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

Primary Purpose

MGD-Meibomian Gland Dysfunction

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Intense pulsed light
0.3% hyaluronic acid eye drops
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MGD-Meibomian Gland Dysfunction focused on measuring MGD, IPL, Non-inferiority analysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6 Tear breakup time (TBUT) of ≤10 s in the studied eye Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s) Meibomian gland secretion score (MGSS) of ≥6 in the studied eye. Exclusion Criteria: Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment Facial IPL treatment within the prior 12 months Any surgery of the eye or eyelids within the prior six months Ocular surface and eyelid abnormalities Any systemic condition that might cause eye dryness Use of photosensitive drugs within the prior three months Precancerous lesions Skin cancer or pigmented lesions in the treatment area Overexposure to the sun within the previous month Ocular infections within the previous six months Uncontrolled infections or immunosuppressive diseases

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPL-I

M22

Arm Description

Patients treated with OPL-I with the dual filter system

Patients treated with OPL-I with the single filter system

Outcomes

Primary Outcome Measures

SPEED Scores
Standard Patient Evaluation of Eye Dryness questionnaire
CFS scores
corneal fluorescein staining scores
TBUT
Tear breakup time
MGSS
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.
MGMS
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).

Secondary Outcome Measures

BCVA
best-corrected visual acuity
IOP
intraocular pressure measurements

Full Information

First Posted
August 29, 2023
Last Updated
September 11, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Aier Eye Hospital, Wuhan
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1. Study Identification

Unique Protocol Identification Number
NCT06034626
Brief Title
Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
Acronym
MGD
Official Title
Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Aier Eye Hospital, Wuhan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MGD-Meibomian Gland Dysfunction
Keywords
MGD, IPL, Non-inferiority analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The trial aimed to assess therapeutic effectiveness of the study treatment arm (OPL-I with the dual filter system; Miracle Laser systems, Wuhan, China) to the control treatment arm (M22 with a single filter; Lumenis, Yokneam, Israel). Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Masking
Participant
Masking Description
Patients receiving IPL treatment were masked.
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPL-I
Arm Type
Experimental
Arm Description
Patients treated with OPL-I with the dual filter system
Arm Title
M22
Arm Type
Active Comparator
Arm Description
Patients treated with OPL-I with the single filter system
Intervention Type
Procedure
Intervention Name(s)
Intense pulsed light
Intervention Description
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Intervention Type
Drug
Intervention Name(s)
0.3% hyaluronic acid eye drops
Intervention Description
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
Primary Outcome Measure Information:
Title
SPEED Scores
Description
Standard Patient Evaluation of Eye Dryness questionnaire
Time Frame
Baseline, 1 month, 2 months, 3 months, 4 months
Title
CFS scores
Description
corneal fluorescein staining scores
Time Frame
Baseline, 1 month, 2 months, 3 months, 4 months
Title
TBUT
Description
Tear breakup time
Time Frame
Baseline, 1 month, 2 months, 3 months, 4 months
Title
MGSS
Description
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.
Time Frame
Baseline, 1 month, 2 months, 3 months, 4 months
Title
MGMS
Description
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).
Time Frame
Baseline, 1 month, 2 months, 3 months, 4 months
Secondary Outcome Measure Information:
Title
BCVA
Description
best-corrected visual acuity
Time Frame
Baseline, 4 months
Title
IOP
Description
intraocular pressure measurements
Time Frame
Baseline, 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fitzpatrick skin type I-IV according to sun sensitivity and skin appearance A Standard Patient Evaluation of Eye Dryness (SPEED) score of ≥6 Tear breakup time (TBUT) of ≤10 s in the studied eye Corneal fluorescein staining (CFS) score of ≥1 (it is not necessary to consider this criterion if the TBUT is ≤5 s) Meibomian gland secretion score (MGSS) of ≥6 in the studied eye. Exclusion Criteria: Use of prescription eye drops (excluding artificial tears) within 48 hours of recruitment Facial IPL treatment within the prior 12 months Any surgery of the eye or eyelids within the prior six months Ocular surface and eyelid abnormalities Any systemic condition that might cause eye dryness Use of photosensitive drugs within the prior three months Precancerous lesions Skin cancer or pigmented lesions in the treatment area Overexposure to the sun within the previous month Ocular infections within the previous six months Uncontrolled infections or immunosuppressive diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuming Jin, PhD
Organizational Affiliation
Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Director
Facility Information:
Facility Name
Hankou Aier Eye Hospital, Wuhan，Hubei Province
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Wuhan Aier Eye Hospital, Wuhan，Hubei Province
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For patients' privacy reasons
Citations:
PubMed Identifier
25594770
Citation
Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg. 2015 Jan;33(1):41-6. doi: 10.1089/pho.2014.3819.
Results Reference
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PubMed Identifier
32452923
Citation
Yan X, Hong J, Jin X, Chen W, Rong B, Feng Y, Huang X, Li J, Song W, Lin L, Cheng Y. The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial. Eye Contact Lens. 2021 Jan 1;47(1):45-53. doi: 10.1097/ICL.0000000000000711.
Results Reference
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Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction

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