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Impact of Oral Versatile Antioxidants on Glaucoma Progression

Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01544192
Enrollment
60
Registered
2012-03-05
Start date
2008-04-30
Completion date
2012-02-29
Last updated
2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Antioxidant, α-tocopherol, Vitamin E, Gingko Biloba, Glaucoma, Neuroprotection, Retina

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).

Interventions

2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)

2x300 mg α-tocopherol

DRUGPlacebo

control group did not receive oral neuroprotective agent

2x1 tablet AOF

Sponsors

Bagcilar Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

Inclusion criteria

* Patients who received follow-up in our glaucoma polyclinics

Exclusion criteria

* Known ocular or systemic concomitant disorders * Previous glaucoma surgeries * Antioxidant usage

Design outcomes

Primary

MeasureTime frame
Retinal nerve fiber layer thickness3 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026