Eyelid massager effectiveness in meibomian gland dysfunction
| ISRCTN | ISRCTN18423965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18423965 |
| Secondary identifying numbers | v-3 |
- Submission date
- 06/02/2017
- Registration date
- 21/02/2017
- Last edited
- 14/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Dry eye disease is a common medical condition that occurs when the eyes do not make enough tears or the tears evaporate too quickly. This leads to the eyes becoming dry, red, and irritated. Symptoms include dryness, grittiness, soreness, burning, and temporarily blurred vision which usually improves after blinking. Blinking naturally helps express meibum (oil) from healthy meibomian glands in the eyelids. If these glands are blocked, the eyes become dry and the glands may eventually atrophy (waste away). Treatment to unblock the glands involves eyelid massage. This encourages meibum to flow from the glands and allows the eye surface to function normally. Clinical evidence indicates that tear film stability can be improved by expression of the meibomian glands by eyelid massage. However, there is a need for a hygienic and effective eyelid-massaging tool. Anecdotal evidence suggests that dry eye patients most frequently use their fingers to massage their eyelids in an incorrect and ineffective manner and this is one of the first studies to address this issue. The aim of this study is test an eyelid-massaging device along with a heated eye mask over a period of 3 months.
Who can participate?
Patients aged 18 or over with dry eye disease due to meibomian gland dysfunction
What does the study involve?
Participants are randomly allocated into two groups. Participants in the test group use an ‘Eyepeace’ eyelid massager along with a heated eye mask once daily for a period of 3 months. Participants in the control group use a non-heated (room temperature) eye mask once daily for a period of 3 months. The participants can keep the eyelid massager and the eye mask after the end of the study. All participants undergo eye examinations at the start of the study and after 2 weeks, 1 month, 2 months and 3 months.
What are the possible benefits and risks of participating?
The results will increase knowledge of dry eye disease which may benefit people in the future. Eyelid massage and heated eye masks are a safe and non-invasive technique to improve eye health. An allergy questionnaire is used at the start of the study to help identify and minimise any possible risks.
Where is the study run from?
Cathedral Eye Clinic (UK)
When is the study starting and how long is it expected to run for?
April to November 2017
Who is funding the study?
Cathedral Eye Clinic (UK)
Who is the main contact?
Prof. Jonathan Moore
Contact information
Scientific
9-91 Academy Street
Belfast
BT1 2LS
United Kingdom
 ORCID ID |
0000-0001-8451-9421 |
|---|
Study information
| Study design | Randomized parallel-assigned single-blind (investigator) treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN18423965_PIS_20Feb17.docx |
| Scientific title | Investigating the efficacy of the Eyepeace eyelid massager in patients with meibomian gland dysfunction related evaporative dry eye |
| Study hypothesis | Dry eye that occurs in patients with meibomian gland dysfunction is secondary to increased evaporation associated with decreased function of meibomian glands. Therefore expression of the meibomian glands with the Eyepeace eyelid massager will improve their dry eye condition. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Meibomian gland dysfunction |
| Intervention | Participants are randomised by random number generation to one of two groups (the researcher who tests the patients will not know whether they belong to the study group or control group): 1. Participants receive an ‘Eyepeace’ eyelid massager and heated eye mask (2 mins in a warm cup of water) on both eyes (test group) once daily 2. Participants receive a non-heated eye mask (control group) and use it once daily. All participants are instructed to use the treatment at the same time (morning) for 3 months. All participants undergo eye examinations at enrolment, baseline, and 2 weeks, 1 month, 2 months and 3 months after starting treatment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Tear film lipid layer thickness for right and left eyes, measured using images captured with Tearscope at 2 weeks, 1 month, 2 months and 3 months |
| Secondary outcome measures | Measured at baseline, 2 weeks, 1 month, 2 months and 3 months: 1. Tear film quality, measured as non-invasive tear break up time using a slit-lamp-mounted TearScope on each eye in random order 2. Meibomian gland function, based upon meibum quality and expressibility using a slit-lamp following firm digital pressure to the eyelid margins 3. Ocular redness/hyperaemia, measured using images captured non-invasively using a digital slit-lamp photography of the limbal and temporal conjunctiva for both eyes 4. Tear osmolarity for right and left eyes, measured using TearLab 5. Corneal sensitivity for right and left eyes, measured using handheld esthesiometer (Cochet-Bonnet) 6. Corneal staining for right and left eyes, assessed via instillation of lissamine green and fluorescein sodium and using the Oxford corneal grading score 7. Dry eye symptoms for right and left eyes, measured using the Ocular Surface Disease Index 8. Visual satisfaction, measured with Quality of Vision (QOV) questionnaire scores 9. Longitudinal progress of the patient’s dry eye symptoms and adherence to dry eye treatment, measured with the D-III questionnaire |
| Overall study start date | 01/04/2017 |
| Overall study end date | 01/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 total; 50 participants test group, 50 participants control group. Taking into consideration the possibility of 10-15 dropouts participants in each group. |
| Participant inclusion criteria | 1. Aged 18 or over 2. Have otherwise healthy eyes 3. Are prepared not to wear contact lens for 3 months of the trial 4. Have a NITBUT <10s 5. OSDI score: greater than or equal to 12 6. Symptom frequency at least "some of the time" 7. 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 |
| Participant exclusion criteria | 1. Conjunctivitis 2. Meibomian cysts 3. Styes 4. Damage to the cornea 5. Ocular injury 6. Cataract or laser refractive surgery in the past 6-months 7. Increased intraocular pressure (primary or secondary) 8. Any chronic disease of the eye |
| Recruitment start date | 01/06/2017 |
| Recruitment end date | 01/08/2017 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
BT1 2LS
United Kingdom
Sponsor information
Hospital/treatment centre
89-91 Academy Street
Belfast
BT1 2LS
Northern Ireland
United Kingdom
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers of this study plan to publish the results in a health journal so others can read about and learn from the results of the study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jonathan Moore. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 20/02/2017 | 14/03/2017 | No | Yes |
Additional files
- ISRCTN18423965_PIS_20Feb17.docx
- Uploaded 14/03/2017
Editorial Notes
14/03/2017: Participant information sheet uploaded.
