Meibomian Gland Dysfunction Management

N/AActive Not RecruitingNCT03652337

University of the Incarnate Word60 enrolled

Overview

The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Contact Lens Discomfort Meibomian Gland Dysfunction

Interventions

BlephExDEVICE

Electronic lid margin debridement

Manual debridementDEVICE

Manual lid margin debridement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis. Exclusion Criteria: * Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation. * Subjects who have active ocular infections will be excluded from participation.

Locations (1)

Rosenberg School of Optometry

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Symptomatic relief

Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).

Time frame: 60 days

Secondary Outcomes

Meibography

Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.

Time frame: 60 days

Lissamine green staining grade of the lid margin

The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin.

Time frame: 60 days

Inflammatory activity

The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid.

Time frame: 60 days

Tear break-up time

Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.

Time frame: 60 days

Data from ClinicalTrials.gov

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