Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES

NCT06914232 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/817
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye disease (DED) is a multifactorial condition often exacerbated by cataract surgery, leading to discomfort and visual disturbances. Meibomian gland dysfunction (MGD), a key cause of DED, contributes to tear film instability, which can be managed with warm compress therapy.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  The Ocular Surface Disease Index (OSDI) is a 12-question questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function, scored on a scale of 0 to 100, with higher scores indicating greater disability.

  12 Months

Study Arms (2)

Warm Compress

EXPERIMENTAL

Combination Product: Warm Compress

Standard Care

ACTIVE COMPARATOR

Diagnostic Test: Standard Care

Interventions

Warm Compress COMBINATION_PRODUCT

The intervention involves perioperative Warm compress therapy administered to the participants in the intervention group before and after cataract surgery for 3 seesions per week for 6 weeks. The therapy aims to enhance tear film stability and alleviate symptoms of dry eye by delivering warm compress to the meibomian glands to restore their function. Participants will undergo a session of warm compress therapy prior to surgery and another one following the surgery.

Warm Compress

Standard Care DIAGNOSTIC_TEST

The control group will receive standard care, which includes artificial tears or other conventional methods for dry eye management for 3 sessions per week for 6 weeks. , but they will not receive Warm Compress therapy.

Standard Care

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 30 to 70 years
• Patients scheduled for cataract surgery (both unilateral and bilateral).
• Patients with preoperative moderate to severe dry eye symptoms, which will be assessed using the Ocular Surface Disease Index (OSDI).

You may not qualify if:

• Patients with OSDI, indicating severe dry eye disease which suggests severe dry eye disease. These patients might require more intensive treatments beyond Warm Compress therapy.
• Patients with systemic diseases (e.g., rheumatoid arthritis, lupus) that affect tear production or who are using medications that severely reduce tear production (e.g., chronic use of antihistamines or systemic corticosteroids).
• Patients with significant pre-existing corneal pathology (e.g., corneal dystrophies, corneal scars) that could affect the results of cataract surgery or thermal pulsation therapy.
• Patients with active ocular infections (e.g., conjunctivitis, keratitis) or inflammation at the time of screening or surgery.
• Patients with a history of previous ocular surgeries (excluding cataract surgery) in the study eye, such as refractive surgery (LASIK, PRK) or corneal transplants.
• Patients with a known allergy or contraindication to Warm Compress therapy or its components.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Hakeem mahmood trust hospital address alam chowk mean baipas

Gujranwala, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start: March 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: February 20, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)