Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01544192
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2011-10-19
Brief Title:
Impact of Oral Versatile Antioxidants on Glaucoma Progression
Sponsor:
Bagcilar Training and Research Hospital
Organization:
Bagcilar Training and Research Hospital
Study Overview
Official Title:
Impact of Oral Versatile Antioxidants on Glaucoma ProgressionComparative Early Results
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cd ratios were recorded The data were compared statistically
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 cd 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 p005 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 p005 p001 In the comparison of Vitamin E with GB MD values were found significantly higher and PSD values were significantly low p005 No statistically significant difference was present between I-RNFL levels of groups p005 While the difference between cd levels of groups were highly significant p001 Table 3 cd levels of Vit E and GB groups were found significantly lower than cd levels of AOF and Control groups p001 cd level of the Vit E group is significantly lower than cd levels of AOF and Control groups p001 No statistically significant difference was found between cd levels of other groups p005
No statistically significant difference was present between s-GCC and i-GCC levels of groups p005 A high statistically significant difference was found between m-GCC levels of groups p001 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 p001 p005 m-GCC level of the Group GB was significantly higher than that of Group AOF p005 No statistically significant difference was observed between m-GCC levels of other groups p005
No statistically significant difference was present between s-GCC and i-GCC levels of groups p005 A high statistically significant difference was found between m-GCC levels of groups p001 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 p001 p005 m-GCC level of the Group GB was significantly higher than that of Group AOF p005 No statistically significant difference was observed between m-GCC levels of other groups p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None