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

S

Superior University

Status

Active, not recruiting

Conditions

Dry Eye Syndrome

Treatments

Combination Product: Warm Compress
Diagnostic Test: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT06914232
MSRSW/Batch-Fall23/817

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Warm Compress
Experimental group
Treatment:
Combination Product: Warm Compress
Standard Care
Active Comparator group
Treatment:
Diagnostic Test: Standard Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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