Condition category
Eye Diseases
Date applied
09/02/2018
Date assigned
14/02/2018
Last edited
13/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Inflammation can occur after laser or eye surgery, which can disrupt the tear film and eye surface and lead to short- or long-term dry eye syndrome, where the eyes do not make enough tears or the tears evaporate too quickly. This causes the eyes to become dry, red, and irritated. Reducing the inflammation can allow the eye surface to function normally. Blinking naturally helps express meibum (oil) from healthy meibomian glands in the eyelids. If these glands are blocked, the eyes become dry and inflamed. Treatment to unblock the glands involves eyelid massage. Tear film stability can be improved by expression of the meibomian glands by eyelid massage and consuming omega fatty acid supplements. However, there is a need for a hygienic and effective eyelid-massaging tool. Dry eye patients most frequently use their fingers to massage their eyelids in an incorrect and ineffective manner. Eyepeace is a new, unique, CE-marked medical device, designed to combat the issues of dry eye due to meibomian gland dysfunction. It is specially designed to be a non-invasive way to massage the meibomian glands, resulting in the treatment and prevention of dry eye. Anecdotal evidence suggests that patients experience improvements in symptoms after taking omega fatty acid supplements. This study aims to test the effects of combined use of Eyepeace (eyelid massager) for expressing the meibomian glands and oral Eye Nutrients (omega fatty acid supplements) for reducing eye surface inflammation over 3 months. Eye Nutrients has a unique blend of omega fatty acids, chosen to reduce inflammation of the eye surface.

Who can participate?
Patients aged 18 or over undergoing laser and/or intraocular lens (IOL) refractive surgery

What does the study involve?
Participants are randomly allocated to one of three groups. Group A uses the Eyepeace eyelid massager once a day from 1 week before surgery until the day before surgery, and also take Eye Nutrients, two capsules a day, from 1 week before surgery until 3 months after surgery. Group B takes Eye Nutrients only as described above. Group C does not use Eyepeace or Eye Nutrients. All participants undergo eye tests at the start of the study and 3 months after starting treatment.

What are the possible benefits and risks of participating?
There is no direct benefit to participants from being in this study. However, their participation may help others with dry eye in the future because of knowledge gained from this research. There are no risks associated with gently massaging the eyelids, consuming monitored omega fatty acid supplements and completing eye tests at the clinic. All tests on the eyes are general eye examinations performed by trained professionals.

Where is the study run from?
Cathedral Eye Clinic (UK)

When is the study starting and how long is it expected to run for?
March 2018 to July 2018

Who is funding the study?
Cathedral Eye Clinic (UK)

Who is the main contact?
Prof. Jonathan Moore

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Moore

ORCID ID

Contact details

Cathedral Eye Clinic
89-91 Academy Street
Belfast
BT1 2LS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18/CER/EPEN1

Study information

Scientific title

Investigate the improvements in tear film/ocular surface and visual recovery in laser and intraocular lens (IOL) refractive surgery patients preoperative using the Eyepeace (Eyelid massager) and Eye Nutrients (omega fatty acid supplement)

Acronym

EPEN

Study hypothesis

Symptoms of dry eye due to transient tear film disruption can occur in most patients post laser and intraocular lens (IOL) refractive surgery. Therefore expression of the meibomian glands with the 'Eyepeace' eyelid massager and consumption of 'Eye Nutrients' omega fatty acids will improve their condition.

Ethics approval

Not provided at time of registration

Study design

Randomized parallel-assigned single-blind (investigator) trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Dry eye

Intervention

Participants are randomised 1:1:1 by random number generation to one of three groups (the researcher who tests the patients will not know whether they belong to the study group A, study group B, or control group):

Treatment for Group A:
Eyepeace eyelid massage: once a day, to be started 1 week prior to laser or intraocular lens surgery, to be stopped one day prior to surgery
Eye nutrients: two capsules a day, to be started 1 week prior to laser or intraocular lens surgery, to be stopped 3 months after surgery

Treatment for Group B:
Eye nutrients: two capsules a day, to be started 1 week prior to laser or intraocular lens surgery, to be stopped 3 months after surgery

Treatment for Group C:
No Eyepeace or Eye nutrients

All participants undergo eye examinations at enrolment, baseline and 3 months after starting treatment.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

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, 1 month 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 high resolution digital slit-lamp photography of the limbal and temporal conjunctiva for both eyes. Ocular surface conjunctival blood-flow will also be observed and correlated with the heart beat/pulse of the patient
4. MMP-9, an inflammatory marker in the tears of patients with dry eye disease for right and left eyes, measured using a non-invasive RPS InflammaDry Detector
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. Tear volume for right and left eyes, measured using Phenol red thread test
8. Dry eye symptoms for right and left eyes, measured using the Ocular Surface Disease Index
9. Visual satisfaction, measured with Quality of Vision (QOV) questionnaire scores
10. Longitudinal progress of the patient’s dry eye symptoms and adherence to dry eye treatment, measured with the D-III questionnaire

Overall trial start date

01/03/2018

Overall trial end date

01/07/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

225

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

01/03/2018

Recruitment end date

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cathedral Eye Clinic
Belfast
BT1 2LS
United Kingdom

Sponsor information

Organisation

Cathedral Eye Research

Sponsor details

Cathedral Eye Clinic
89-91 Academy Street
Belfast
BT1 2LS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Cathedral Eye Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jonathan Moore.

Intention to publish date

01/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes