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临床试验/NCT06235827
NCT06235827招募中不适用

Effects of Green Tea Consumption on Retinal Nerve Fiber Layer ( RNFL) and Intraocular Pressure ( IOP) in Patients With Primary Glaucoma

Universiti Sains Malaysia2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Effect of green tea consumption on intraocular pressure in patient with primary glaucoma

研究概览

简要总结

The goal of this randomised control trial is to learn about the effect of green tea consumption on patients with primary glaucoma.

The main questions to answer are:

  1. Is there any difference of intraocular pressure (IOP) in patient with primary glaucoma after 1 month, 3 months and 6 months who is consuming green tea compared to patient not consuming green tea?
  2. Is there any difference of retina nerve fibre layer in patient with primary glaucoma after 1 month, 3months and 6 months who is consuming green tea compared to patient not consuming green tea?

Researchers will compare patients with primary glaucoma who are consuming green tea and normal daily drinking to see if any affect to intraocular pressure and retina nerve fibre layer.

详细描述

Glaucoma is a progressive optic neuropathy characterised by loss of retinal ganglion cells (RGCs) with corresponding visual field loss. The current established treatment of glaucoma is by reducing IOP, as one of neuroprotectant factor to prevent further loss RGCs. However, it is not always sufficient to fully prevent disease progression. Oxidative stress is one of biological insult contribute to etiology and progression of glaucoma. Antioxidants represent the first line of defence against oxidative stress and are obtained through the diet and produced internally has shown to be protective towards glaucoma. Green tea is one of the most antioxidant rich drink due to its high content of flavonoids commonly known as catechins.

The investigator would like to evaluate the effect of 6 months consumption of green tea on intraocular pressure (IOP) and retinal nerve fibre layer thickness (RNFL) in patients with primary glaucoma. This is a randomised controlled study involving primary glaucoma patients who are attending ophthalmology clinic at Hospital Universiti Sains Malaysia. Evaluation of study sample includes baseline ocular examination, IOP and Optical Coherence Tomography Retinal Nerve Fibre Layer (OCT RNFL). Subjects who fulfil the inclusion and exclusion criteria for the study will be selected.

Patients in Group A will consume two cups per day (250ml for each cup) of hot green tea, five days per week for 6 months while other Group B (control group) will not consume green tea. IOP and OCT RNFL measurement will be taken at baseline, first month, 3rd month and 6th month post recruitment of subjects. All patients will be given dietary diary to note down their daily drinks' consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with confirmed diagnosis of primary glaucoma (POAG/PACG/NTG) that achieve target IOP with medical therapy at least for 6 months.
  • Never consume green tea as daily drinks.

排除标准

  • Dense cataract with Lens Opacity Classification Sytem (LOCS II) of more than grade 2
  • Any other ocular media opacity that may interfere with OCT imaging ( eg: cornea scar/vitreous haemorrhage)
  • Any history of optic neuropathy
  • History of glaucoma or retinal surgery
  • Macular degeneration and retinal disorder
  • Patient with caffein sensitive that causes unpleasant reaction (eg: palpitation, insomnia, nausea, constipation)
  • Allergic to green tea

结局指标

主要结局

Effect of green tea consumption on intraocular pressure in patient with primary glaucoma

时间窗: IOP measurement will be taken at baseline, first, and 6th-month post recruitment for group A and B.

IOP measurement will be done using Goldmann Applanation Tonometer (GAT) for group A and Group B

Effect of green tea consumption on retinal nerve fiber layer thickness ( RNFL) in patient with primary glaucoma

时间窗: OCT RNFL will be conducted at baseline, 1 month, 3 month and 6 month post recruitment for group A and B.

Spectral domain Heidelberg Spectralis OCT will be used to measure RNFL thickness

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siti Sarah Binti Shokri

Dr.

Universiti Sains Malaysia

研究点 (2)

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