Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract Patients
• Interventions: Device: Lipiview 2

• Registration Number: NCT03276182
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-05
• Primary Completion: 2016-05-31
• Study Completion: 2016-05-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cataract patients	Lipiview 2	cataract patients undergoing phacoemulsification

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of