A Prospective, Randomized Comparison of Thermal Pulsation Versus Warm Compress Treatment for Signs and Symptoms of Meibomian Gland Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Change in MGS score for the worse eye
研究概览
简要总结
This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks.
详细描述
This prospective, single-center, single-masked, randomized, controlled clinical trial compared the Systane iLux handheld thermal pulsation system with a warm compress mask (Bruder Moist Heat Eye Compress, Bruder Healthcare, Alpharetta, GA, USA) for the treatment of meibomian gland dysfunction (MGD).
Subjects aged 18 or older were randomized 1:1 to either a single in-office thermal pulsation treatment or twice-daily use of the warm compress mask, with both eyes undergoing the same treatment. Enrollment criteria included Ocular Surface Disease Index (OSDI) score >23, total meibomian gland secretion (MGS) score < or =12 in the lower lid of each eye, and tear break-up time (TBUT) < 10 seconds. TBUT, MGS, and corneal staining scores were evaluated at baseline, 2 weeks, and 8 weeks. Symptoms were evaluated using the OSDI questionnaire at baseline, 2 weeks, and 8 weeks.
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 (Outcomes Assessor)
盲法说明
The clinician evaluating MGS score was masked to subject treatment assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of self-reported dry eye symptoms for 3 months prior to study enrollment
- •baseline OSDI score of 23 or greater (
- •MGS score of 12 ior less in the lower eyelid of each eye
- •TBUT <10 seconds
- •willing and able to abstain from using any new ocular lubricants
排除标准
- •diagnosis of thyroid dysfunction or rheumatoid arthritis
- •history of laser-assisted in situ keratomileusis (LASIK); any other ocular surgery within the previous 12 months
- •abnormal lid anatomy or active lid lesions
- •use of topical glaucoma medications, medications affecting the central nervous system, or hormonal drugs within the previous month
- •active ocular infection
- •pterygium
- •planned use of contact lenses, topical antibiotics, steroids, or immunomodulating drops
- •CDVA worse than 0.2 logMAR
结局指标
主要结局
Change in MGS score for the worse eye
时间窗: baseline to Week 8
Change in MGS score for the worse eye
次要结局
- Change in MGS score for the worse eye(baseline to Week 2)
- Incidence of adverse events(8 weeks)
- Change in OSDI score(Baseline to Week 8)
研究者
Melissa Bollinger, OD, FAAO
Principle Investigator
Jacksoneye