Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime
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 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|
- 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.
- 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.
|Study Start Date:||April 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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
Patients receive a single Lipiflow-treatment
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769105
|Deparment of ophthalmology, Heinrich-Heine-University|
|Duesseldorf, Germany, D-40225|
|Study Chair:||Gerd Geerling, M.D.||Deparmtent of ophthalmology, Heinrich-Heine-University, Duesseldorf|