A Randomized Controlled Trial Of The Effect Of Tropical Fruits On Intraocular Pressure And Retinal Nerve Fibre Layer Thickness In Patients With Primary Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- intraocular pressure
研究概览
简要总结
To evaluate the effect of regular tropical fruits intake in primary glaucoma patients.
Methodology :
Research Design Randomized controlled trial
Study Duration February 2024-June 2025
Study Location
- Ophthalmology Clinic, Hospital Universiti Sains Malaysia, Kelantan
Source Reference Population Adults with primary glaucoma in Peninsular Malaysia
Study Source Population Adults with primary glaucoma attending Ophthalmology clinic, Hospital Universiti Sains Malaysia during study duration.
详细描述
General objective To evaluate the effect of regular tropical fruits intake on intra-ocular pressure (IOP) and retinal nerve fibre layer thickness (RNFL) in primary glaucoma patients.
Research hypothesis
- There is a significant different in the IOP measurement between those whose taking regular tropical fruits and not taking them at baseline, 1 month, 3 month and 6 month among patients with primary glaucoma.
- There is a significant different in RNFL thickness between those whose taking regular tropical fruits and not taking them at baseline, 1 month, 3 month and 6 month among patients with primary glaucoma.
Inclusion Criteria
- Patient with confirmed diagnosis of POAG and PACG
- Patient on medical treatment and achieved target IOP in last 6 months
- Good compliance with pressure lowering agents
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with confirmed diagnosis of POAG and PACG
- •Patient on medical treatment and achieved target IOP in last 6 months
- •Good compliance with pressure lowering agents
排除标准
- •Poorly controlled diabetes mellitus, hypertension and hyperlipidaemia
- •Active smoker
- •Mentally challenge based on diagnosis
- •History of previous intraocular surgery other than uncomplicated cataract surgery within past 6 months
- •Poor signal strength OCT RNFL
- •Patient with media opacities that affect the reliability of OCT measurements , such as Cornea opacity, dense cataract with LOCS III of more than grade 2, vitreous haemorrhage
- •Other optic neuropathy apart from glaucoma
- •History of taking antioxidant supplement 3 months prior to recruitment
结局指标
主要结局
intraocular pressure
时间窗: baseline, at 1 month , at 3 months and 6 months
tonometer
retinal nerve fibre layer
时间窗: baseline, at 1 month , at 3 months and 6 months
Spectral domain Cirrus HD-OCT
次要结局
未报告次要终点
研究者
NURUL MUNIRAH BINTI MOHAMAD
Principle Investigator
Universiti Sains Malaysia