Impact of Oral Versatile Antioxidants on Glaucoma Progression

NCT ID: NCT01544192

Last Updated: 2012-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

retinal nerve fiber thickness

Group Type ACTIVE_COMPARATOR

Gingko Biloba

Intervention Type DRUG

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

α-tocopherol

Intervention Type DRUG

2x300 mg α-tocopherol

Placebo

Intervention Type DRUG

control group did not receive oral neuroprotective agent

Antioxidant formula

Intervention Type DRUG

2x1 tablet AOF

Mean Deviation

Group Type ACTIVE_COMPARATOR

Gingko Biloba

Intervention Type DRUG

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

α-tocopherol

Intervention Type DRUG

2x300 mg α-tocopherol

Placebo

Intervention Type DRUG

control group did not receive oral neuroprotective agent

Antioxidant formula

Intervention Type DRUG

2x1 tablet AOF

Pattern Standard Deviation

Group Type ACTIVE_COMPARATOR

Gingko Biloba

Intervention Type DRUG

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

α-tocopherol

Intervention Type DRUG

2x300 mg α-tocopherol

Placebo

Intervention Type DRUG

control group did not receive oral neuroprotective agent

Antioxidant formula

Intervention Type DRUG

2x1 tablet AOF

ganglion cell count

Group Type ACTIVE_COMPARATOR

Gingko Biloba

Intervention Type DRUG

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

α-tocopherol

Intervention Type DRUG

2x300 mg α-tocopherol

Placebo

Intervention Type DRUG

control group did not receive oral neuroprotective agent

Antioxidant formula

Intervention Type DRUG

2x1 tablet AOF

c/d ratios

Group Type ACTIVE_COMPARATOR

Gingko Biloba

Intervention Type DRUG

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

α-tocopherol

Intervention Type DRUG

2x300 mg α-tocopherol

Placebo

Intervention Type DRUG

control group did not receive oral neuroprotective agent

Antioxidant formula

Intervention Type DRUG

2x1 tablet AOF

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gingko Biloba

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

Intervention Type DRUG

α-tocopherol

2x300 mg α-tocopherol

Intervention Type DRUG

Placebo

control group did not receive oral neuroprotective agent

Intervention Type DRUG

Antioxidant formula

2x1 tablet AOF

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Gingko Biloba (Vega Natural, Konya, Turkey) α-tocopherol (Roche Pharma, Istanbul, Turkey) AOF (Vega Natural, Konya, Turkey)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who received follow-up in our glaucoma polyclinics

Exclusion Criteria

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

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kaya N Engin, MD,PhD

Role: STUDY_DIRECTOR

Bagcilar TRH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bakırköy Şadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BEAH-Ophthalmol-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nicotinamide and Glaucoma
NCT05916066 COMPLETED NA
The Canadian Glaucoma Study
NCT00262626 TERMINATED NA