NCT06016166

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Hamideh Sabbaghi · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Eye mask	The 3D eye mask with the ability to adjust for different faces and eliminate light

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

1 site across 1 country: Iran