Back to resultsEvaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IPL/Lipiflow
IPL/MGX
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
Eligibility Criteria
Inclusion Criteria:
- patients with meibomian gland dysfunction
- patients with ocular discomfort
- skin type:FitzpatricⅠ-Ⅳ
Exclusion Criteria:
- patients with acute ocular inflammation
- eye surgery history in the last 12 months
- patients who have received IPL or Lipiflow in the last 12 months
- patients who wear contact lens in last one month
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IPL/Lipiflow
IPL/MGX
Arm Description
the group in which patients treated with IPL combined with lipiflow
the group in which patients treated with IPL combined with meibomian gland massage
Outcomes
Primary Outcome Measures
ocular surface disease index(OSDI)
The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability
meibomian gland expressibility score and meibum quality score
The score is on a scale of 0 to 6.The higher scores, the severity of the meibomian gland function(the highest score is 6 and the lowest score is 0)
meibomian gland dropout score
the higher scores, the severity of the meibomian gland morphology(The highest score is 6 and the lowest score is 0)
Breakup time
the shorter time, the poorer of the tear film stability
Secondary Outcome Measures
Full Information
NCT ID
NCT04633798
First Posted
May 20, 2020
Last Updated
November 16, 2020
Sponsor
Aier School of Ophthalmology, Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04633798
Brief Title
Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
Official Title
Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 21, 2020 (Anticipated)
Study Completion Date
December 21, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aier School of Ophthalmology, Central South University
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
To compare the effect of IPL combined with lipiflow and IPL combined with meibomian gland massage in treating meibomian gland dysfunction of different degrees ,focusing on effective rate, lasting time and changes of meibomian gland function and morphology.
Detailed Description
To divide all participants into two groups, group one treated with IPL combined with Lipiflow and group two treated with IPL combined with meibomian gland massage.The following parameters were recorded after treatment: the effective rate, lasting time and changes of meibomian gland function and morphology.All parameters were compared between the two groups.
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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPL/Lipiflow
Arm Type
Experimental
Arm Description
the group in which patients treated with IPL combined with lipiflow
Arm Title
IPL/MGX
Arm Type
Active Comparator
Arm Description
the group in which patients treated with IPL combined with meibomian gland massage
Intervention Type
Procedure
Intervention Name(s)
IPL/Lipiflow
Intervention Description
To treat patients with MGD using intense pulsed light combined with lipiflow
Intervention Type
Procedure
Intervention Name(s)
IPL/MGX
Intervention Description
To treat patients with MGD using intense pulsed light combined with meibomian gland massage
Primary Outcome Measure Information:
Title
ocular surface disease index(OSDI)
Description
The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability
Time Frame
6 months
Title
meibomian gland expressibility score and meibum quality score
Description
The score is on a scale of 0 to 6.The higher scores, the severity of the meibomian gland function(the highest score is 6 and the lowest score is 0)
Time Frame
6 months
Title
meibomian gland dropout score
Description
the higher scores, the severity of the meibomian gland morphology(The highest score is 6 and the lowest score is 0)
Time Frame
6 months
Title
Breakup time
Description
the shorter time, the poorer of the tear film stability
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with meibomian gland dysfunction
patients with ocular discomfort
skin type:FitzpatricⅠ-Ⅳ
Exclusion Criteria:
patients with acute ocular inflammation
eye surgery history in the last 12 months
patients who have received IPL or Lipiflow in the last 12 months
patients who wear contact lens in last one month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Chen, doctor
Phone
+86-021-62956699
Email
chinacy@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Chen, doctor
Organizational Affiliation
Shanghai aier eys hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
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