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Completed

NCT Number: NCT01544192

Impact of Oral Versatile Antioxidants on Glaucoma Progression

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bakırköy Şadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received follow-up in our glaucoma polyclinics

Exclusion criteria

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

Treatment and study plan

Gingko Biloba

Drug

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

Other names: Gingko Biloba (Vega Natural, Konya, Turkey)

α-tocopherol

Drug

2x300 mg α-tocopherol

Other names: α-tocopherol (Roche Pharma, Istanbul, Turkey)

Placebo

Drug

control group did not receive oral neuroprotective agent

Antioxidant formula

Drug

2x1 tablet AOF

Other names: AOF (Vega Natural, Konya, Turkey)

Primary outcomes

  1. Retinal nerve fiber layer thickness

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Mar 5, 2012
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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