Clinical trial NCT06034626: Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
Official title: Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: MGD-Meibomian Gland Dysfunction
Keywords: MGD
IPL
Non-inferiority analysis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Aier Eye Hospital, Wuhan
First posted: 2023-09-13
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: SPEED Scores
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months
measure: CFS scores
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months
measure: TBUT
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months
measure: MGSS
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months
measure: MGMS
timeFrame: Baseline, 1 month, 2 months, 3 months, 4 months
Secondary outcomes:
measure: BCVA
timeFrame: Baseline, 4 months
measure: IOP
timeFrame: Baseline, 4 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hankou Aier Eye Hospital, Wuhan，Hubei Province
state: Hubei
city: Wuhan
country: China
facility: Wuhan Aier Eye Hospital, Wuhan，Hubei Province
state: Hubei
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Eye Center of the 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Xiuming Jin, PhD
role: STUDY_DIRECTOR
References:
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.
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.