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

NCT ID: NCT06016166

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Eye mask users

The eyes of the patients will be defined as the intervention

Group Type EXPERIMENTAL

Eye mask

Intervention Type DEVICE

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

Non eye mask users

The eyes of the patients will be defined as the controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eye mask

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamideh Sabbaghi

OTHER

Sponsor Role lead

Responsible Party

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Hamideh Sabbaghi

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hamideh Sabbaghi

Tehran, , Iran

Site Status

Countries

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Iran

Central Contacts

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Hamideh Sabbaghi, PhD

Role: CONTACT

989120285930

Facility Contacts

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Hamideh Sabbaghi, PhD

Role: primary

989120285930

Other Identifiers

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IR.SBMU.RETECH.REC.1402.099

Identifier Type: -

Identifier Source: org_study_id

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