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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Finis, MD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01769105
First received: January 11, 2013
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Meibomian Gland Dysfunction
Device: Lipiflow
Behavioral: Lid hygiene regime

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Change of Dry Eye Symptoms [ Time Frame: after 3 month compared to baseline value ] [ Designated as safety issue: No ]

    The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI)

    Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness).

    OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms.



Secondary Outcome Measures:
  • Change of Break-up-time [ Time Frame: after 3 month compared to baseline value ] [ Designated as safety issue: No ]

    break-up-time is measured non-invasive with the Oculus Keratograph 5 M;

    The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication.


  • Change in Tear Film Osmolarity [ Time Frame: after 3 month compared to baseline value ] [ Designated as safety issue: No ]

    osmolarity is measured with the tear-lab;

    The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease.

    A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease.


  • Change in Lipid Layer Thickness [ Time Frame: after 3 month compared to baseline value ] [ Designated as safety issue: No ]

    lipid layer thickness (LLT) is measured with the Lipiview-interferometer;

    High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface.

    LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness.


  • Change in Expressible Meibomian Glands [ Time Frame: after 3 month compared to baseline value ] [ Designated as safety issue: No ]
    expressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Lid Hygiene Regime
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Behavioral: Lid hygiene regime
Patients receive verbal and written instruction to perform lid hygiene twice daily
Active Comparator: Lipiflow
Patients receive a singe Lipiflow-treatment
Device: Lipiflow
Patients receive a single Lipiflow-treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with meibomian gland dysfunction requiring treatment (defined below),
  • who have given their written consent to the study.
  • Meibomian gland dysfunction requiring treatment is classified by us as:
  • Speed score> 7, Lipiview <61 nm, MGE <5 of 15 open glands

Exclusion Criteria:

  • Excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study
  • Systemic medication with tetracyclin derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD that started <3 months before baseline examination
  • Topical cyclosporine-A or steroids that started <1 month before baseline examination
  • Ocular surgery or trauma <3 months before baseline examination
  • Any eyelid abnormalities
  • Systemic diseases resulting in dry eye.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01769105

Locations
Germany
Deparment of ophthalmology, Heinrich-Heine-University
Duesseldorf, Germany, D-40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Study Chair: Gerd Geerling, M.D. Deparmtent of ophthalmology, Heinrich-Heine-University, Duesseldorf
  More Information

Publications:
Responsible Party: David Finis, MD, Principal investigator, department of ophthalmology, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01769105     History of Changes
Other Study ID Numbers: HHUAU052012
Study First Received: January 11, 2013
Results First Received: September 1, 2014
Last Updated: October 6, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
Meibomian Gland Dysfunction
Lipiflow

ClinicalTrials.gov processed this record on October 20, 2014