Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction

NCT ID: NCT02618304

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-20

Study Completion Date

2016-02-19

Brief Summary

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In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.

Detailed Description

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Conditions

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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moderate to severe meibomian gland dysfunction

Group Type EXPERIMENTAL

Treatment of Meibomian gland dysfunction

Intervention Type DRUG

artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.

Interventions

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Treatment of Meibomian gland dysfunction

artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. age over 19 years old, with moderate to severe Meibomian gland dysfunction.

Exclusion Criteria

1. patients with history of previous ocular or intraocular surgery
2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease
3. history of intolerance or hypersensitivity to any component of the study medications
4. wearing contact lenses during the study period, presence of current punctal occlusion
5. pregnancy, lactating women, and children
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Ophthalmology, Yonsei Univeristy College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, Lemp MA, Nichols KK. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2065-85. doi: 10.1167/iovs.10-6997h. Print 2011 Mar. No abstract available.

Reference Type BACKGROUND
PMID: 21450920 (View on PubMed)

Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.

Reference Type BACKGROUND
PMID: 21450919 (View on PubMed)

Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.

Reference Type BACKGROUND
PMID: 21450918 (View on PubMed)

McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. doi: 10.1016/s0014-4835(03)00203-3.

Reference Type BACKGROUND
PMID: 15106913 (View on PubMed)

Other Identifiers

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1-2015-0012

Identifier Type: -

Identifier Source: org_study_id

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