Impact of Oral Versatile Antioxidants on Glaucoma Progression
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Gingko Biloba
α-tocopherol
Placebo
Antioxidant formula
Sponsored by
About this trial
This is an interventional prevention trial for Glaucoma focused on measuring Antioxidant, α-tocopherol, Vitamin E, Gingko Biloba, Glaucoma, Neuroprotection, Retina
Eligibility 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
Sites / Locations
- Bakırköy Şadi Konuk Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
retinal nerve fiber thickness
Mean Deviation
Pattern Standard Deviation
ganglion cell count
c/d ratios
Arm Description
Outcomes
Primary Outcome Measures
Retinal nerve fiber layer thickness
Secondary Outcome Measures
Full Information
NCT ID
NCT01544192
First Posted
October 19, 2011
Last Updated
March 2, 2012
Sponsor
Bagcilar Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01544192
Brief Title
Impact of Oral Versatile Antioxidants on Glaucoma Progression
Official Title
Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bagcilar Training and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Antioxidant, α-tocopherol, Vitamin E, Gingko Biloba, Glaucoma, Neuroprotection, Retina
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
retinal nerve fiber thickness
Arm Type
Active Comparator
Arm Title
Mean Deviation
Arm Type
Active Comparator
Arm Title
Pattern Standard Deviation
Arm Type
Active Comparator
Arm Title
ganglion cell count
Arm Type
Active Comparator
Arm Title
c/d ratios
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Gingko Biloba
Other Intervention Name(s)
Gingko Biloba (Vega Natural, Konya, Turkey)
Intervention Description
2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
Intervention Type
Drug
Intervention Name(s)
α-tocopherol
Other Intervention Name(s)
α-tocopherol (Roche Pharma, Istanbul, Turkey)
Intervention Description
2x300 mg α-tocopherol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
control group did not receive oral neuroprotective agent
Intervention Type
Drug
Intervention Name(s)
Antioxidant formula
Other Intervention Name(s)
AOF (Vega Natural, Konya, Turkey)
Intervention Description
2x1 tablet AOF
Primary Outcome Measure Information:
Title
Retinal nerve fiber layer thickness
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaya N Engin, MD,PhD
Organizational Affiliation
Bagcilar TRH
Official's Role
Study Director
Facility Information:
Facility Name
Bakırköy Şadi Konuk Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
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Impact of Oral Versatile Antioxidants on Glaucoma Progression
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