Effect of Periorbital Massage on Dry Eye Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Diagnostic test: Periorbital Massage Therapy; Other: Control Group (Standard Care)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periorbital Massage Therapy; Participants in this arm will receive periorbital massage therapy administered by a trained practitioner.	Diagnostic test: 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.
Other: Control Group (Standard Care); Participants in this arm will receive standard care for dry eye disease.	Other: 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer Strips	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.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI Questionnaire	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	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: MSRSW/Batch-Fall22/701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No