Purpose: a comparative study of the efficacy and safety of the Latanoprost-Optic drug and the original latanoprost drug administered to previously untreated patients with primary open-angle glaucoma (POAG). Material and methods. A double-blind, randomized, parallel-group study involved 60 patients (70 eyes) with newly diagnosed POAG, who were randomly divided into 2 groups of equal size. The patients of the main group (34 eyes) received Latanoprost-Optic, whilst the control group received the original preparation of latanoprost, 1 instillation in the evening. The reference points were the values of intraocular pressure, visual acuity, perimetric indices (standard deviation, standard deviation pattern), the average thickness of the retinal nerve fiber layer, the minimum width of the neuroretinal girdle, the thickness of the retinal nerve fiber layer in the macula, the thickness of the ganglion cell layer in the macula, the thickness of the inner plexiform layer, and the safety (adverse events). The observation period was 12 weeks. Results. After 2 weeks, both groups showed a statistically significant decrease in intraocular pressure, which remained stable after 6 and 12 weeks. The average decrease in intraocular pressure of those receiving Latanoprost-Optic was 30% and at no control point a statistically significant difference from the original drug was revealed. A positive dynamic of visual acuity, static perimetry indices and optical coherence tomography was registered, showing n significant intergroup differences. This may indicate that the drugs have an indirect neuroprotective effect. The adverse events included discomfort and redness of the bulbar conjunctiva, which were recorded in 7 out of 30 patients in the study group and in 6 out of 30 patients in the control group. All of them were mild and completely reversible. No serious or systemic adverse events were reported. Conclusion. Latanoprost-Optic has an efficacy comparable to that of the original latanoprost drug and has a comparable favorable safety profile.
Alpha2-macroglobulin (α2-MG) is a multifunctional glycoprotein. Due to the variety of its functions there can be several ways of its involvement in the pathogenesis of the glaucomatous optic neuropathy, including neuroinflammation, amyloid deposition, neurotoxicity. It is known that α2-MG level in aqueous humor is increased in glaucoma but there is scant information about its concentration in blood and tear fluid.Purpose. To determine the α2-MG activity in tear fluid and blood serum of glaucoma patients to broaden of understanding of its role in the pathogenesis of glaucoma and to estimate its informativity for the characterization of the disease clinical course.Methods. Tear fluid was collected from 21 patients with primary open-angle glaucoma and 17 healthy adults. Activity of α2-MG was measured enzymatically with BAPNA as a substrate.Results. Activity of α2-MG in tears was 20 times lower than in blood serum. In healthy controls it was 4.66 ± 0.27 nmol / min×ml in tears and 92.35 ± 5.44 nmol / min×ml in blood. Totally in glaucoma patients it was 54 % higher than in controls in tears (р < 0.008), and 35 % higher in blood (р < 0.05). Particularly patients without pseudoexfoliative syndrome showed a significant α2-MG activity increase in tears (2 times) while in serum it was 67 % higher than in controls. In patients with pseudoexfoliative glaucoma α2-MG activity was not increased in tears nor in blood.Conclusion. Primary open-angle glaucoma without pseudoexfoliative syndrome cause the increase of α2-MG activity in tears and in blood in contrast with pseudoexfoliative glaucoma. This fact indicates that pathogenetic ways of these types of glaucoma are different. The increased α2-MG activity may be the risk factor for the development of glaucoma without pseudoexfoliative syndrome.
The aim of the investigation was to identify new biomechanical parameters characterizing elastic properties of the ocular corneoscleral shell and to determine their significance for estimating the risk of primary open-angle glaucoma (POAG) progression.Materials and Methods. The study involved 41 patients (43 eyes) aged 55 to 72 (mean age 64.0±4.0 years) with non-operated POAG, including 20 eyes with stage I POAG and 23 eyes with stage II, as well as 15 patients of the same age group with no eye pathology (except for age-related cataract) who served as control. The examination included Maklakov elastic tonometry with three different weights, differential Schiötz tonometry using a GlauTest 60 tomograph (Russia), optic nerve imaging using HRT3 (Germany), and static Humphrey (Germany) perimetry. All patients were re-examined 18 months after the initial examination.Results. The biomechanical parameters were calculated based on mathematical modeling using elastic tonometry and differential tonometry data according to the method proposed by the authors. The value of a new parameter, elastic rise coefficient γ M , characterizing mainly the rigidity of the cornea and determined using Maklakov elastic tonometry data averaged 0.88±0.20 mm Hg/g in stage I POAG and 0.80±0.04 mm Hg/g in stage II, whereas the control group showed an average of 0.86±0.07 mm Hg/g. At the same time, we revealed increase in the other biomechanical parameter, elastic rise coefficient γ S , characterizing mainly the rigidity of the sclera and determined according to Schiötz elastic tonometry data. Its value amounted to 1.65±0.25 mm Hg/g for stage I POAG and 1.88±0.13 mm Hg/g for stage II, with the mean of 1.47±0.10 mm Hg/g in the control group. It was found that with the value К=γ S /γ M (an index showing the individual ratio of scleral and corneal rigidity) increasing above the threshold level clinical signs of glaucomatous process progression were observed.Conclusion. The results indicate growing imbalance between biomechanical parameters of the sclera (γ S ) and the cornea (γ M ) during POAG development. The ratio of these parameters (K=γ S /γ M ) can serve as a measure of risk in progression of glaucomatous process related to the change in the state of the ocular corneoscleral shell.
Purpose: a comparative study of the efficacy and safety of the generic drug Dorzial Plus, an analogue of the original reference drug Cosopt®, in patients with primary open-angle glaucoma (POAG).Material and methods. The study involved 80 patients of both sexes aged 55–75 with newly diagnosed POAG of the initial and advanced stages with uncompensated intraocular pressure (IOP), of which 40 patients (study group) received Dorzial Plus and 40 patients (comparison group) received the reference drug (Cosopt®). Hypotensive efficacy of the drugs in both groups was assessed using a portable ophthalmic tonometer Icare PRO (Finland) by reducing IOP from the initial level after 1 week, 1 month and 3 months of treatment.Results. In both groups, the screening showed comparable average IOP values: 26.7 ± 3.2 mm Hg in the reference drug group and 27.4 ± 2.8 mm Hg in the Dorzial Plus group. After 1 week of therapy with Cosopt, IOP showed a significant decrease of 33% (reduction to 17.9 ± 3.2 mm Hg), while the group receiving Dorzial Plus demonstrated a 31% decrease (reduction to 18.9 ± 1.7 mm Hg). After 1 month of the instillation regimen, a slight increase in P0 (of about 3%) was recorded in both groups (increase to 18.7 ± 2.3 and 19.7 ± 2.0 mm Hg, respectively). By the end of the 3 months’ follow-up period, IOP decrease level with respect to the baseline remained practically the same, amounting to 30 and 29% (up to 18.6 ± 1.8 and 19.5 ± 2.3 mm Hg), respectively. The state of the ocular surface showed a slightly negative dynamics of tear film rupture time and OSDI index in the reference drug group, which could be observed throughout 3 months of therapy. In the study group, therapy with preservative-free drug containing a moisturizing agent (sodium hyaluronate) revealed a significantly changed OSDI index, manifesting itself in restructured severity of the evaluated features.Conclusion. Dorzial Plus reduces IOP in POAG patients by an average of 30% of the baseline, so that its hypotensive efficacy is comparable to the original fixed combination Cosopt. The tolerability analysis of the study drug demonstrates a significant positive dynamic of the state of the ocular surface as soon as 3 months after therapy start.
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