Impact of Oral Versatile Antioxidants on Glaucoma Progression

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Gingko Biloba
* Drug: α-tocopherol
* Drug: Placebo
* Drug: Antioxidant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received follow-up in our glaucoma polyclinics Exclusion Criteria: Known ocular or systemic concomitant disorders Previous glaucoma surgeries Antioxidant usage

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: retinal nerve fiber thickness<br> | Drug: Gingko Biloba<br>* 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)<br>* Other names: Gingko Biloba (Vega Natural, Konya, Turkey);Drug: α-tocopherol<br>* 2x300 mg α-tocopherol<br>* Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey);Drug: Placebo<br>* control group did not receive oral neuroprotective agent<br>Drug: Antioxidant formula<br>* 2x1 tablet AOF<br>* Other names: AOF (Vega Natural, Konya, Turkey);|
| Active Comparator: Mean Deviation<br> | Drug: Gingko Biloba<br>* 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)<br>* Other names: Gingko Biloba (Vega Natural, Konya, Turkey);Drug: α-tocopherol<br>* 2x300 mg α-tocopherol<br>* Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey);Drug: Placebo<br>* control group did not receive oral neuroprotective agent<br>Drug: Antioxidant formula<br>* 2x1 tablet AOF<br>* Other names: AOF (Vega Natural, Konya, Turkey);|
| Active Comparator: Pattern Standard Deviation<br> | Drug: Gingko Biloba<br>* 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)<br>* Other names: Gingko Biloba (Vega Natural, Konya, Turkey);Drug: α-tocopherol<br>* 2x300 mg α-tocopherol<br>* Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey);Drug: Placebo<br>* control group did not receive oral neuroprotective agent<br>Drug: Antioxidant formula<br>* 2x1 tablet AOF<br>* Other names: AOF (Vega Natural, Konya, Turkey);|
| Active Comparator: ganglion cell count<br> | Drug: Gingko Biloba<br>* 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)<br>* Other names: Gingko Biloba (Vega Natural, Konya, Turkey);Drug: α-tocopherol<br>* 2x300 mg α-tocopherol<br>* Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey);Drug: Placebo<br>* control group did not receive oral neuroprotective agent<br>Drug: Antioxidant formula<br>* 2x1 tablet AOF<br>* Other names: AOF (Vega Natural, Konya, Turkey);|
| Active Comparator: c/d ratios<br> | Drug: Gingko Biloba<br>* 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)<br>* Other names: Gingko Biloba (Vega Natural, Konya, Turkey);Drug: α-tocopherol<br>* 2x300 mg α-tocopherol<br>* Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey);Drug: Placebo<br>* control group did not receive oral neuroprotective agent<br>Drug: Antioxidant formula<br>* 2x1 tablet AOF<br>* Other names: AOF (Vega Natural, Konya, Turkey);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal nerve fiber layer thickness |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antioxidant, α-tocopherol, Vitamin E, Gingko Biloba, Glaucoma, Neuroprotection, Retina