Clinical trial NCT06914232: Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative DES
Official title: Efficacy of Warm Compress Therapy in Enhancing Tear Film Quality and Reducing Postoperative Dry Eye Syndrome After Cataract Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Hakeem mahmood trust hospital address alam chowk mean baipas
state: Punjab
Study officials:
References: