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Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime

NCT01769105 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-10-07

Study results available
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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.

Conditions

  • Meibomian Gland Dysfunction

Interventions

DEVICE

Lipiflow

Patients receive a single Lipiflow-treatment

BEHAVIORAL

Lid hygiene regime

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

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Gerd Geerling, M.D. · Deparmtent of ophthalmology, Heinrich-Heine-University, Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769105 on ClinicalTrials.gov