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

Primary Purpose

Dry Eye Syndromes

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IPL
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

IPL group

Non-IPL group

Arm Description

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

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

Outcomes

Primary Outcome Measures

TBUT
tear break-up time
meibomian gland function score
By expression of eyelid, scoring of expressibility and quality of meibum will be tested. Form of secretion predominantly secreted by the eight meibomian glands in the center of the lid was evaluated as follows. grade 0, clear meibum is easily expressed; grade 1, cloudy meibum is expressed with mild pressure; grade 2, cloudy meibum is expressed with more than moderate pressure; and grade 3, meibum cannot be expressed even with the hard pressure. Higher score means a worst outcome.

Secondary Outcome Measures

OSDI
questionnaire to evaluate dry eye symptoms. OSDI grading (0 ~ 100) was as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). Higher score means a worse outcome.
Corneal staining score
Punctate epithelial erosion of cornea will be evaluated with standard classification system(NEI score, National Eye Institute score). It divides the cornea into five sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points. Higher score means a worse outcome.

Full Information

First Posted
May 15, 2020
Last Updated
May 9, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04391907
Brief Title
Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient
Official Title
Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the covid 19, patient recruiment is not going smoothly, so the study was canceled.
Study Start Date
March 3, 2020 (Anticipated)
Primary Completion Date
March 2, 2021 (Anticipated)
Study Completion Date
March 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPL group
Arm Type
Active Comparator
Arm Description
Subject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery
Arm Title
Non-IPL group
Arm Type
No Intervention
Arm Description
Subject who do not have intense pulsed light (IPL) laser before cataract surgery
Intervention Type
Procedure
Intervention Name(s)
IPL
Intervention Description
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.
Primary Outcome Measure Information:
Title
TBUT
Description
tear break-up time
Time Frame
3 months
Title
meibomian gland function score
Description
By expression of eyelid, scoring of expressibility and quality of meibum will be tested. Form of secretion predominantly secreted by the eight meibomian glands in the center of the lid was evaluated as follows. grade 0, clear meibum is easily expressed; grade 1, cloudy meibum is expressed with mild pressure; grade 2, cloudy meibum is expressed with more than moderate pressure; and grade 3, meibum cannot be expressed even with the hard pressure. Higher score means a worst outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
OSDI
Description
questionnaire to evaluate dry eye symptoms. OSDI grading (0 ~ 100) was as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). Higher score means a worse outcome.
Time Frame
3 months
Title
Corneal staining score
Description
Punctate epithelial erosion of cornea will be evaluated with standard classification system(NEI score, National Eye Institute score). It divides the cornea into five sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points. Higher score means a worse outcome.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A patient at the age of 21 cataract surgery A patient has the visual potential of 20/25 or better in each eye after cataract removal Dry eye patient by meibomian gland dysfunction Written informed consent to surgery and participation in the study Exclusion Criteria: Eye damage, active eye infection Uncontrolled health problem Wear contact lens within one month Allergic reactions of fluorescein sodium or ophtalmic anesthetic Eye surgery and trauma in the last six months Eye disease, structural abnormality If there is a cause of vision loss other than cataracts Under 20/25 expect vision Under the age of 20 years of age Pregnant woman and lactating woman Medical conditions in which IPL is contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Young Chung, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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