Impact of Oral Versatile Antioxidants on Glaucoma Progression
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Gingko Biloba; α-tocopherol; Placebo; Antioxidant formula
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey); 2x300 mg α-tocopherol; control group did not receive oral neuroprotective agent; 2x1 tablet AOF
Other intervention name(s): Gingko Biloba (Vega Natural, Konya, Turkey); α-tocopherol (Roche Pharma, Istanbul, Turkey); AOF (Vega Natural, Konya, Turkey)
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Antioxidant; α-tocopherol; Vitamin E; Gingko Biloba; Glaucoma; Neuroprotection; Retina