Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction

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.

Study Overview

• Status: Unknown
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: Procedure: IPL/Lipiflow; Procedure: IPL/MGX

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IPL/Lipiflow; the group in which patients treated with IPL combined with lipiflow	Procedure: IPL/Lipiflow; To treat patients with MGD using intense pulsed light combined with lipiflow
Active Comparator: IPL/MGX; the group in which patients treated with IPL combined with meibomian gland massage	Procedure: IPL/MGX; To treat patients with MGD using intense pulsed light combined with meibomian gland massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aier School of Ophthalmology, Central South University
• Investigators: Principal Investigator: Yan Chen, doctor, Shanghai aier eys hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 21, 2020
• Study Completion (Anticipated): December 21, 2020

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: SHAIER2020IRB04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No