Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- scale of Schirmer I test
研究概览
简要总结
The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on ocular surface and tear inflammatory mediators in patients after Phaco+IOL.
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)
入排标准
- 年龄范围
- 60 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60-72 years old
- •classification of lens nucleus is LOCS Ⅱ
排除标准
- •patients with previous history of ocular surgery, corneal diseases,uveitis ,ocular hypertension or glaucoma ,systemic diseases.
研究组 & 干预措施
Hylo-Comod
The patients used Hylo-Comod eye drop after phaco+IOL in this group.
干预措施: Hylo-Comod eye drop (Drug)
Tears Naturale Forte
The patients used Tears Naturale Forte eye drop after phaco+IOL in this group.
干预措施: Tears Naturale Forte eye drop (Drug)
结局指标
主要结局
scale of Schirmer I test
时间窗: up to 2 months after surgery
scale of corneal fluorescein staining
时间窗: up to 2 months after surgery
scale of noninvasive tear breakup time
时间窗: up to 2 months after surgery
questionnaire of ocular surface disease index
时间窗: up to 2 months after surgery
scale of central corneal sensitivity
时间窗: up to 2 months after surgery
scale of tear meniscus height
时间窗: up to 2 months after surgery
concentration of Interleukin-1α
时间窗: up to 2 months after surgery
concentration of tumor necrosis factor-α
时间窗: up to 2 months after surgery
concentration of nerve growth factor
时间窗: up to 2 months after surgery
concentration of interferon-γ
时间窗: up to 2 months after surgery
concentration of transforming growth factor-β1
时间窗: up to 2 months after surgery
concentration of matrix metalloproteinase-9
时间窗: up to 2 months after surgery
次要结局
- Correlation Between Inflammatory Mediators and Ocular Surface Changes(up to 2 months after surgery)
研究者
Xingwu Zhong, MD PhD
Professor
Sun Yat-sen University