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Impact of Oral Versatile Antioxidants on Glaucoma Progression

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ClinicalTrials.gov Identifier: NCT01544192
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital

Study Description
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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
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Tocopherol

Arms and Interventions
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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)
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)


Outcome Measures
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Primary Outcome Measures :
  1. Retinal nerve fiber layer thickness [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Turkey
Bakırköy Şadi Konuk Training and Research Hospital
Istanbul, Turkey, 34147
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
Study Director: Kaya N Engin, MD,PhD Bagcilar TRH
More Information
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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:
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