Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study for Evaluation of LipiFlow Screening Methods|
- Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.
Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.
|Study Start Date:||September 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: LipiFlow Treatment
Treatment with LipiFlow device
Device: LipiFlow System
In-office treatment for meibomian gland dysfunction
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202747
|United States, Illinois|
|Hoffman Estates, Illinois, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Winchester, Massachusetts, United States|
|Study Director:||Christy Stevens, OD||TearScience|