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

NCT01769105 | Completed Results

• 1 other identifier: HHUAU052012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Meibomian Gland Dysfunction; Lipiflow

Outcome Measures

Primary Outcomes (1)

• Change of Dry Eye Symptoms

  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.

  after 3 month compared to baseline value

Secondary Outcomes (4)

• Change of Break-up-time

  after 3 month compared to baseline value

• Change in Tear Film Osmolarity

  after 3 month compared to baseline value

• Change in Lipid Layer Thickness

  after 3 month compared to baseline value

• Change in Expressible Meibomian Glands

  after 3 month compared to baseline value

Study Arms (2)

Standard Lid Hygiene Regime

ACTIVE COMPARATOR

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

Behavioral: Lid hygiene regime

Lipiflow

ACTIVE COMPARATOR

Patients receive a singe Lipiflow-treatment

Device: Lipiflow

Interventions

Lipiflow DEVICE

Patients receive a single Lipiflow-treatment

Lipiflow

Lid hygiene regime BEHAVIORAL

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

Standard Lid Hygiene Regime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Deparment of ophthalmology, Heinrich-Heine-University

Düsseldorf, D-40225, Germany

Location

Related Publications (1)

• Finis D, Hayajneh J, Konig C, Borrelli M, Schrader S, Geerling G. Evaluation of an automated thermodynamic treatment (LipiFlow(R)) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial. Ocul Surf. 2014 Apr;12(2):146-54. doi: 10.1016/j.jtos.2013.12.001. Epub 2014 Jan 22.

  PMID: 24725326 RESULT

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Limitations and Caveats

For further information please have a look at Finis et al: Evaluation of an automated thermodynamic treatment (LipiFlow®) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial.Ocul Surf. 2014 Apr;12(2):146-54.

Results Point of Contact

• Title: Dr. David Finis
• Organization: Department of ophthalmology, University of Duesseldorf

David.Finis@med.uni-duesseldorf.de

+49 211 8117320

Study Officials

• Gerd Geerling, M.D.

  Deparmtent of ophthalmology, Heinrich-Heine-University, Duesseldorf

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, department of ophthalmology

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 16, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 7, 2014
• Results First Posted: October 7, 2014

Record last verified: 2014-10

Locations

DE (1)