Healthy Living Through Personalized Monitoring of Eyelid Care

March 17, 2024 updated by: Louis Tong, Singapore National Eye Centre
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry eye
Participants who will be using the USB-powered eye mask.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of USB eyemask questionnaire
Time Frame: 2 months +/-14 days
Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask
2 months +/-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Collaborators

Ngee Ann Polytechnic Singapore

Investigators

  • Principal Investigator: Louis Tong, PhD, Singapore Eye Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1507/6/2018
  • 2018/2102 (Registry Identifier: SingHealth CIRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on USB Eye Mask

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe