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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03950115
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.8
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Device: Intense Pulsed Light (IPL)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
• Actual Study Start Date: Apr 18, 2019
• Actual Primary Completion Date: Feb 18, 2020
• Actual Study Completion Date: Apr 10, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Group 1 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); 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.; Other Names: Meibomian gland expression

Outcome Measures

Primary Outcome Measures

1. Change from baseline tearfilm break-up time at 2 weeks after the last treatment session [Baseline and 2 weeks after the last treatment session]

2. 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)

3. 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)

4. 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)

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: tae-young chung, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03950115
• Other Study ID Numbers: 2019-04-066
• First Posted: May 15, 2019
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

No Results Posted as of May 13, 2022