Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
1 other identifier
interventional
34
1 country
1
Brief Summary
This randomized clinical trial (RCT) was aimed to determine the effects of eye masking on sleep quality and tear layer function in patients with dry eye disease. In this regard, a total of 34 patients with dry eye disease aged between 20 to 35 years old will be participated. They will be randomly divided into case and control (n=17) groups. Patients in the case group will be instructed to wear the eye mask as long as two weeks and the controls will be recommended to not wear it at the same time. Afterwards, the eye mask application will be cross- over for the next 2 hours between the two groups. Tear layer will be investigated in baseline and repeated in both follow- ups of weeks 2 and 4, either quantitatively and qualitatively, by using Schirmer and TBUT tests. Furthermore, the sleep quality will be checked by the PSQI test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 29, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 29, 2023
August 1, 2023
11 months
August 15, 2023
August 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
The effect of using eye mask on tear layer functions between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test
between baseline and follow- ups of weeks 2 and 4
The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
Sleep quality is measured by PSQI test based on the obtained score
between baseline and follow- ups of weeks 2 and 4
Study Arms (2)
Eye mask users
EXPERIMENTALThe eyes of the patients will be defined as the intervention
Non eye mask users
NO INTERVENTIONThe eyes of the patients will be defined as the controls
Interventions
The 3D eye mask with the ability to adjust for different faces and eliminate light
Eligibility Criteria
You may qualify if:
- Patients with dry eye disease according to the OSDI test
You may not qualify if:
- Patients with eye disease except dry eye
- Patients using systemic and ophthalmic drugs
- Patients using sleeping and sedative pills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hamideh Sabbaghilead
Study Sites (1)
Hamideh Sabbaghi
Tehran, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 15, 2023
First Posted
August 29, 2023
Study Start
October 1, 2023
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
August 29, 2023
Record last verified: 2023-08