Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Retinal nerve fiber layer thickness
研究概览
简要总结
Background: The significance of retinal ganglion cell protection in the glaucoma led the view that, glaucomatous optical neuropathy can also be considered as a pathology of central nervous system. It is known that α-tocopherol and Gingko Biloba have specific neuroprotective and vasoregulatory activities, in addition to antioxidant effects. In this study, the investigators compared early neuroprotective effects of α-tocopherol and GB with each other as well as control and a strong antioxidant formulation in patients with glaucoma.
Methods: In this non-randomized control trial, 120 eyes of 60 patients with glaucoma were enrolled into the study and divided into 4 groups, each consisting of 30 eyes. Unlike the controls, patients in the 3 antioxidant groups received α-tocopherol, Gingko Biloba and a strong antioxidant formula for 3 months. Central vision field and MD, PSD and OCT as well as thickness of retinal nerve fiber layer, ganglion cell counts and c/d ratios were recorded. The data were compared statistically.
详细描述
A significant difference was observed between MD, PSD, s-RNFL and m-RNFL levels of groups (p<0.05) (Table 3), but when compared with Groups of Vit E and AOF, MD and s-RNFL levels of the Group GB were significantly low and PSD level was significantly high in the same group. m-RNFL level of the Vit E group was significantly higher than m-RNFL levels of GB, AOF and Control groups (p<0.05, p<0.01). In the comparison of Vitamin E with GB, MD values were found significantly higher and PSD values were significantly low (p<0.05). No statistically significant difference was present between I-RNFL levels of groups (p>0.05). While the difference between c/d levels of groups were highly significant (p<0.01) (Table 3), c/d levels of Vit E and GB groups were found significantly lower than c/d levels of AOF and Control groups (p<0.01). c/d level of the Vit E group is significantly lower than c/d levels of AOF and Control groups (p<0.01). No statistically significant difference was found between c/d levels of other groups (p>0.05).
No statistically significant difference was present between s-GCC and i-GCC levels of groups (p>0.05). A high statistically significant difference was found between m-GCC levels of groups (p<0.01). While highly 201 significant and significant difference were present between m-GCC level of the Vit E Group and m-GCC levels of AOF and Control Groups, respectively, (p<0.01, p<0.05), m-GCC level of the Group GB was significantly higher than that of Group AOF (p<0.05). No statistically significant difference was observed between m-GCC levels of other groups (p>0.05).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 67 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received follow-up in our glaucoma polyclinics
排除标准
- •Known ocular or systemic concomitant disorders
- •Previous glaucoma surgeries
- •Antioxidant usage
研究组 & 干预措施
retinal nerve fiber thickness
干预措施: Gingko Biloba (Drug)
retinal nerve fiber thickness
干预措施: α-tocopherol (Drug)
retinal nerve fiber thickness
干预措施: Placebo (Drug)
retinal nerve fiber thickness
干预措施: Antioxidant formula (Drug)
Mean Deviation
干预措施: Gingko Biloba (Drug)
Mean Deviation
干预措施: α-tocopherol (Drug)
Mean Deviation
干预措施: Placebo (Drug)
Mean Deviation
干预措施: Antioxidant formula (Drug)
Pattern Standard Deviation
干预措施: Gingko Biloba (Drug)
Pattern Standard Deviation
干预措施: α-tocopherol (Drug)
Pattern Standard Deviation
干预措施: Placebo (Drug)
Pattern Standard Deviation
干预措施: Antioxidant formula (Drug)
ganglion cell count
干预措施: Gingko Biloba (Drug)
ganglion cell count
干预措施: α-tocopherol (Drug)
ganglion cell count
干预措施: Placebo (Drug)
ganglion cell count
干预措施: Antioxidant formula (Drug)
c/d ratios
干预措施: Gingko Biloba (Drug)
c/d ratios
干预措施: α-tocopherol (Drug)
c/d ratios
干预措施: Placebo (Drug)
c/d ratios
干预措施: Antioxidant formula (Drug)
结局指标
主要结局
Retinal nerve fiber layer thickness
时间窗: 3 months
次要结局
未报告次要终点
