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

Completed

• Conditions: Meibomitis; Meibomian Gland Dysfunction; Dyslipidemias
• Interventions: Device: Keratograph 5M, Oculus, Wetzlar, Germany

• Registration Number: NCT04085016
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12-08
• Study First Submitted: 2019-09-08
• Study First Submitted QC: 2019-09-08
• Study First Posted: 2019-09-11
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
meibography of non-statin group	Keratograph 5M, Oculus, Wetzlar, Germany	patients with recently diagnosed dyslipidemia who were eligible to undergo 3 to 6 months of lifestyle interventions before re-evaluation for starting statin therapy
meibography of statin group	Keratograph 5M, Oculus, Wetzlar, Germany	patients with regular HMG CoA reductase inhibitor (statin) treatment

Primary Outcome Measures

Name	Time	Method
change in meiboscore	6 months	compare change in meibography images using meiboscore system

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan