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

July 1, 2020 updated by: tae-young chung, Samsung Medical Center
To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lipiflow treatment
Lipiflow thermal pulsation prior to cataract surgery
Device: Lipiflow Thermal pulsation
Single vectored thermal pulsation treatment for dry eye

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2020

Primary Completion (ANTICIPATED)

July 2, 2020

Study Completion (ANTICIPATED)

July 30, 2020

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (ACTUAL)

July 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-03-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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