N/A
N=35
Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime
Meibomian Gland Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01769105 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Change of Dry Eye Symptoms — 40.1; 46.2; 39.7; 15.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lipiflow (Device); Lid hygiene regime (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Dry Eye Symptoms |
40.1; 46.2; 39.7; 15.9; 16.8; 14.7 | — |
| SECONDARY Change of Break-up-time |
7.7; 7.9; 6.7; 7.5; 9.9; 7.3 | — |
| SECONDARY Change in Tear Film Osmolarity |
296.7; 301.5; 305.0; 303.7; 307.1; 310.0 | — |
| SECONDARY Change in Lipid Layer Thickness |
44.1; 43.4; 45.8; 46.4; 47.4; 59.2 | — |
| SECONDARY Change in Expressible Meibomian Glands |
2.1; 2.5; 4.1; 4.6; 5.5; 5.8 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01769105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.