Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- MGSS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients receiving IPL treatment were masked.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
OPL-I
Patients treated with OPL-I with the dual filter system
干预措施: Intense pulsed light (Procedure)
OPL-I
Patients treated with OPL-I with the dual filter system
干预措施: 0.3% hyaluronic acid eye drops (Drug)
M22
Patients treated with OPL-I with the single filter system
干预措施: Intense pulsed light (Procedure)
M22
Patients treated with OPL-I with the single filter system
干预措施: 0.3% hyaluronic acid eye drops (Drug)
结局指标
主要结局
MGSS
时间窗: 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
时间窗: Baseline, 1 month, 2 months, 3 months, 4 months
corneal fluorescein staining scores
TBUT
时间窗: Baseline, 1 month, 2 months, 3 months, 4 months
Tear breakup time
SPEED Scores
时间窗: Baseline, 1 month, 2 months, 3 months, 4 months
Standard Patient Evaluation of Eye Dryness questionnaire
MGMS
时间窗: 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).
次要结局
- BCVA(Baseline, 4 months)
- IOP(Baseline, 4 months)