their informed consent
Key exclusion criteria (9 listed)
- Patients under the age of 18 years of age
- Poor understanding of language
- Ocular allergies
- History of contact lens wear
- History of eye or eyelid surgery
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 |
|---|---|---|
| photographyphotography of meibomian glands | Other | No arms |
Primary outcome
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with clinical examination findings
Time frame: 5 minutes
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography and both clinical examination findings and questionnaire scores regarding eyelid and tear film function in the population. Schirmer 1 Tear Test A Schirmer 1 test evaluates baseline secretion. 1. 0.5% proxymetacaine eye drops are administered to achieve topical anaesthesia. 2. Schirmer strips are then inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding corneal touch. 3. All patients are seated at rest with their eyes closed. 4. The length of wetting strips in millimeters is recorded after 5 minutes. The Schirmer Test is interpreted after 5 minutes as follows: * Normal aqueous tear production is supported by measurements of > 15 mm. * Mild-moderate reduction of aqueous production: 5mm-14mm. * Severe dryness due to reduced tear production is < 5mm.
1 secondary outcome
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with questionnaire scores
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: After review, recruitment was halted as the images obtained needed improvement. To be presented at the British Oculoplastic Surgery Society in Jun 17). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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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 photography in people with Meibomian Gland Dysfunction, run by Queen Victoria Hospital NHS Foundation Trust 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 May 2017. 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?
The study was stopped early (reason given: After review, recruitment was halted as the images obtained needed improvement. To be presented at the British Oculoplastic Surgery Society in Jun 17). 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?
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with clinical examination findings (time frame: 5 minutes). 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 9 May 2017.