Comparison of an automated thermodynamic treatment system (LipiFlow ®) and eyelid warm compress for the treatment of meibomian gland dysfunctio

Phase 4

Completed

• Conditions: moderate severity of meibomian gland dysfunction (MGD).; Meibomian gland dysfunction, warm compress, LipiFlow®

• Registration Number: TCTR20170905001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-06-30
• Study Start: 2017-09-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patients at least 18 years of age who had moderate severity of meibomian gland obstruction, defined as a Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores of 6-12 or lipid layer thickness (LLT) scores of 40-70 ICU (Interferometric Color Units), measured by using LipiView® (TearScience Inc., Morrisville, NC) or a meibomian gland score of 0-2 from Meibography® (Oculus, Wetzlar, Germany) or the number of expressible meibomian glands (EMG) yielding secretion of 3-6 glands of the lower eyelid.

Exclusion Criteria

patients with systemic diseases resulting in dry eyes such as systemic lupus erythematosus, rheumatoid arthritis, allergic diseases, etc., patients who had eyelid abnormalities, previous ocular surgery or trauma, and patients who used systemic medication affecting dry eyes such as antihistamines, tetracycline derivatives, isotretinoin and topical cyclosporine A or steroid within 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of a single thermal pulsation system treatment (LipiFlow ®) compared with 1 year and 6 months total SPEED scores, LipiView®

Secondary Outcome Measures

Name	Time	Method
Knowledge in management of vaginal pessary 2 weeks questionnaire