Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

Official title: A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction

Status Completed

Clinical Trial Summary

This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.

Clinical Trial Description

This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).

Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score >23, total meibomian gland secretion (MGS) score < or =12 in the lower lid of each eye, and tear break-up time (TBUT) < 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks. ;

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

• NCT number: NCT06326931
• Study type: Interventional
• Source: Jacksoneye
• Status: Completed
• Phase: Phase 4
• Start date: June 24, 2022
• Completion date: June 22, 2023