CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Lipiflow +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01769105
NCT01769105N/ACompleted

Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime

Heinrich-Heine University, Duesseldorf·interventional·Posted Jan 16, 2013·Updated Oct 7, 2014

In Brief

A clinical study evaluating Lipiflow and Lid hygiene regime for Meibomian Gland Dysfunction. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However, treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia followed by lid massage and lid margin cleansing over several months. To the best of the investigators knowledge this is the first randomized prospective study to compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene regime. The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene regime.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartApr 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.5 years ago

Interventions

Lipiflowdevice

Patients receive a single Lipiflow-treatment

Lid hygiene regimebehavioral

Patients receive verbal and written instruction to perform lid hygiene twice daily