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

Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery

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

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Procedure: IPL

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPL group; Subject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery	Procedure: 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.
No Intervention: Non-IPL group; Subject who do not have intense pulsed light (IPL) laser before cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TBUT	tear break-up time	3 months
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Tae-Young Chung, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 3, 2020
• Primary Completion (Anticipated): March 2, 2021
• Study Completion (Anticipated): March 2, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 2019-07-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No