Impact of Oral Versatile Antioxidants on Glaucoma Progression

Bagcilar Training and Research Hospital

Status and phase: Completed; Phase 3

Conditions: Glaucoma

Treatments: Drug: α-tocopherol; Drug: Antioxidant formula; Drug: Placebo; Drug: Gingko Biloba

Study type: Interventional

Funder types: Other

Identifiers

NCT01544192

BEAH-Ophthalmol-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received follow-up in our glaucoma polyclinics

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 5 patient groups

retinal nerve fiber thickness

Active Comparator group

Treatment:

Drug: Gingko Biloba

Drug: Antioxidant formula

Drug: α-tocopherol

Drug: Placebo

Mean Deviation

Active Comparator group

Treatment:

Drug: Gingko Biloba

Drug: Antioxidant formula

Drug: α-tocopherol

Drug: Placebo

Pattern Standard Deviation

Active Comparator group

Treatment:

Drug: Gingko Biloba

Drug: Antioxidant formula

Drug: α-tocopherol

Drug: Placebo

ganglion cell count

Active Comparator group

Treatment:

Drug: Gingko Biloba

Drug: Antioxidant formula

Drug: α-tocopherol

Drug: Placebo

c/d ratios

Active Comparator group

Treatment:

Drug: Gingko Biloba

Drug: Antioxidant formula

Drug: α-tocopherol

Drug: Placebo