Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction (MGD)

September 11, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
This study aimed to determine the therapeutic effectiveness of different machines in intense pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with MGD underwent three sessions of IPL treatment in a control (M22) treatment group or experimental (OPL-I) treatment group and were followed up three to four weeks after each session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at baseline and follow-up visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Hankou Aier Eye Hospital, Wuhan，Hubei Province
      • Wuhan, Hubei, China, 430000
        • Wuhan Aier Eye Hospital, Wuhan，Hubei Province
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance
  2. A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6
  3. Tear breakup time (TBUT) of ≤10 s in the studied eye
  4. Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s)
  5. Meibomian gland secretion score (MGSS) of ≥6 in the studied eye.

Exclusion Criteria:

  1. Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment
  2. Facial IPL treatment within the prior 12 months
  3. Any surgery of the eye or eyelids within the prior six months
  4. Ocular surface and eyelid abnormalities
  5. Any systemic condition that might cause eye dryness
  6. Use of photosensitive drugs within the prior three months
  7. Precancerous lesions
  8. Skin cancer or pigmented lesions in the treatment area
  9. Overexposure to the sun within the previous month
  10. Ocular infections within the previous six months
  11. Uncontrolled infections or immunosuppressive diseases

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OPL-I
Patients treated with OPL-I with the dual filter system
Procedure: Intense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Drug: 0.3% hyaluronic acid eye drops
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
Active Comparator: M22
Patients treated with OPL-I with the single filter system
Procedure: Intense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Drug: 0.3% hyaluronic acid eye drops
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPEED Scores
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months
Standard Patient Evaluation of Eye Dryness questionnaire
Baseline, 1 month, 2 months, 3 months, 4 months
CFS scores
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months
corneal fluorescein staining scores
Baseline, 1 month, 2 months, 3 months, 4 months
TBUT
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months
Tear breakup time
Baseline, 1 month, 2 months, 3 months, 4 months
MGSS
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months
Meibomian gland secretion scores. The MGSS evaluates the obstruction of meibum along the lower eyelid. Three positions along the lower eyelid were detected (five nasal, five central, and five temporal meibomian glands). A score of 0 indicated secretion by all five glands, a score of 1 indicated secretion by three to four glands, a score of 2 indicated secretion by one or two glands, and a score of 3 indicated no secretion by any glands.
Baseline, 1 month, 2 months, 3 months, 4 months
MGMS
Time Frame: Baseline, 1 month, 2 months, 3 months, 4 months
meibomian gland meibum scores. The MGMS evaluates the quality of meibum along the lower eyelid, with a score of 0 indicating clear liquid meibum, a score of 1 indicating cloudy liquid meibum, a score of 2 indicating cloudy granular meibum, and a score of 3 indicating toothpaste-like solid meibum).
Baseline, 1 month, 2 months, 3 months, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA
Time Frame: Baseline, 4 months
best-corrected visual acuity
Baseline, 4 months
IOP
Time Frame: Baseline, 4 months
intraocular pressure measurements
Baseline, 4 months

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Aier Eye Hospital, Wuhan

Investigators

  • Study Director: Xiuming Jin, PhD, Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 3, 2020

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For patients' privacy reasons

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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