EyeBag Effectiveness in Meibomian Gland Dysfunction
- Conditions
- Meibomian Gland Dysfunction
- Interventions
- Device: EyeBagOther: Placebo
- Registration Number
- NCT01870180
- Lead Sponsor
- Aston University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 18 or over
- Have otherwise healthy eyes
- Are prepared not to wear contact lens for the 2 weeks of the trial
- Have a NITBUT <10s
- OSDI score: greater than or equal to 12
- Symptom frequency at least "some of the time"
- Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid
• Blepharitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EyeBag EyeBag 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 Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated
- Primary Outcome Measures
Name Time Method Change in Tear Film Quality Between baseline and 2 weeks Non-invasive tear break up time: 3 measurements per eye
Change in Ocular Symptoms Between baseline and 2 weeks Ocular symptomology: Ocular Surface Disease Index for right and left eyes
- Secondary Outcome Measures
Name Time Method Change in Lipid layer thickness Between baseline and 2 weeks Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope
Change in Ocular redness Between baseline and 2 weeks Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured
Change in Meibomian Glands Between baseline and 2 weeks Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score
Trial Locations
- Locations (1)
Aston University
🇬🇧Birmingham, West Midlands, United Kingdom