Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction

NCT03950115 | Completed

• 1 other identifier: 2019-04-066
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are going to Investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (5)

• Change from baseline tearfilm break-up time at 2 weeks after the last treatment session

  Baseline and 2 weeks after the last treatment session

• Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session

  Oxford grade for staining was assessed on a scale of 0 to 5. It was scaled according to the degree of corneal staining as follow: 0 (absent), 1 (minimal), 2 (mild), 3 (moderate), 4 (marked), and 5 (severe)

  Baseline and 2 weeks after the last treatment session

• Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session

  The meibomian gland expressibility was assessed on a scale of 0 to 3 in five glands on the central lower lid. It was scaled according to the number of glands expressible, as follows: 0 (all glands), 1 (three to four glands), 2 (one to two glands) and 3 (no glands)

  Baseline and 2 weeks after the last treatment session

• Change from baseline meibum quality score at 2 weeks after the last treatment session

  The meibum quality score were divided into the following four degrees: 0 (clear), 1 (cloudy), 2 (granular), and 3 (toothpaste)

  Baseline and 2 weeks after the last treatment session

• Change from baseline ocular surface disease index at 2 weeks after the last treatment session

  The ocular surface diseases index score range from 0 to 100 based on the result of standardized ocular surface disease index questionnaire. Higher value represent worse subjective symptom.

  Baseline and 2 weeks after the last treatment session

Study Arms (1)

Group 1

EXPERIMENTAL

IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading.

Device: Intense Pulsed Light (IPL)

Interventions

Intense Pulsed Light (IPL) DEVICE

IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading.

Also known as: Meibomian gland expression

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of meibomian gland dysfunction

You may not qualify if:

• Medical conditions in which IPL is contraindicated (pregnancy, breastfeeding, lupus, and any major uncontrolled health problem).
• Contact lens wearer
• Previous ocular surgery
• Previous thermal treatment for dry eye disease (e.g. LipiFlow)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

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: Professor

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 15, 2019
• Study Start: April 18, 2019
• Primary Completion: February 18, 2020
• Study Completion: April 10, 2020
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)