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Fast Infrared Meibography (Photography)

Primary Purpose

Meibomian Gland Dysfunction

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
photography
Sponsored by
Queen Victoria Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

Sites / Locations

  • Queen Victoria Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

No arms

Arm Description

No randomisation therefore no arms. All patients will receive the same research treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
August 13, 2015
Last Updated
May 8, 2017
Sponsor
Queen Victoria Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02596919
Brief Title
Fast Infrared Meibography (Photography)
Official Title
Fast Infrared Meibography (Photography)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
After review, recruitment was halted as the images obtained needed improvement. To be presented at the British Oculoplastic Surgery Society in Jun 17
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Victoria Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No arms
Arm Type
Other
Arm Description
No randomisation therefore no arms. All patients will receive the same research treatment.
Intervention Type
Other
Intervention Name(s)
photography
Intervention Description
photography of meibomian glands
Primary Outcome Measure Information:
Title
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with clinical examination findings
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with questionnaire scores
Description
OSDI Questionnaire (OSDI) - A validated and accepted scoring scale, with scores ranging from 0 (None of the time) to 4 (All of the time).
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Facility Information:
Facility Name
Queen Victoria Hospital NHS Foundation Trust
City
E Grinstead
State/Province
W Sussex
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom

12. IPD Sharing Statement

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Fast Infrared Meibography (Photography)

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