Impact of Oral Versatile Antioxidants on Glaucoma Progression
- Conditions
- Glaucoma
- Interventions
- Registration Number
- NCT01544192
- Lead Sponsor
- Bagcilar Training and Research Hospital
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients who received follow-up in our glaucoma polyclinics
- Known ocular or systemic concomitant disorders
- Previous glaucoma surgeries
- Antioxidant usage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description retinal nerve fiber thickness Gingko Biloba - retinal nerve fiber thickness Placebo - retinal nerve fiber thickness Antioxidant formula - Mean Deviation Gingko Biloba - Mean Deviation α-tocopherol - Mean Deviation Placebo - Mean Deviation Antioxidant formula - Pattern Standard Deviation Gingko Biloba - Pattern Standard Deviation Placebo - Pattern Standard Deviation Antioxidant formula - ganglion cell count Gingko Biloba - ganglion cell count Placebo - ganglion cell count Antioxidant formula - c/d ratios Gingko Biloba - c/d ratios Placebo - c/d ratios Antioxidant formula - ganglion cell count α-tocopherol - c/d ratios α-tocopherol - retinal nerve fiber thickness α-tocopherol - Pattern Standard Deviation α-tocopherol -
- Primary Outcome Measures
Name Time Method Retinal nerve fiber layer thickness 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bakırköy Şadi Konuk Training and Research Hospital
🇹🇷Istanbul, Turkey