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Impact of Oral Versatile Antioxidants on Glaucoma Progression

NCT01544192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-03-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gingko Biloba

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

DRUG

α-tocopherol

2x300 mg α-tocopherol

DRUG

Placebo

control group did not receive oral neuroprotective agent

DRUG

Antioxidant formula

2x1 tablet AOF

Sponsors & Collaborators

  • Bagcilar Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Kaya N Engin, MD,PhD · Bagcilar TRH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-11-30
Completion
2012-02-29

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544192 on ClinicalTrials.gov