Study Stopped
After review, recruitment was halted as the images obtained needed improvement. To be presented at the British Oculoplastic Surgery Society in Jun 17
Fast Infrared Meibography (Photography)
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 9, 2017
May 1, 2017
5 months
August 13, 2015
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (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.
5 minutes
Secondary Outcomes (1)
To examine for a correlation between morphologic changes in meibomian glands visible on infrared photography with questionnaire scores
5 minutes
Study Arms (1)
No arms
OTHERNo randomisation therefore no arms. All patients will receive the same research treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, W Sussex, RH19 3DZ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2015
First Posted
November 4, 2015
Study Start
September 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 9, 2017
Record last verified: 2017-05