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

Hamideh Sabbaghi

Status: Not yet enrolling

Conditions: Dry Eye Disease

Treatments: Device: Eye mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06016166

IR.SBMU.RETECH.REC.1402.099

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Eye mask users

Experimental group

Description:

The eyes of the patients will be defined as the intervention

Treatment:

Device: Eye mask

Non eye mask users

No Intervention group

Description:

The eyes of the patients will be defined as the controls