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

October 19, 2011
March 2, 2012
April 2008
November 2009   (final data collection date for primary outcome measure)
Retinal nerve fiber layer thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544192 on ClinicalTrials.gov Archive Site
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Impact of Oral Versatile Antioxidants on Glaucoma Progression
Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Glaucoma
  • 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: retinal nerve fiber thickness
    Interventions:
    • Drug: Gingko Biloba
    • Drug: α−tocopherol
    • Drug: Placebo
    • Drug: Antioxidant formula
  • Active Comparator: Mean Deviation
    Interventions:
    • Drug: Gingko Biloba
    • Drug: α−tocopherol
    • Drug: Placebo
    • Drug: Antioxidant formula
  • Active Comparator: Pattern Standard Deviation
    Interventions:
    • Drug: Gingko Biloba
    • Drug: α−tocopherol
    • Drug: Placebo
    • Drug: Antioxidant formula
  • Active Comparator: ganglion cell count
    Interventions:
    • Drug: Gingko Biloba
    • Drug: α−tocopherol
    • Drug: Placebo
    • Drug: Antioxidant formula
  • Active Comparator: c/d ratios
    Interventions:
    • Drug: Gingko Biloba
    • Drug: α−tocopherol
    • Drug: Placebo
    • Drug: Antioxidant formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2012
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who received follow-up in our glaucoma polyclinics

Exclusion Criteria:

  • Known ocular or systemic concomitant disorders
  • Previous glaucoma surgeries
  • Antioxidant usage
Both
18 Years to 67 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01544192
BEAH-Ophthalmol-1
No
Bagcilar Training and Research Hospital
Bagcilar Training and Research Hospital
Not Provided
Study Director: Kaya N Engin, MD,PhD Bagcilar TRH
Bagcilar Training and Research Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP