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Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.
Hypothesis: Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main (Mexidol and standard therapy) | Active Comparator | Mexidol IM 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; IOP normalizing therapy |
|
| Control (standard therapy) | No Intervention | IOP normalizing therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mexidol | Drug | Neurocytoprotector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of expression of mitochondrial dysfunction | Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase) | 90 days |
| Dynamics of the structural and functional characteristics of mitochondria | Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Аssessment of differential light sensitivity of the retina | Dynamics of index of mean deviation (MD) of retinal photosensitivity [Static Automated Perimetry (SAP)] | 90 days |
| Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tyumen Scientific Center of the Russian Academy of Sciences | Tyumen | Russian Federation | 625026 | Russia |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C070020 | emoxypine succinate |
| C517040 | ethylmethylhydroxypyridine succinate |
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The average thickness of retinal nerve fibers (RNFL) of the peripapillary zone in four quadrants was studied using the Fast RNFL Thickness program and the thickness of the retinal ganglion cell complex (GCC-Ganglion Cell Complex protocol) |
| 90 days |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Adverse events related to Mexidol | 90 days |