Effect of Periorbital Massage on Dry Eye Disease

NCT ID: NCT06390644

Last Updated: 2024-04-30

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-09-30

Brief Summary

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This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.

Detailed Description

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Participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. The intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. The primary outcome measure will be assessed using the Schirmer Strips and Ocular Surface Disease Index (OSDI) questionnaire. This study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Periorbital Massage Therapy

Participants in this arm will receive periorbital massage therapy administered by a trained practitioner.

Group Type EXPERIMENTAL

Periorbital Massage Therapy

Intervention Type DIAGNOSTIC_TEST

Participants in this arm will receive periorbital massage therapy administered by a trained practitioner. The massage technique will involve gentle circular motions around the eye sockets and brow bone area, aiming to improve eyelid and tear gland function.

Control Group (Standard Care)

Participants in this arm will receive standard care for dry eye disease.

Group Type OTHER

Control Group (Standard Care)

Intervention Type OTHER

Participants in this arm will receive standard care for dry eye disease, which include artificial tears. They will not receive periorbital massage therapy."

Interventions

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Periorbital Massage Therapy

Participants in this arm will receive periorbital massage therapy administered by a trained practitioner. The massage technique will involve gentle circular motions around the eye sockets and brow bone area, aiming to improve eyelid and tear gland function.

Intervention Type DIAGNOSTIC_TEST

Control Group (Standard Care)

Participants in this arm will receive standard care for dry eye disease, which include artificial tears. They will not receive periorbital massage therapy."

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Symptoms of dry eye (such as burning, dryness or foreign body sensation)
* Ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction)
* Patients having moderate and severe dry eye disease according to schirmer test Willing and able to comply with the study protocol

Exclusion Criteria

* Active ocular infection
* Ocular surgery within past 3 months
* Use of contact lenses
* Use of systemic medications that can affect tear production or tear quality
* Pregnancy or lactation
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSRSW/Batch-Fall22/701

Identifier Type: -

Identifier Source: org_study_id

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