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CompletedNCT03276182Updated Sep 8, 2017

Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

An interventional study of Lipiview 2 in Cataract Patients, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract Patients
03

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    cataract patients

    cataract patients undergoing phacoemulsification

    Device: Lipiview 2

Interventions

  • DeviceLipiview 2

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and 1 month after POD(postoperative day)

  2. 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.

    Time frame: baseline and 1 month after POD(postoperative day)

06

Study locations

1 site
  • Department of Ophthalmology, Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03276182
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
Oct 5, 2015
Primary completion
May 31, 2016
Completion
May 31, 2016
Last update
Sep 8, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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