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Impact of Oral Versatile Antioxidants on Glaucoma Progression
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Glaucoma | Drug: Gingko Biloba Drug: α−tocopherol Drug: Placebo Drug: Antioxidant formula | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results |
- Retinal nerve fiber layer thickness [ Time Frame: 3 months ]
| Enrollment: | 60 |
| Study Start Date: | April 2008 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
| 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)
|
| 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)
|
| 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)
|
| 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)
|
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).
Eligibility| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01544192
| Turkey | |
| Bakırköy Şadi Konuk Training and Research Hospital | |
| Istanbul, Turkey, 34147 | |
| Study Director: | Kaya N Engin, MD,PhD | Bagcilar TRH |
More Information
| Responsible Party: | Bagcilar Training and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01544192 History of Changes |
| Other Study ID Numbers: |
BEAH-Ophthalmol-1 |
| Study First Received: | October 19, 2011 |
| Last Updated: | March 2, 2012 |
Keywords provided by Bagcilar Training and Research Hospital:
|
Antioxidant α−tocopherol Vitamin E Gingko Biloba |
Glaucoma Neuroprotection Retina |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on July 26, 2017