Clinical Outcome of Lipiflow Treatment Prior to Cataract... | NCT04457999

Studies
Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients

NCT04457999

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jul 7, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Lipiflow Thermal pulsation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2020Actual

Primary Completion Date

Jul 2, 2020Estimated

Completion Date

Jul 30, 2020Estimated

First Submitted Date

Jul 1, 2020

First Submission Date that Met QC Criteria

Jul 1, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lipiflow treatment	Experimental	Lipiflow thermal pulsation prior to cataract surgery	Device: Lipiflow Thermal pulsation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lipiflow Thermal pulsation	Device	Single vectored thermal pulsation treatment for dry eye	Lipiflow treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement of dry eye symptom	ocular dryness	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-Young Chung, MD. PhD	Contact	82-2-3410-3563		tychung@skku.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided