Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Subjects discontinuing Topical Immunomodulator use
研究概览
简要总结
Purpose: To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication.
详细描述
Prospective, non-randomized, interventional study. Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate. All subjects underwent a vectored thermal pulsation treatment (LipiFlow). Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment. Data collected included tear osmolarity, tear break up time (TBUT), tear meniscus height (TMH), meibomian gland function and patient-reported symptoms using the ocular surface disease index (OSDI) questionnaire. Following the 3-month visit, patients were given the option to resume topical immunomodulator therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No prior history of meibomian gland treatment procedures LipiFlow, TearCare, or I-Lux
- •lifitegrast or cyclosporine eye drops daily for a period of at least one year but not exceeding five years
- •Meibograpy documneted retention of at least 50% of meibomian glands.
排除标准
- •evidence of meibomian gland dropout exceeding 50%
- •ocular rosacea,
- •ocular surgery within the preceding three months
- •prior in-office thermal meibomian gland treatment
- •ocular trauma within preceding three months
- •ocular herpetic infection
- •chronic or recurrent inflammation
- •eyelid abnormalities affecting lid function ocular surface abnormalities compromising corneal integrity (eg, epithelial basement membrane dystrophy, corneal burn)
结局指标
主要结局
Number of Subjects discontinuing Topical Immunomodulator use
时间窗: 3 months
OSDI, TBUT, Tear Osmolarity, Meibomian gland expression quantity, TM
次要结局
未报告次要终点
研究者
Steve Ferguson
Lead Optometrist/ Director of Dry Eye Treatment Center
Dunes Eye Consultants