Back to resultsClinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
Primary Purpose
Dry Eye
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lipiflow Thermal pulsation
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Patients older than 21, who will get catarct surgeyr
- Patients whose visual acuity anticipated better than 20/25 after surgery
- Patients with informed consent
- Patients with meibomian gland dysfunction
Exclusion Criteria:
- ocular injury, active injection
- uncontrolled systemic disease
- Contact lens wear within 1 month
- Allergic to fluorescein sodium or topical anesthetics
- ocular surgery or trauma within 6 months
- disorder of lid anatomy
- other reason for decreased vision other than cataract
- anticipated visual acuity less than 20/25
- Patients less than 20 years.
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lipiflow treatment
Arm Description
Lipiflow thermal pulsation prior to cataract surgery
Outcomes
Primary Outcome Measures
improvement of dry eye symptom
ocular dryness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457999
Brief Title
Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
Official Title
Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
July 2, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lipiflow treatment
Arm Type
Experimental
Arm Description
Lipiflow thermal pulsation prior to cataract surgery
Intervention Type
Device
Intervention Name(s)
Lipiflow Thermal pulsation
Intervention Description
Single vectored thermal pulsation treatment for dry eye
Primary Outcome Measure Information:
Title
improvement of dry eye symptom
Description
ocular dryness
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients older than 21, who will get catarct surgeyr
Patients whose visual acuity anticipated better than 20/25 after surgery
Patients with informed consent
Patients with meibomian gland dysfunction
Exclusion Criteria:
ocular injury, active injection
uncontrolled systemic disease
Contact lens wear within 1 month
Allergic to fluorescein sodium or topical anesthetics
ocular surgery or trauma within 6 months
disorder of lid anatomy
other reason for decreased vision other than cataract
anticipated visual acuity less than 20/25
Patients less than 20 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Young Chung, MD. PhD
Phone
82-2-3410-3563
Email
tychung@skku.edu
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Young Chung
Phone
+82-10-9933-3563
Email
tychung@skku.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
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