Effect of Periorbital Massage on Dry Eye Disease

Not Applicable

Active, not recruiting

• Conditions: Dry Eye
• Interventions: Diagnostic Test: Periorbital Massage Therapy; Other: Control Group (Standard Care)

• Registration Number: NCT06390644
• Lead Sponsor: Superior University

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-04
• Primary Completion: 2024-04-01
• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periorbital Massage Therapy	Periorbital Massage Therapy	Participants in this arm will receive periorbital massage therapy administered by a trained practitioner.
Control Group (Standard Care)	Control Group (Standard Care)	Participants in this arm will receive standard care for dry eye disease.

Primary Outcome Measures

Name	Time	Method
Schirmer Strips	12 Months	Schirmer's test is used to determine whether the eye produces enough tears to keep it moist. The test is performed by placing filter paper inside the lower lid of the eye. After 5 minutes, the paper is removed and tested for its moisture content.

Secondary Outcome Measures

Name	Time	Method
OSDI Questionnaire	12 Months	The Ocular Surface Disease Index (OSDI) is a questionnaire that has been validated to discriminate between normal, mild to moderate, and severe dry eye disease as defined by the physician's assessment and a composite disease severity score

Trial Locations

Locations (1)

Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home; 🇵🇰 Lahore, Punjab, Pakistan