NCT02596919

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

August 13, 2015

Last Update Submit

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

OTHER

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

Other: photography

Interventions

photography of meibomian glands

No arms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Photography

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

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

Locations