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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04085016
Collaborator
(none)
98
1
37.7
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Keratograph 5M, Oculus, Wetzlar, Germany

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 Design

Study Type:
Observational
Actual Enrollment :
98 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of HMG-CoA Reductase Inhibitors on the Meibomian Gland Morphology in Patients With Meibomitis
Actual Study Start Date :
Dec 8, 2016
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. change in meiboscore [6 months]

    compare change in meibography images using meiboscore system

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: I-Jong Wang, MD,PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT04085016
Other Study ID Numbers:
  • 201610044RINB
First Posted:
Sep 11, 2019
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020