Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Average LLT (LLTave)
研究概览
简要总结
Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT.
Objective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry.
Design, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE.
Interventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).
Main Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.
- •tear meniscus height (TMH) of <200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
- •evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.
排除标准
- •acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.
- •a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.
- •any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
- •Hypersecretory meibomian gland dysfunction (MGD)
- •When both eyes of a patient could be included, an eye with the lower TMH was selected.
研究组 & 干预措施
Group 2
3% diquafosol eye drops 6 times / day
干预措施: 3% diquafosol eyedrops (Drug)
Group 3
Punctal plug insertion, lower eyelid
干预措施: Silicone punctal plug insertion (Procedure)
Group 4
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
干预措施: 3% diquafosol eyedrops (Drug)
Group 4
3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid
干预措施: Silicone punctal plug insertion (Procedure)
结局指标
主要结局
Average LLT (LLTave)
时间窗: Baseline and one month after 1 month of treatments
LLT was measured using the LipiView® II tear interferometer (Johnson \& Johnson, New Brunswick, New Jersey, USA). The tear interferometer automatically records 20-second videos reflecting the TFLL on the inferior cornea. Simultaneously, the quantified LLT is measured over time in the interferometric color unit (ICU). One ICU corresponds to approximately 1 nm of LLT. The LipiView® II interferometer provides the average, maximum, and minimum LLT values. The average LLT (LLTave) reflects the LLT value at the stable phase of the TFLL spreading or equilibrium state.
次要结局
未报告次要终点