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NCT06016166 Clinical Trial

Eye Mask on Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease

Dry Eye Disease Clinical Trial

Official title:
The Effects of Eye Mask on Increasing the Sleep Quality and Tear Layer Function in Patients With Dry Eye Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06016166
Other study ID # IR.SBMU.RETECH.REC.1402.099
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date December 1, 2024

Study information
Verified date August 2023
Source Shahid Beheshti University of Medical Sciences
Contact Hamideh Sabbaghi, PhD
Phone 989120285930
Email sabbaghi.opt@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 34
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Eye mask
The 3D eye mask with the ability to adjust for different faces and eliminate light

Locations
Country Name City State
Iran, Islamic Republic of Hamideh Sabbaghi Tehran

Sponsors (1)
Lead Sponsor Collaborator
Hamideh Sabbaghi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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