Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Tear film osmolarity change
研究概览
简要总结
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.
详细描述
Prospective study design among subjects with MGD and qualifying for IPL therapy.
Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.
No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •No history of ocular infection or corneal degeneration/dystrophy
- •No history of corneal refractive surgery
- •No change in ocular medications in the last 2 months
结局指标
主要结局
Tear film osmolarity change
时间窗: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
次要结局
未报告次要终点