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

NCT06034626 | Completed Phase 3 DMC

• 1 other identifier: 2020-210
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

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.

Conditions

MGD-Meibomian Gland Dysfunction

Keywords

MGD; IPL; Non-inferiority analysis

Outcome Measures

Primary Outcomes (5)

• SPEED Scores

  Standard Patient Evaluation of Eye Dryness questionnaire

  Baseline, 1 month, 2 months, 3 months, 4 months

• CFS scores

  corneal fluorescein staining scores

  Baseline, 1 month, 2 months, 3 months, 4 months

• TBUT

  Tear breakup time

  Baseline, 1 month, 2 months, 3 months, 4 months

• 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.

  Baseline, 1 month, 2 months, 3 months, 4 months

• 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).

  Baseline, 1 month, 2 months, 3 months, 4 months

Secondary Outcomes (2)

• BCVA

  Baseline, 4 months

• IOP

  Baseline, 4 months

Study Arms (2)

OPL-I

EXPERIMENTAL

Patients treated with OPL-I with the dual filter system

Procedure: Intense pulsed light; Drug: 0.3% hyaluronic acid eye drops

M22

ACTIVE COMPARATOR

Patients treated with OPL-I with the single filter system

Procedure: Intense pulsed light; Drug: 0.3% hyaluronic acid eye drops

Interventions

Intense pulsed light PROCEDURE

Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.

M22; OPL-I

0.3% hyaluronic acid eye drops DRUG

0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.

M22; OPL-I

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Aier Eye Hospital, Wuhan: collaborator

Study Sites (3)

Hankou Aier Eye Hospital, Wuhan，Hubei Province

Wuhan, Hubei, 430000, China

Location

Wuhan Aier Eye Hospital, Wuhan，Hubei Province

Wuhan, Hubei, 430000, China

Location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (2)

• 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.

  PMID: 25594770 BACKGROUND

• 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.

  PMID: 32452923 BACKGROUND

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Xiuming Jin, PhD

  Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients receiving IPL treatment were masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: November 3, 2020
• Primary Completion: August 10, 2021
• Study Completion: December 15, 2021
• Last Updated: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)