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

Phase 3

Completed

• Conditions: MGD-Meibomian Gland Dysfunction
• Interventions: Procedure: Intense pulsed light; Drug: 0.3% hyaluronic acid eye drops

• Registration Number: NCT06034626
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-03
• Primary Completion: 2021-08-10
• Study Completion: 2021-12-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M22	Intense pulsed light	Patients treated with OPL-I with the single filter system
OPL-I	Intense pulsed light	Patients treated with OPL-I with the dual filter system
OPL-I	0.3% hyaluronic acid eye drops	Patients treated with OPL-I with the dual filter system
M22	0.3% hyaluronic acid eye drops	Patients treated with OPL-I with the single filter system

Primary Outcome Measures

Name	Time	Method
MGSS	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.
CFS scores	Baseline, 1 month, 2 months, 3 months, 4 months	corneal fluorescein staining scores
TBUT	Baseline, 1 month, 2 months, 3 months, 4 months	Tear breakup time
SPEED Scores	Baseline, 1 month, 2 months, 3 months, 4 months	Standard Patient Evaluation of Eye Dryness questionnaire
MGMS	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 Outcome Measures

Name	Time	Method
BCVA	Baseline, 4 months	best-corrected visual acuity
IOP	Baseline, 4 months	intraocular pressure measurements

Trial Locations

Locations (3)

Wuhan Aier Eye Hospital, Wuhan，Hubei Province; 🇨🇳 Wuhan, Hubei, China

Hankou Aier Eye Hospital, Wuhan，Hubei Province; 🇨🇳 Wuhan, Hubei, China

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China