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Clinical Trials/NCT03276182
NCT03276182CompletedNot Applicable

Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery

Yonsei University2 sites in 1 country60 target enrollmentStarted: October 5, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
the change of parameters associated with dry eye syndrome

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
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

  • 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.

Arms & Interventions

cataract patients

Experimental

cataract patients undergoing phacoemulsification

Intervention: Lipiview 2 (Device)

Outcomes

Primary Outcomes

the change of parameters associated with dry eye syndrome

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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