Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland

November 12, 2020 updated by: Yune Zhao
200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously untreated patients with xerophthalmia

Exclusion Criteria:

  • No history of ocular surgery and trauma
  • Any eye diseases except xerophthalmia
  • No treated for xerophthalmia before
  • Successful completion of follow-ups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intense pulsed light therapy group
Device: Intense pulsed light therapy
Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.
EXPERIMENTAL: Hot compress massage group
Other: Hot compress massage
Patients with xerophthalmia were treated with hot compress massage of meibomian gland.
EXPERIMENTAL: Intense pulsed light therapy and hot compress massage group
Device: Intense pulsed light therapy
Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.
Other: Hot compress massage
Patients with xerophthalmia were treated with hot compress massage of meibomian gland.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of meibomian glands after the treatment.
Time Frame: up to 2 months
Length in millimeters.
up to 2 months
The area of meibomian glands after the treatment.
Time Frame: up to 2 months
Area in millimeters^2.
up to 2 months
The percentage of meibomian glands after the treatment.
Time Frame: up to 2 months
Percentage of meibomian glands in %(area of meibomian glands (mm^2) and area of palpebral conjunctiva (mm^2) will be combined to report percentage of meibomian glands in %) are used to assess this outcome measure.
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yune Zhao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

January 31, 2021

Study Completion (ANTICIPATED)

January 31, 2021

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (ACTUAL)

November 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LXY-meibomian gland

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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