NCT04457999

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 1, 2020

Last Update Submit

July 1, 2020

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • improvement of dry eye symptom

    ocular dryness

    1 month

Study Arms (1)

Lipiflow treatment

EXPERIMENTAL

Lipiflow thermal pulsation prior to cataract surgery

Device: Lipiflow Thermal pulsation

Interventions

Lipiflow Thermal pulsationDEVICE

Single vectored thermal pulsation treatment for dry eye

Lipiflow treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Central Study Contacts

Tae-Young Chung, MD. PhD

CONTACT

82-2-3410-3563tychung@skku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Ph.D

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

March 20, 2020

Primary Completion

July 2, 2020

Study Completion

July 30, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)