Clinical trial NCT03840668: Healthy Living Through Personalized Monitoring of Eyelid Care
Official title: Healthy Living Through Personalized Monitoring of Eyelid Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: USB eyemask
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: Ngee Ann Polytechnic Singapore
First posted: 2019-02-15
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period.

Detailed description: Dry eye is a very common condition that can cause blurring of vision associated with reading, grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is effective to control this condition and increase the tear film layer thickness.

Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period. To further encourage eyelid warming to be performed more frequently, the signal can also be sent to a participating games server which hastens progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry eye can now be a way to treat dry eye.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be 21 years or older.
2. Subject must have severe MGD
3. Subject must be willing to answer the questions in the questionnaire
4. Subject must be willing to use the USB-powered eyemask as instructed
5. Subject must have the ability to provide informed consent
6. Subject must be willing to come back for follow-up visit

Exclusion Criteria:

1. Any other specified reason as determined by the clinical investigator.
2. Is pregnant, lactating or planning a pregnancy.

Primary outcomes:
measure: Acceptance of USB eyemask questionnaire
timeFrame: 2 months +/-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore Eye Research Institute
name: Louis Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References: