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OpenTrials
Active, Not Recruiting

NCT Number: NCT06914232

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hakeem mahmood trust hospital address alam chowk mean baipas

Guiranwala, Punjab Province, Pakistan

About this study

This study aims to evaluate the effectiveness of perioperative warm compress therapy (TPT) in improving tear film stability and reducing dry eye symptoms following cataract surgery. This randomized controlled trial (RCT) will involve 54 patients with estimated attrition rate 60 participants aged 50-70 with moderate to severe dry eye symptoms and tear film instability, as indicated by high Ocular Surface Disease Index (OSDI) scores. Participants will be randomly assigned to either an intervention group, receiving warm compress therapy before and after surgery, or a control group receiving standard dry eye treatments for 6 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: 12 Months

    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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative Dry Eye Syndrome After Cataract Surgery: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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