The Effects of Vitamin C Supplementation on Corneal Endothelial Damage in Hard Cataract Phacoemulsification: an Oxidative Stress Study on Aqueous Humour and Corneal Endothelial Cell Characteristics.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Endothelial cell loss
研究概览
简要总结
The goal of this clinical trial is to analyze the protective effects of oral ascorbic acid on the corneal endothelial layer undergoing oxidative stress due to phacoemulsification in patients with hard cataracts. The main questions it aims to answer are:
- Will oral vitamin C administration provide better protection to the corneal endothelium in hard cataract phacoemulsification by comparing preoperative and postoperative administration, preoperative only, and no administration?
- How does oxidative stress (MDA levels) in the aqueous humour increase after oral vitamin C administration compared to no administration?
- Will there any changes in MDA levels in the aqueous humour and blood after oral vitamin C administration compared to no administration?
- Does MDA levels in the aqueous humour correlate with MDA levels in the blood?
Researchers will compare vitamin C to a placebo to see if vitamin C as an antioxidant works in preventing corneal endothelial damage due to phacoemulsification.
Participants will:
- Take 500 mg of oral vitamin C or placebo three times a day for seven days prior to phacoemulsification
- Undergo phacoemulsification
- Take vitamin C or placebo three times a day for 28 days after phacoemulsification
- Visit the ophthalmology clinic 1, 7, 28, and 42 days post-operative for checkups
- Keep a logbook to record the drug they take and to write symptoms of possible side effect of the drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 60 years or older
- •Patients with immature senile cataracts in one or both eyes, with LOC (lens opacities classification) III nuclear opacity grade 4-6 and nuclear color grade 4-6 criteria
- •Patients willing to undergo phacoemulsification cataract surgery and consume the study medication as allocated, as well as participate in follow-up assessments for 7 weeks
- •Patients with no history of previous intraocular surgery
- •Patients with no history of allergy to vitamin C
- •Patients not routinely consuming other vitamins
- •Patients who agree to and sign the informed consent for the study
排除标准
- 未提供
研究组 & 干预措施
Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
干预措施: Oral Vitamin C (Drug)
Preoperative Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
干预措施: Oral Vitamin C (Drug)
Preoperative Vit C
Patient will consume 500 mg of oral vitamin C, tid, 7 days prior to phacoemulsification and placebo, tid, 4 weeks after phacoemulsification
干预措施: Placebo (Drug)
Placebo
Patient will consume placebo, tid, 7 days prior to phacoemulsification to 4 weeks after phacoemulsification
干预措施: Placebo (Drug)
结局指标
主要结局
Endothelial cell loss
时间窗: From the start of the study to six weeks after intervention
Difference of endothelial cell density before and after phacoemulsification
次要结局
- Serum ascorbic acid levels(From the start of the study to seven days after intervention)
- Serum total antioxidant capacity levels(From the start of the study to seven days after intervention)
- Serum malondialdehyde levels(From the start of the study to seven days after intervention)
- Aqueous ascorbic acid levels(Right before phacoemulsification)
- Aqueous total antioxidant capacity levels(Right before phacoemulsification)
- Aqueous malondialdehyde levels(Right before phacoemulsification to 3 minutes after phacoemulsification)
- Central corneal thickness(rom the start of the study to six weeks after intervention)
- Grading of cells in anterior chamber(From the start of the study to six weeks after intervention)
- Visual acuity of patients(From the start of the study to six weeks after intervention)
研究者
Melva Louisa
Prof. dr. Melva Louisa, S.Si., M.Biomed
Indonesia University