CClinicalTrials.gg
Status unknownNCT04633798Updated Nov 18, 2020

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

An interventional study of IPL/Lipiflow and IPL/MGX in Meibomian Gland Dysfunction, sponsored by Aier School of Ophthalmology, Central South University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-18.

Sponsored by Aier School of Ophthalmology, Central South University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Meibomian Gland Dysfunction
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with meibomian gland dysfunction
  • patients with ocular discomfort
  • skin type:FitzpatricⅠ-Ⅳ

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    IPL/Lipiflow

    the group in which patients treated with IPL combined with lipiflow

    Procedure: IPL/Lipiflow

  • Active comparator
    IPL/MGX

    the group in which patients treated with IPL combined with meibomian gland massage

    Procedure: IPL/MGX

Interventions

  • ProcedureIPL/Lipiflow

    To treat patients with MGD using intense pulsed light combined with lipiflow

  • ProcedureIPL/MGX

    To treat patients with MGD using intense pulsed light combined with meibomian gland massage

05

What researchers measure

Primary outcomes

  1. ocular surface disease index(OSDI)

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

    Time frame: 6 months

  2. 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)

    Time frame: 6 months

  3. 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)

    Time frame: 6 months

  4. Breakup time

    the shorter time, the poorer of the tear film stability

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04633798
Lead sponsor
Aier School of Ophthalmology, Central South University
Responsible party
Sponsor
First posted
Nov 18, 2020
Start date
Dec 1, 2020 (estimated)
Primary completion
Dec 21, 2020 (estimated)
Completion
Dec 21, 2020 (estimated)
Last update
Nov 18, 2020

Study contacts

Yan Chen, doctor
Contact
chinacy@hotmail.com
+86-021-62956699
Yan Chen, doctor
principal investigator · Shanghai aier eys hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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