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临床试验/NCT01544192
NCT01544192已完成3 期

Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results

Bagcilar Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Gingko Biloba (Drug)

retinal nerve fiber thickness

Active Comparator

干预措施: α-tocopherol (Drug)

retinal nerve fiber thickness

Active Comparator

干预措施: Placebo (Drug)

retinal nerve fiber thickness

Active Comparator

干预措施: Antioxidant formula (Drug)

Mean Deviation

Active Comparator

干预措施: Gingko Biloba (Drug)

Mean Deviation

Active Comparator

干预措施: α-tocopherol (Drug)

Mean Deviation

Active Comparator

干预措施: Placebo (Drug)

Mean Deviation

Active Comparator

干预措施: Antioxidant formula (Drug)

Pattern Standard Deviation

Active Comparator

干预措施: Gingko Biloba (Drug)

Pattern Standard Deviation

Active Comparator

干预措施: α-tocopherol (Drug)

Pattern Standard Deviation

Active Comparator

干预措施: Placebo (Drug)

Pattern Standard Deviation

Active Comparator

干预措施: Antioxidant formula (Drug)

ganglion cell count

Active Comparator

干预措施: Gingko Biloba (Drug)

ganglion cell count

Active Comparator

干预措施: α-tocopherol (Drug)

ganglion cell count

Active Comparator

干预措施: Placebo (Drug)

ganglion cell count

Active Comparator

干预措施: Antioxidant formula (Drug)

c/d ratios

Active Comparator

干预措施: Gingko Biloba (Drug)

c/d ratios

Active Comparator

干预措施: α-tocopherol (Drug)

c/d ratios

Active Comparator

干预措施: Placebo (Drug)

c/d ratios

Active Comparator

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

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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