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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085016
• Other study ID #: 201610044RINB
• Status: Completed
• Start date: December 8, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Meibomian Gland Dysfunction
• Meibomitis

Intervention

Device:
• Keratograph 5M, Oculus, Wetzlar, Germany

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Finis D, Ackermann P, Pischel N, König 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in meiboscore	compare change in meibography images using meiboscore system	6 months