Evaluation of Eye Health Benefits of Black Tomato Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Grading of Retinal Vascular Diameter
研究概览
简要总结
Verification of the efficacy of black tomato extract for eye health.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age greater than 20 and capable of providing informed consent.
- •Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).
- •BMI between 22 and
- •High myopia population (-5.00 to -9.00D)
排除标准
- •History of any eye surgery (e.g., strabismus surgery, refractive surgery).
- •Presence of systemic diseases affecting the anterior surface of the eye.
- •Long-term use of medications affecting the anterior surface of the eye.
结局指标
主要结局
Grading of Retinal Vascular Diameter
时间窗: Change from Baseline at 8 weeks
Measurement of Grading of Retinal Vascular Diameter using a fundus camera.
Positive Relative Accommodation (PRA)
时间窗: Change from Baseline at 8 weeks
Measurement of Positive Relative Accommodation using a phoropter.
Accommodative Facility
时间窗: Change from Baseline at 8 weeks
Measurement of Accommodative Facility using a Flipper lens ±2.00D.
Positive Fusional Vergence (PFV)
时间窗: Change from Baseline at 8 weeks
Measurement of Positive Fusional Vergence using a phoropter.
Intraocular Pressure Measurement (IOP)
时间窗: Change from Baseline at 8 weeks
Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg
Visual Contrast Sensitivity Function
时间窗: Change from Baseline at 8 weeks
Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions.
Negative Fusional Vergence (NFV)
时间窗: Change from Baseline at 8 weeks
Measurement of Negative Fusional Vergence using a phoropter.
Negative Relative Accommodation (NRA)
时间窗: Change from Baseline at 8 weeks
Measurement of Negative Relative Accommodation using a phoropter.
次要结局
- Best-corrected visual acuity(Change from Baseline at 8 weeks)
- The change of Endothelin-1 (ET-1)(Change from Baseline at 8 weeks)
- The change of Tumor necrosis factor-α (TNF-α)(Change from Baseline at 8 weeks)
- Questionnaire Survey - Ocular Surface Disease Index (OSDI)(Change from Baseline at 8 weeks)