MGD-Meibomian Gland Dysfunction
Conditions
Keywords
MGD, IPL, Non-inferiority analysis
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.
Interventions
PROCEDUREIntense pulsed light
Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
DRUG0.3% hyaluronic acid eye drops
0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
Sponsors
Aier Eye Hospital, Wuhan
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients receiving IPL treatment were masked.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CFS scores | Baseline, 1 month, 2 months, 3 months, 4 months | corneal fluorescein staining scores |
| 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. |
| 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). |
| SPEED Scores | Baseline, 1 month, 2 months, 3 months, 4 months | Standard Patient Evaluation of Eye Dryness questionnaire |
| TBUT | Baseline, 1 month, 2 months, 3 months, 4 months | Tear breakup time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP | Baseline, 4 months | intraocular pressure measurements |
| BCVA | Baseline, 4 months | best-corrected visual acuity |
Countries
China
Outcome results
None listed