Numerous publications have documented the results of clinical trials investigating the use of Retinalamin in patients with various optic nerve and retinal diseases. Retinalamin has been shown to have therapeutic effects when administered by various routes at a dose of 5–10 mg for 10 days. Positive effects have been documented with Retinalamin delivered parabulbarly, subconjunctivally, into the sub-Tenon’s space, endolymphatically, intramuscularly, and by endonasal electrophoresis. To document the effects, the authors used the results of visometry, perimetry, regional ocular hemodynamic studies, and objective electrophysiological and morphometric study parameters. The most methodologically sound clinical trial designs and a high methodological standard characterize studies investigating the effects of Retinalamin in patients with open-angle glaucoma and age-related macular degeneration. A shortcoming of many other studies is the absence or insufficiently designed control group, which reduces the significance of the obtained results. Increased efficacy of Retinalamin has been noted when used in combination with other treatment methods. Given this, it is advisable to focus research on two areas: small, well-designed, clearly defined studies with a limited objective, supported by a strong evidence base, and fundamental research into the mechanisms of Retinalamin’s effects on retinal metabolism, structure, and function.
Purpose. To compare the dynamics of functional parameters of the macular area in patients with dry and wet forms of age-related macular degeneration (AMD) during 24-month Retinalamin therapy using microperimetry (MP). Materials and methods. The study included 21 patients with intermediate dry AMD in one eye and wet AMD in the fellow eye. Patients were randomized into two groups: Group 1 (Retinalamin, n = 11, 22 eyes) and Group 2 (placebo, n = 10, 20 eyes). Microperimetry was performed using the MP-3 Nidek device (Japan) with the threshold macular program Macula 20_deg, testing 76 points within 2 to 20° from the fixation point, using a 0.43° stimulus (Goldmann III) of 200 ms duration and a 4–2 (fast) threshold strategy. The following parameters were analyzed: mean threshold retinal sensitivity (Ms, dB), fixation sensitivity (dB), presence of absolute and relative scotomas, and fixation stability. The follow-up period was 720 days (visits on days 90, 180, 270, 360, 450, 540, and 720). Results. In dry AMD, the Retinalamin group showed an increase in Ms of +3.27 ± 1.03 dB (p < 0.001), while the placebo group showed a decrease of –4.14 ± 2.11 dB (p = 0.002). In wet AMD, the Retinalamin group demonstrated a positive trend in Ms, but the increase was not statistically significant (p = 0.302), whereas the placebo group showed a decrease of –3.57 ± 0.94 dB (p = 0.002). The between-group difference in deltas reached 7.41 dB (d = 4.46, p < 0.001) in dry AMD and 5.57 dB (d = 3.93, p < 0.001) in wet AMD. The dynamics of fixation sensitivity in dry AMD largely mirrored those described for Ms. In the Retinalamin group, the increase was statistically significant at every visit starting from day 90 (all p < 0.001), indicating an early and stable effect. In dry AMD, fixation stability remained at 100 % in the Retinalamin group throughout the entire follow-up, with no eye showing loss of stable fixation. In the placebo group with dry AMD, stability decreased from 100 to 90 % by day 450. In wet AMD, the baseline level of stable fixation was lower (72.7 and 70.0 %); however, in the Retinalamin group, the proportion of eyes with stable fixation increased to 90.9 % by day 270, whereas in the placebo group it decreased to 50.0 %. The proportion of eyes without relative scotomas in the Retinalamin group increased from 27.3 to 100.0 % (p = 0.002) in dry AMD, and from 0.0 to 18.2 % in wet AMD; in the placebo group, relative scotomas were present in all eyes by day 180. Conclusion. Retinalamin therapy over 24 months provides a statistically significant increase in retinal sensitivity in dry AMD. All final deltas were positive and highly significant (p ≤ 0.002). In wet AMD, a trend toward improved mean retinal sensitivity was observed, and none of the patients receiving Retinalamin showed progression of the disease by the end of the follow-up period. The drug prevents the progression of functional defects, promotes regression of relative scotomas, and stabilizes fixation. In the placebo group, both forms showed progressive deterioration of both parameters (p < 0,05). These findings support the inclusion of Retinalamin in comprehensive AMD therapy with objective efficacy monitoring using MP.
Positive results of clinical trials (CIs) on the use of Retinalamin in patients with various diseases of the optic nerve and retina have been documented in the literature. To improve the objectivity of the study results and minimize bias, we conducted a randomized controlled clinical trial, the design of which included the formation of parallel groups treated with Retinalamin and placebo. The purpose of the study was to evaluate the dynamics of electroretinography (ERG) parameters in patients with dry and wet age-related macular degeneration (AMD) over two years during “Retinalamin” therapy. Material and methods. The study included 21 patients with eаrly or intermediate stage of dry AMD in one eye and wet AMD in the other eye. Patients were randomly divided into 2 groups: main (“Retinalamin”) and control (placebo) groups. Participants received the drugs intramuscularly (a total of 8 courses of 10 days with an interval of 90 days). Cone ERG (ISCEV), multifocal ERG (mfERG) and macular ERG (MERG) were recorded dynamically. The observation period was 720 days (2 years) with repeat ERG at 90, 180, 270, 360, 540 and 720 days after the start of CI. A comprehensive statistical analysis was used to evaluate the ERG results in all groups and for intergroup comparison. Results. The therapeutic effect of “Retinalamin” was detected in eyes with both dry and wet AMD. In the dry AMD subgroup, the effect was more pronounced and for a larger number of ERG parameters. The stability of the effect was confirmed by the results of the Friedman analysis with the Bonferroni correction and in linear mixed models. For most parameters, the proportion of patients who achieved the specified threshold values was higher in the “Retinalamin” group. Conclusion. A statistically significant advantage of “Retinalamin” over placebo was demonstrated for most parameters. The effect size (“large”), based on Cohen’s d coefficients for the amplitude density and latency of the P1 component for all mfERG rings, and the amplitude and latency of the a- and b-MERG waves, indicates a clinically significant effect of “Retinalamin”.
Lacrimal gland (LG) neoplasms vary in biological aggressiveness and prognosis, but often present with similar clinical features. Instrumental methods offer limited and nonspecific opportunities for differential diagnosis. Histological examination of tumor biopsy material remains the diagnostic gold standard. Despite published data, no consensus has been reached on the optimal treatment strategy for these patients. Preoperative noninvasive differentiation between malignant and benign LG neoplasms is therefore essential for choosing patient management, including the need, timing, and extent of surgery, which directly affects vital prognosis. We describe a rare case of primary ductal adenocarcinoma of the LG that for a long time mimicked a benign cystic lesion, and present the clinical, instrumental, and morphological findings.
Postoperative follow-up is an important element of the system for ensuring the safety and satisfaction of cataract patients. Existing approaches to the regulation of follow-up time do not allow to fully implement the strategy of early detection of postoperative complications, which requires the search for new solutions and complex evaluation of their effectiveness. Purpose : to improve the safety of cataract surgery by optimizing the postoperative follow-up. Materials and methods. A comparative cohort study in 2 groups of patients undergoing cataract surgery included 1951 patients in the main group and 2436 patients in the control group. In the control group of patients, the examination was scheduled within the terms regulated by the clinical recommendations on the 1st, 7rd, 28th day after the intervention. In the main group of patients, the second visit was scheduled on the 3rd day after surgery. The main outcome for assessing the efficacy of the follow-up regimens was the early detection of postoperative complications. Additional efficacy criteria were the visual acuity values after cataract phacoemulsification compared to the control group. Results. Clinical and functional outcomes in both groups did not differ with respect to visual acuity and intraocular pressure parameters before and after surgery (p > 0.05), demonstrating the achievement of a best corrected visual acuity (BCVA) of 0.9 ± 0.2 at 7 days after surgery. A visit at 3 days postoperatively significantly increased the probability of early detection of acute postoperative endophthalmitis (p = 0.018). As a result of endophthalmitis treatment, patients in the main group had an BCVA ³ 0.3, patients in the control group £ 0.2. Conclusions . Optimization of the monitoring regime of patients after surgery includes shifting the examination period from 7 to 3 days after the procedure, which provides a statistically significant reduction of the risks of late diagnosis (more than 1 day after manifestation) and improves the results of acute postoperative endophthalmitis treatment, thus increasing the safety of cataract surgery.
