Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient

NCT ID: NCT04391907

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2021-03-02

Brief Summary

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Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.

Detailed Description

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IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome after cataract surgery.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IPL group

Subject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery

Group Type ACTIVE_COMPARATOR

IPL

Intervention Type PROCEDURE

Intense pulse light (IPL) laser is used for the treatment of dry eye originated from meibomian gland dysfunction. IPL laser will be performed to patients who are planned to cataract surgery to improve dry eye.

Non-IPL group

Subject who do not have intense pulsed light (IPL) laser before cataract surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IPL

Intense pulse light (IPL) laser is used for the treatment of dry eye originated from meibomian gland dysfunction. IPL laser will be performed to patients who are planned to cataract surgery to improve dry eye.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. A patient at the age of 21 cataract surgery
2. A patient has the visual potential of 20/25 or better in each eye after cataract removal
3. Dry eye patient by meibomian gland dysfunction
4. Written informed consent to surgery and participation in the study

Exclusion Criteria

1. Eye damage, active eye infection
2. Uncontrolled health problem
3. Wear contact lens within one month
4. Allergic reactions of fluorescein sodium or ophtalmic anesthetic
5. Eye surgery and trauma in the last six months
6. Eye disease, structural abnormality
7. If there is a cause of vision loss other than cataracts
8. Under 20/25 expect vision
9. Under the age of 20 years of age
10. Pregnant woman and lactating woman
11. Medical conditions in which IPL is contraindicated
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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tae-young chung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Young Chung, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2019-07-016

Identifier Type: -

Identifier Source: org_study_id

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