Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intense Pulsed Light (IPL)
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
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)
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline tearfilm break-up time at 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)
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)
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03950115
Brief Title
Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
Official Title
Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
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
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intense Pulsed Light (IPL)
Other Intervention Name(s)
Meibomian gland expression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline tearfilm break-up time at 2 weeks after the last treatment session
Time Frame
Baseline and 2 weeks after the last treatment session
Title
Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session
Description
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)
Time Frame
Baseline and 2 weeks after the last treatment session
Title
Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session
Description
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)
Time Frame
Baseline and 2 weeks after the last treatment session
Title
Change from baseline meibum quality score at 2 weeks after the last treatment session
Description
The meibum quality score were divided into the following four degrees: 0 (clear), 1 (cloudy), 2 (granular), and 3 (toothpaste)
Time Frame
Baseline and 2 weeks after the last treatment session
Title
Change from baseline ocular surface disease index at 2 weeks after the last treatment session
Description
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.
Time Frame
Baseline and 2 weeks after the last treatment session
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
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