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

Not Applicable

Completed

• Conditions: Meibomian Gland Dysfunction

• Registration Number: NCT03950115
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Enrolled patients are going to be randomly assigned to two groups. All of the patients will undergo four treatment sessions in total, which are two weeks apart. Group 1 will undergo two sessions of intense pulsed light therapy with meibomian gland expression, as well as two sessions of intense pulsed light alone. Group 2 will receive two sessions of intense pulsed light therapy alone, and two sessions of intense pulsed light therapy with meibomian gland expression. The following parameters will be measured at baseline, 2 weeks after the second treatment session, and 2 weeks after the fourth treatment session: tearfilm break-up time, Oxford grade for corneal staining, meibomian gland expressibility, meibum quality, and ocular surface disease index.

Study Timeline

• Study Start: 2019-04-18
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-12
• Study First Posted: 2019-05-15
• Primary Completion: 2020-02-18
• Study Completion: 2020-04-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Clinical diagnosis of meibomian gland dysfunction

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 ocular surface disease index at 2 weeks after the last treatment session	Baseline and 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.
Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session	Baseline and 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)
Change from baseline meibum quality score at 2 weeks after the last treatment session	Baseline and 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)
Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session	Baseline and 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)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of