Meibomian Gland Dysfunction Treatment

N/ACompletedNCT04229888

Indiana University14 enrolled

Overview

The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meibomian Gland Dysfunction Dry Eye

Interventions

LipiFlowDEVICE

Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content

Light Based (Sham) TreatmentDEVICE

A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * evidence of meibomian gland obstruction in both eyes * dry eye symptoms per DEQ-5 Exclusion Criteria: * active ocular infection * previous LipiFlow treatment * beginning new oral or other systemic medications within prior 3 months * beginning new or changing dosages of ocular medications within prior 3 months * previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months * habitual contact lens wear in prior 3 months * women who are pregnant or nursing

Locations (1)

Indiana University School of Optometry

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Dry Eye Questionnaire 5 (DEQ-5) Score

DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.

Time frame: 2 weeks

Secondary Outcomes

Meibomian Gland Score

Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)

Time frame: 2 weeks

Tear Break-Up Time (TBUT)

Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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