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Completed

NCT Number: NCT04085016

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keratograph 5M, Oculus, Wetzlar, Germany

Device

Primary outcomes

  1. change in meiboscore

    Time frame: 6 months

    compare change in meibography images using meiboscore system

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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