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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United Kingdom

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:

  1. Schirmers tear test of production.
  2. Clinical slit lamp examination to look for abnormalities of the upper and lower lid margins.
  3. Fluorescein staining of the ocular surface (divided into 3 zones comprising nasal conjunctival, corneal, and temporal conjunctival areas).
  4. Observation of tear film break-up time (TBUT).
  5. 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.
  6. 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.

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 groups in NCT02596919
Study groupRoleWhat they receive
No armsOtherNo 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.

  1. 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.

    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.

    Measured: 5 minutes

Secondary outcomes (1)
  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.

  1. First posted4 Nov 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionFeb 2016
  4. 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

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)
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

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.

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Fast Infrared Meibography (Photography) (NCT02596919) | AzTrials