Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

Cataract Patients Clinical Trial

Official title:

Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276182
• Other study ID #: 4-2015-0851
• Status: Completed
• Phase: N/A
• First received: August 29, 2017
• Last updated: September 6, 2017
• Start date: October 5, 2015
• Est. completion date: May 31, 2016

Study information

• Verified date: August 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Cataract Patients

Intervention

Device:
• Lipiview 2
Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)