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Impact of Oral Versatile Antioxidants on Glaucoma Progression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01544192
First received: October 19, 2011
Last updated: March 2, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Retinal nerve fiber layer thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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
Other Name: Placebo
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
Other Name: Placebo
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
Other Name: Placebo
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
Other Name: Placebo
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
Other Name: Placebo
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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Health Authority: Turkey: Ministry of Health

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
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013