Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including parameters of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality, meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.

Study Overview

• Status: Completed
• Conditions: Cataract Patients
• Intervention / Treatment: Device: Lipiview 2

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Ophthalmology, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with cataract surgery planning with phacoemulsification and intraocular lens implantation with or without mild dry eye syndrome

Exclusion Criteria:

• the previous use of eye drops, except artificial tears within 3 months before cataract surgery
• a history of previous ocular surgery or trauma
• the presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema, and any surgical complications including rupture of the posterior capsule during cataract surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cataract patients; cataract patients undergoing phacoemulsification	Device: Lipiview 2; Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of parameters associated with dry eye syndrome	Analysis the change of parameters associated with dry eye syndrome before and after cataract surgery measured by lipiview 2.	baseline and 1 month after POD(postoperative day)
the change of parameters associated with meibomiangland dysfunction	Analysis the change of parameters associated with meibomiangland dysfunction before and after cataract surgery measured by lipiview 2.	baseline and 1 month after POD(postoperative day)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): May 31, 2016

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Eyelid Diseases; Cataract; Meibomian Gland Dysfunction; Capsule Opacification
• Other Study ID Numbers: 4-2015-0851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No