Healthy Living Through Personalized Monitoring of Eyelid Care

Dry Eye Clinical Trial

Official title:

Healthy Living Through Personalized Monitoring of Eyelid Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03840668
• Other study ID #: R1507/6/2018
• Secondary ID: 2018/2102
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: November 2024

Study information

• Verified date: March 2024
• Source: Singapore National Eye Centre
• Contact: Louis Tong, PhD
• Phone: 65767200
• Email: louis.tong.h.t[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

Device:
• USB Eye Mask
To evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 2 months.

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore National Eye Centre	Ngee Ann Polytechnic Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of USB eyemask questionnaire	Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask	2 months +/-14 days