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Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.
Study Design
Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EyeBag | Experimental | Eye self-treated with heated eyebag in the morning and evening each day as per manufacturer's instructions (see http://www.eyebagcompany.com/how) |
|
| Placebo | Placebo Comparator | Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeBag | Device | fabric bag of beads which can be heated in a microwave |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Symptoms | Ocular symptomology: Ocular Surface Disease Index for right and left eyes | Between baseline and 2 weeks |
| Change in Tear Film Quality | Non-invasive tear break up time: 3 measurements per eye | Between baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular redness | Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured | Between baseline and 2 weeks |
| Change in Lipid layer thickness | Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope |
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Inclusion Criteria:
Exclusion Criteria:
• Blepharitis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston University | Birmingham | West Midlands | B47ET | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24997178 | Result | Bilkhu PS, Naroo SA, Wolffsohn JS. Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye. Br J Ophthalmol. 2014 Dec;98(12):1707-11. doi: 10.1136/bjophthalmol-2014-305220. Epub 2014 Jul 4. |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Placebo | Other |
|
|
| Between baseline and 2 weeks |
| Change in Meibomian Glands | Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score | Between baseline and 2 weeks |