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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Gingko Biloba; Drug: α-tocopherol; Drug: Placebo; Drug: Antioxidant formula

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Bakırkoy Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who received follow-up in our glaucoma polyclinics

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: retinal nerve fiber thickness	Drug: Gingko Biloba; 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey); Other Names: Gingko Biloba (Vega Natural, Konya, Turkey); Drug: α-tocopherol; 2x300 mg α-tocopherol; Other Names: α-tocopherol (Roche Pharma, Istanbul, Turkey); Drug: Placebo; control group did not receive oral neuroprotective agent; Drug: Antioxidant formula; 2x1 tablet AOF; Other Names: AOF (Vega Natural, Konya, Turkey)
Active Comparator: Mean Deviation	Drug: Gingko Biloba; 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey); Other Names: Gingko Biloba (Vega Natural, Konya, Turkey); Drug: α-tocopherol; 2x300 mg α-tocopherol; Other Names: α-tocopherol (Roche Pharma, Istanbul, Turkey); Drug: Placebo; control group did not receive oral neuroprotective agent; Drug: Antioxidant formula; 2x1 tablet AOF; Other Names: AOF (Vega Natural, Konya, Turkey)
Active Comparator: Pattern Standard Deviation	Drug: Gingko Biloba; 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey); Other Names: Gingko Biloba (Vega Natural, Konya, Turkey); Drug: α-tocopherol; 2x300 mg α-tocopherol; Other Names: α-tocopherol (Roche Pharma, Istanbul, Turkey); Drug: Placebo; control group did not receive oral neuroprotective agent; Drug: Antioxidant formula; 2x1 tablet AOF; Other Names: AOF (Vega Natural, Konya, Turkey)
Active Comparator: ganglion cell count	Drug: Gingko Biloba; 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey); Other Names: Gingko Biloba (Vega Natural, Konya, Turkey); Drug: α-tocopherol; 2x300 mg α-tocopherol; Other Names: α-tocopherol (Roche Pharma, Istanbul, Turkey); Drug: Placebo; control group did not receive oral neuroprotective agent; Drug: Antioxidant formula; 2x1 tablet AOF; Other Names: AOF (Vega Natural, Konya, Turkey)
Active Comparator: c/d ratios	Drug: Gingko Biloba; 2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey); Other Names: Gingko Biloba (Vega Natural, Konya, Turkey); Drug: α-tocopherol; 2x300 mg α-tocopherol; Other Names: α-tocopherol (Roche Pharma, Istanbul, Turkey); Drug: Placebo; control group did not receive oral neuroprotective agent; Drug: Antioxidant formula; 2x1 tablet AOF; Other Names: AOF (Vega Natural, Konya, Turkey)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retinal nerve fiber layer thickness	3 months

Collaborators and Investigators

• Sponsor: Bagcilar Training and Research Hospital
• Investigators: Study Director: Kaya N Engin, MD,PhD, Bagcilar TRH

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): March 5, 2012
• Last Update Submitted That Met QC Criteria: March 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Retina; Vitamin E; Glaucoma; Neuroprotection; Antioxidant; α-tocopherol; Gingko Biloba
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Vitamin E; Tocopherols; alpha-Tocopherol; Antioxidants; Tocotrienols
• Other Study ID Numbers: BEAH-Ophthalmol-1