Acceptability of the Use of USB-Powered Eye Mask

Sponsor
Singapore National Eye Centre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03840668
Collaborator
Ngee Ann Polytechnic Singapore (Other)
30
1
1
16
1.9

Study Details

Study Description

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 to an online database whenever the device is used. Through our copyrighted Android/ iOS application, you or your physician can monitor the frequency of eyelid warming over a long period.

Condition or Disease Intervention/Treatment Phase
  • Device: USB Eye Mask
N/A

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 to an online database whenever the device is used. Through our copyrighted Android/ iOS application, 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Acceptance and Monitoring of the Use of USB-Powered Eye Mask
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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 3 months.

Outcome Measures

Primary Outcome Measures

  1. Acceptance of USB eyemask questionnaire [14 days]

    Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Singapore Eye Research Institute Singapore Singapore 169856

Sponsors and Collaborators

  • Singapore National Eye Centre
  • Ngee Ann Polytechnic Singapore

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT03840668
Other Study ID Numbers:
  • R1507/6/2018
  • 2018/2102
First Posted:
Feb 15, 2019
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022