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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04457999
Other study ID # 2019-03-011
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2020
Est. completion date July 30, 2020

Study information

Verified date July 2020
Source Samsung Medical Center
Contact Tae-Young Chung, MD. PhD
Phone 82-2-3410-3563
Email tychung@skku.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 30, 2020
Est. primary completion date July 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Intervention

Device:
Lipiflow Thermal pulsation
Single vectored thermal pulsation treatment for dry eye

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary improvement of dry eye symptom ocular dryness 1 month
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