drugset / Trial / NCT01544192

Impact of Oral Versatile Antioxidants on Glaucoma Progression

NCT01544192

Phase 3 Completed 60 enrolled Bagcilar Training and Research Hospital
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2008-04
Primary completion
2009-11
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Antioxidant formula Unknown 1 unknown Oral
Comparator Gingko Biloba Unknown 60 mg Oral
Comparator α-Tocopherol Unknown 300 mg Oral

Indications