Skip to main content
OpenTrials
Completed

NCT Number: NCT06034626

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

MGD-Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hankou Aier Eye Hospital, Wuhan，Hubei Province, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. SPEED Scores

    Time frame: Baseline, 1 month, 2 months, 3 months, 4 months

    Standard Patient Evaluation of Eye Dryness questionnaire

  2. CFS scores

    Time frame: Baseline, 1 month, 2 months, 3 months, 4 months

    corneal fluorescein staining scores

  3. TBUT

    Time frame: Baseline, 1 month, 2 months, 3 months, 4 months

    Tear breakup time

  4. 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.

  5. 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).

Secondary outcomes

  1. BCVA

    Time frame: Baseline, 4 months

    best-corrected visual acuity

  2. IOP

    Time frame: Baseline, 4 months

    intraocular pressure measurements

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Aier Eye Hospital, Wuhan

Registry information

Acronym: MGD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.