Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2020
CompletedNovember 18, 2020
November 1, 2020
20 days
May 20, 2020
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
ocular surface disease index(OSDI)
The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability
6 months
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)
6 months
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)
6 months
Breakup time
the shorter time, the poorer of the tear film stability
6 months
Study Arms (2)
IPL/Lipiflow
EXPERIMENTALthe group in which patients treated with IPL combined with lipiflow
IPL/MGX
ACTIVE COMPARATORthe group in which patients treated with IPL combined with meibomian gland massage
Interventions
To treat patients with MGD using intense pulsed light combined with lipiflow
To treat patients with MGD using intense pulsed light combined with meibomian gland massage
Eligibility Criteria
You may qualify if:
- patients with meibomian gland dysfunction
- patients with ocular discomfort
- skin type:FitzpatricⅠ-Ⅳ
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Chen, doctor
Shanghai aier eys hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
November 18, 2020
Study Start
December 1, 2020
Primary Completion
December 21, 2020
Study Completion
December 21, 2020
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share