Impact of Oral Versatile Antioxidants on Glaucoma Progression
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| ClinicalTrials.gov Identifier: NCT01544192 |
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Recruitment Status
:
Completed
First Posted
: March 5, 2012
Last Update Posted
: March 5, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glaucoma | Drug: Gingko Biloba Drug: α−tocopherol Drug: Placebo Drug: Antioxidant formula | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| 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 : | April 2008 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | February 2012 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: retinal nerve fiber thickness |
Drug: Gingko Biloba
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Other Name: Gingko Biloba (Vega Natural, Konya, Turkey)
Drug: α−tocopherol
2x300 mg α−tocopherol
Other Name: α−tocopherol (Roche Pharma, Istanbul, Turkey)
Drug: Placebo
control group did not receive oral neuroprotective agent
Drug: Antioxidant formula
2x1 tablet AOF
Other Name: AOF (Vega Natural, Konya, Turkey)
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| Active Comparator: Mean Deviation |
Drug: Gingko Biloba
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Other Name: Gingko Biloba (Vega Natural, Konya, Turkey)
Drug: α−tocopherol
2x300 mg α−tocopherol
Other Name: α−tocopherol (Roche Pharma, Istanbul, Turkey)
Drug: Placebo
control group did not receive oral neuroprotective agent
Drug: Antioxidant formula
2x1 tablet AOF
Other Name: AOF (Vega Natural, Konya, Turkey)
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| Active Comparator: Pattern Standard Deviation |
Drug: Gingko Biloba
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Other Name: Gingko Biloba (Vega Natural, Konya, Turkey)
Drug: α−tocopherol
2x300 mg α−tocopherol
Other Name: α−tocopherol (Roche Pharma, Istanbul, Turkey)
Drug: Placebo
control group did not receive oral neuroprotective agent
Drug: Antioxidant formula
2x1 tablet AOF
Other Name: AOF (Vega Natural, Konya, Turkey)
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| Active Comparator: ganglion cell count |
Drug: Gingko Biloba
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Other Name: Gingko Biloba (Vega Natural, Konya, Turkey)
Drug: α−tocopherol
2x300 mg α−tocopherol
Other Name: α−tocopherol (Roche Pharma, Istanbul, Turkey)
Drug: Placebo
control group did not receive oral neuroprotective agent
Drug: Antioxidant formula
2x1 tablet AOF
Other Name: AOF (Vega Natural, Konya, Turkey)
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| Active Comparator: c/d ratios |
Drug: Gingko Biloba
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Other Name: Gingko Biloba (Vega Natural, Konya, Turkey)
Drug: α−tocopherol
2x300 mg α−tocopherol
Other Name: α−tocopherol (Roche Pharma, Istanbul, Turkey)
Drug: Placebo
control group did not receive oral neuroprotective agent
Drug: Antioxidant formula
2x1 tablet AOF
Other Name: AOF (Vega Natural, Konya, Turkey)
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- Retinal nerve fiber layer thickness [ Time Frame: 3 months ]
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| Ages Eligible for Study: | 18 Years to 67 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who received follow-up in our glaucoma polyclinics
Exclusion Criteria:
- Known ocular or systemic concomitant disorders
- Previous glaucoma surgeries
- Antioxidant usage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544192
| Turkey | |
| Bakırköy Şadi Konuk Training and Research Hospital | |
| Istanbul, Turkey, 34147 | |
| Study Director: | Kaya N Engin, MD,PhD | Bagcilar TRH |
| Responsible Party: | Bagcilar Training and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01544192 History of Changes |
| Other Study ID Numbers: |
BEAH-Ophthalmol-1 |
| First Posted: | March 5, 2012 Key Record Dates |
| Last Update Posted: | March 5, 2012 |
| Last Verified: | February 2012 |
Keywords provided by Bagcilar Training and Research Hospital:
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Antioxidant α−tocopherol Vitamin E Gingko Biloba |
Glaucoma Neuroprotection Retina |
Additional relevant MeSH terms:
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Glaucoma Ocular Hypertension Eye Diseases Antioxidants Tocopherols Vitamin E Tocotrienols |
alpha-Tocopherol Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |