Back to resultsEvaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
Primary Purpose
Cataract Patients
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lipiview 2
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract Patients
Eligibility Criteria
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.
Sites / Locations
- Department of Ophthalmology, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cataract patients
Arm Description
cataract patients undergoing phacoemulsification
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03276182
Brief Title
Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
Official Title
Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
May 31, 2016 (Actual)
Study Completion Date
May 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cataract patients
Arm Type
Experimental
Arm Description
cataract patients undergoing phacoemulsification
Intervention Type
Device
Intervention Name(s)
Lipiview 2
Intervention Description
Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
Primary Outcome Measure Information:
Title
the change of parameters associated with dry eye syndrome
Description
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)
Title
the change of parameters associated with meibomiangland dysfunction
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Ophthalmology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
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