Effect of Periorbital Massage on Dry Eye Disease
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedApril 30, 2024
April 1, 2024
6 months
April 25, 2024
April 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
OSDI Questionnaire
12 Months
Study Arms (2)
Periorbital Massage Therapy
EXPERIMENTALParticipants in this arm will receive periorbital massage therapy administered by a trained practitioner.
Control Group (Standard Care)
OTHERParticipants in this arm will receive standard care for dry eye disease.
Interventions
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.
Participants in this arm will receive standard care for dry eye disease, which include artificial tears. They will not receive periorbital massage therapy."
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 25, 2024
First Posted
April 30, 2024
Study Start
October 1, 2023
Primary Completion
April 1, 2024
Study Completion
September 30, 2024
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share