Trial | NCT01544192  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin e yinhsing ...

  • Study Participants

    60
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.
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).
Study Started
Apr 30
2008
Primary Completion
Nov 30
2009
Study Completion
Feb 29
2012
Last Update
Mar 05
2012
Estimate

Drug Gingko Biloba

2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)

  • Other names: Gingko Biloba (Vega Natural, Konya, Turkey)

Drug α-tocopherol

2x300 mg α-tocopherol

  • Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey)

Drug Placebo

control group did not receive oral neuroprotective agent

Drug Antioxidant formula

2x1 tablet AOF

  • Other names: AOF (Vega Natural, Konya, Turkey)

retinal nerve fiber thickness Active Comparator

Mean Deviation Active Comparator

Pattern Standard Deviation Active Comparator

ganglion cell count Active Comparator

c/d ratios Active Comparator

Criteria 

Inclusion Criteria:

Patients who received follow-up in our glaucoma polyclinics

Exclusion Criteria:

Known ocular or systemic concomitant disorders
Previous glaucoma surgeries
Antioxidant usage
No Results Posted