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

• Sponsor: Aier School of Ophthalmology, Central South University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04633798
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Days): 20

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction	Procedure: IPL/Lipiflow; Procedure: IPL/MGX	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Efficacy of Intense Pulse Light Combined With Lipiflow in the Treatment of Meibomian Gland Dysfunction
• Anticipated Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Dec 21, 2020
• Anticipated Study Completion Date: Dec 21, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ocular surface disease index(OSDI) [6 months]

   The OSDI is assessed on a scale of 0 to 100,with higher scores representing greater disability

2. meibomian gland expressibility score and meibum quality score [6 months]

   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)

3. meibomian gland dropout score [6 months]

   the higher scores, the severity of the meibomian gland morphology(The highest score is 6 and the lowest score is 0)

4. Breakup time [6 months]

   the shorter time, the poorer of the tear film stability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aier School of Ophthalmology, Central South University

Investigators

• Principal Investigator: Yan Chen, doctor, Shanghai aier eys hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aier School of Ophthalmology, Central South University
• ClinicalTrials.gov Identifier: NCT04633798
• Other Study ID Numbers: SHAIER2020IRB04
• First Posted: Nov 18, 2020
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

No Results Posted as of Nov 18, 2020