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

NCT04085016 | Completed

• 1 other identifier: 201610044RINB
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction; Meibomitis; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• change in meiboscore

  compare change in meibography images using meiboscore system

  6 months

Study Arms (2)

meibography of statin group

patients with regular HMG CoA reductase inhibitor (statin) treatment

Device: Keratograph 5M, Oculus, Wetzlar, Germany

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

Device: Keratograph 5M, Oculus, Wetzlar, Germany

Interventions

Keratograph 5M, Oculus, Wetzlar, Germany DEVICE

meibography of non-statin group; meibography of statin group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with dyslipidemia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 23747164 BACKGROUND

• 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.

  PMID: 21450913 BACKGROUND

• 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.

  PMID: 25330304 BACKGROUND

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Meibomitis; Dyslipidemias

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Blepharitis; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• I-Jong Wang, MD,PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 11, 2019
• Study Start: December 8, 2016
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)