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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04633798
• Other study ID #: SHAIER2020IRB04
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: November 2020
• Source: Aier School of Ophthalmology, Central South University
• Contact: Yan Chen, doctor
• Phone: +86-021-62956699
• Email: chinacy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with meibomian gland dysfunction
• patients with ocular discomfort
• skin type:Fitzpatric?-?

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Procedure:
• IPL/Lipiflow
To treat patients with MGD using intense pulsed light combined with lipiflow
• IPL/MGX
To treat patients with MGD using intense pulsed light combined with meibomian gland massage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocular surface disease index(OSDI)	The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability	6 months
Primary	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
Primary	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
Primary	Breakup time	the shorter time, the poorer of the tear film stability	6 months