Effect of HMG-CoA Reductase Inhibitors on the Meibomian Gland Morphology in Patients With Meibomitis

NCT ID: NCT04085016

Last Updated: 2020-10-14

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

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-08

Study Completion Date

2020-01-31

Brief Summary

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This study intends to evaluate the relationship between meibomitis and statin use. Meibomitis is the predominant cause of evaporative dry eye. Higher cholesterol levels were noted in patients with meibomitis when compared to controls without meibomitis. We would like to investigate the effect of statin use on meibomitis among patients with dyslipidemia.

Detailed Description

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The purpose of our study is to assess the change of meibomian gland structure in patients during treatment with 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors using meibography. Patients with dyslipidemia with or without HMG-CoA reductase inhibitor (statin) treatment were recruited. Medical records are collected prospectively from Dec. 8th 2016 to Dec. 31st 2019. Meibomian gland (MG) morphology described by meiboscores, lid margin abnormality scores, meibum quality, and dry eye parameters were compared between the two groups. This study may also provide information about possible treatment options in patients with meibomitis in the future.

Conditions

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Meibomian Gland Dysfunction Meibomitis Dyslipidemias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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meibography of statin group

patients with regular HMG CoA reductase inhibitor (statin) treatment

Keratograph 5M, Oculus, Wetzlar, Germany

Intervention Type DEVICE

meibography of non-statin group

patients with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy

Keratograph 5M, Oculus, Wetzlar, Germany

Intervention Type DEVICE

Interventions

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Keratograph 5M, Oculus, Wetzlar, Germany

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with regular HMGCR inhibitor (statin) treatment, and those with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy

Exclusion Criteria

* patients with active eye infection, previous history of chemical or thermal injury to ocular surface, previous operation history of eyelid or conjunctiva, any known allergy or contraindications to statins, history of percutaneous coronary intervention, cerevascular accident, acute coronary syndrome, or rheumatological diseases, fish oil supplements or pregnancy were excluded
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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I-Jong Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Pinna A, Blasetti F, Zinellu A, Carru C, Solinas G. Meibomian gland dysfunction and hypercholesterolemia. Ophthalmology. 2013 Dec;120(12):2385-2389. doi: 10.1016/j.ophtha.2013.05.002. Epub 2013 Jun 6.

Reference Type BACKGROUND
PMID: 23747164 (View on PubMed)

Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1922-9. doi: 10.1167/iovs.10-6997a. No abstract available.

Reference Type BACKGROUND
PMID: 21450913 (View on PubMed)

Finis D, Ackermann P, Pischel N, Konig C, Hayajneh J, Borrelli M, Schrader S, Geerling G. Evaluation of Meibomian Gland Dysfunction and Local Distribution of Meibomian Gland Atrophy by Non-contact Infrared Meibography. Curr Eye Res. 2015;40(10):982-9. doi: 10.3109/02713683.2014.971929. Epub 2014 Oct 20.

Reference Type BACKGROUND
PMID: 25330304 (View on PubMed)

Other Identifiers

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201610044RINB

Identifier Type: -

Identifier Source: org_study_id

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