Back to resultsEye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
Primary Purpose
Dry Eye Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Eye mask
Sponsored by
About this trial
This is an interventional supportive care trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria: Patients with dry eye disease according to the OSDI test Exclusion Criteria: Patients with eye disease except dry eye Patients using systemic and ophthalmic drugs Patients using sleeping and sedative pills
Sites / Locations
- Hamideh Sabbaghi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Eye mask users
Non eye mask users
Arm Description
The eyes of the patients will be defined as the intervention
The eyes of the patients will be defined as the controls
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06016166
Brief Title
Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
Official Title
The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hamideh Sabbaghi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eye mask users
Arm Type
Experimental
Arm Description
The eyes of the patients will be defined as the intervention
Arm Title
Non eye mask users
Arm Type
No Intervention
Arm Description
The eyes of the patients will be defined as the controls
Intervention Type
Device
Intervention Name(s)
Eye mask
Intervention Description
The 3D eye mask with the ability to adjust for different faces and eliminate light
Primary Outcome Measure Information:
Title
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
Description
Tear film function is measured quantitatively and qualitatively by the Schirmer (based on millimeters) and TBUT ( based on seconds) test
Time Frame
between baseline and follow- ups of weeks 2 and 4
Title
The effect of using eye mask on sleep quality between baseline and follow- ups of weeks 2 and 4 in patients with dry eye
Description
Sleep quality is measured by PSQI test based on the obtained score
Time Frame
between baseline and follow- ups of weeks 2 and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with dry eye disease according to the OSDI test
Exclusion Criteria:
Patients with eye disease except dry eye
Patients using systemic and ophthalmic drugs
Patients using sleeping and sedative pills
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamideh Sabbaghi, PhD
Phone
989120285930
Email
sabbaghi.opt@gmail.com
Facility Information:
Facility Name
Hamideh Sabbaghi
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamideh Sabbaghi, PhD
Phone
989120285930
Email
sabbaghi.opt@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease
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