Impact of Oral Versatile Antioxidants on Glaucoma Progression

Sponsor

Bagcilar Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01544192

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Gingko Biloba Drug: α-tocopherol Drug: Placebo Drug: Antioxidant formula	Phase 3

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: retinal nerve fiber thickness	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)
Active Comparator: Mean Deviation	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)
Active Comparator: Pattern Standard Deviation	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)
Active Comparator: ganglion cell count	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)
Active Comparator: c/d ratios	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)