Clinical trial NCT01544192: Impact of Oral Versatile Antioxidants on Glaucoma Progression
Official title: Impact of Oral Versatile Antioxidants on Glaucoma Progression:Comparative Early Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Keywords: Antioxidant
α-tocopherol
Vitamin E
Gingko Biloba
Glaucoma
Neuroprotection
Retina
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* Patients who received follow-up in our glaucoma polyclinics

Exclusion Criteria:

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

Primary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Şadi Konuk Training and Research Hospital
Study officials:
affiliation: Bagcilar TRH
name: Kaya N Engin, MD,PhD
role: STUDY_DIRECTOR
References: