Influence of non-osteoporotic treatments in patients on active anti-osteoporotic therapy: evidence from the OSTEOMED registry.

PURPOSE: To evaluate the effect of different non-osteoporotic drugs on the increase or decrease in the risk of incident fragility fractures (vertebral, humerus or hip) in a cohort of patients diagnosed with osteoporosis on active anti-osteoporotic therapy. METHODS: For this retrospective longitudinal study, baseline and follow-up data on prescribed non-osteoporotic treatments and the occurrence of vertebral, humerus or hip fractures in 993 patients from the OSTEOMED registry were analyzed using logistic regression models. The drugs evaluated with a possible beneficial effect were thiazides and statins, while the drugs evaluated with a possible harmful effect were antiandrogens, aromatase inhibitors, proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, GnRH agonists, thyroid hormones, and oral and inhaled corticosteroids. RESULTS: Logistic regression analyses indicated that no treatment significantly improved fracture risk, with the only treatments that significantly worsened fracture risk being letrozole (OR = 0.18, p-value = 0.03) and oral corticosteroids at doses ≤ 5 mg/day (OR = 0.16, p-value = 0.03) and > 5 mg/day (OR = 0.27, p-value = 0.04). CONCLUSION: The potential beneficial or detrimental effects of the different drugs evaluated on fracture risk are masked by treatment with anabolic or antiresorptive drugs that have a more potent action on bone metabolism, with two exceptions: letrozole and oral corticosteroids. These findings may have important clinical implications, as patients receiving these treatments are not fully protected by bisphosphonates, which may imply the need for more potent anti-osteoporotic drugs such as denosumab or teriparatide.

Randomised placebo-controlled clinical trial evaluating the impact of a new visual rehabilitation program on neuroadaptation in patients implanted with trifocal intraocular lenses.

PURPOSE: To evaluate the efficacy of a new visual training program for improving the visual function in patients implanted with trifocal intraocular lenses (IOLs). METHODS: Randomised placebo-controlled clinical trial enrolling 60 subjects (age, 47-75 years) undergoing cataract surgery with implantation of trifocal diffractive IOL. Home-based active visual training was prescribed immediately after surgery to all of them (20 sessions, 30 min): 31 subjects using a serious game based on Gabor patches (study group) and 29 using a placebo software (placebo group). Visual acuity, contrast sensitivity (CS), and perception of visual disturbances (QoV questionnaire) were evaluated before and after training. Likewise, in a small subgroup, resting-state functional magnetic resonance imaging (rs-fMRI) analysis was performed. RESULTS: No significant differences were found between groups in compliance time (p = 0.70). After training, only significant improvements in monocular uncorrected intermediate visual acuity were found in the study group (p ≤ 0.01), although differences between groups did not reach statistical significance (p ≥ 0.11). Likewise, significantly better binocular far CS values were found in the study group for the spatial frequencies of 6 (p = 0.01) and 12 cpd (p = 0.03). More visual symptoms of the QoV questionnaire experienced a significant change in the level of bothersomeness in the study group. Rs-fMRI revealed the presence significant changes reflecting higher functional connectivity after the training with the serious game. CONCLUSIONS: A 3-week visual training program based on the use of Gabor patches after bilateral implantation of trifocal diffractive IOLs may be beneficial for optimising the visual function, with neural changes associated suggesting an acceleration of neuroadaptation. Trial registration ClinicalTrials.gov, NCT04985097. Registered 02 August 2021, https://clinicaltrials.gov/(NCT04985097 ).

Comorbidity and osteoporotic fracture: approach through predictive modeling techniques using the OSTEOMED registry.

PURPOSE: To examine the response to anti-osteoporotic treatment, considered as incident fragility fractures after a minimum follow-up of 1 year, according to sex, age, and number of comorbidities of the patients. METHODS: For this retrospective observational study, data from baseline and follow-up visits on the number of comorbidities, prescribed anti-osteoporotic treatment and vertebral, humerus or hip fractures in 993 patients from the OSTEOMED registry were analyzed using logistic regression and an artificial network model. RESULTS: Logistic regression showed that the probability of reducing fractures for each anti-osteoporotic treatment considered was independent of sex, age, and the number of comorbidities, increasing significantly only in males taking vitamin D (OR = 7.918), patients without comorbidities taking vitamin D (OR = 4.197) and patients with ≥ 3 comorbidities taking calcium (OR = 9.412). Logistic regression correctly classified 96% of patients (Hosmer-Lemeshow = 0.492) compared with the artificial neural network model, which correctly classified 95% of patients (AUC = 0.6). CONCLUSION: In general, sex, age and the number of comorbidities did not influence the likelihood that a given anti-osteoporotic treatment improved the risk of incident fragility fractures after 1 year, but this appeared to increase when patients had been treated with risedronate, strontium or teriparatide. The two models used classified patients similarly, but predicted differently in terms of the probability of improvement, with logistic regression being the better fit.

Pilot Study Assessing the Safety and Acceptance of a Novel Virtual Reality System to Improve Visual Function.

PURPOSE: To assess the feasibility of the clinical use of a novel Virtual Reality (VR) training software designed to be used for active vision therapy in amblyopic patients by determining its preliminary safety and acceptance on the visual function of healthy adults. METHODS: Pilot study enrolling 10 individuals (3 men, 7 women, mean age: 31.8 ± 6.5 years) with a best-corrected visual acuity (BCVA) of ≥ .90 (decimal) in both eyes were evaluated before and after 20 minutes of exposure to the NEIVATECH VR system using the HTC Vive Pro Eye head mounted display. Visual function assessment included near (40 cm) and distance (6 m) cover test (CT), stereopsis, binocular accommodative facility (BAF), near point of convergence (NPC), near point of accommodation (NPA), accommodative-convergence over accommodation (AC/A) ratio and positive and negative fusional vergences. Safety was assessed using the VR Sickness Questionnaire (VRSQ) and acceptance using the Technology Acceptance Model ;(TAM). Changes in all these variables after VR exposure were analyzed. RESULTS: Short-term exposure to the NEIVATECH VR system only induced statistically significant changes in distance phoria (p = .016), but these changes were not clinically relevant. No significant changes were observed in VRSQ oculo-motricity and disorientation scores after exposure (p = .197 and .317, respectively). TAM scores showed a good acceptance of the system in terms of perceived enjoyment and perceived ease of use, although some concerns were raised in relation to the intention-to-use domain. CONCLUSION: Exposure to the NEIVATECH VR system does not seem to adversely affect the visual function in healthy adults and its safety and acceptance profile seems to be adequate for supporting its potential use in other populations, such as amblyopic patients.

Amblyopia Treatment through Immersive Virtual Reality: A Preliminary Experience in Anisometropic Children.

The use of digital devices provides a wide range of possibilities for measuring and improving visual function, including concepts such as perceptual learning and dichoptic therapy. Different technologies can be used to apply these concepts, including, in recent years, the introduction of virtual reality (VR) systems. A preliminary experience in treating anisometropic amblyopia through an immersive VR device and using prototype software is described. A total of 4 children were treated by performing 18 office-based sessions. Results showed that distance VA in amblyopic eyes remained constant in two subjects, whereas the younger subjects improved after the training. Near VA improved in three subjects. All subjects showed an increase in the stereopsis of at least one step, with three subjects showing a final stereopsis of a 60 s arc. A total of three subjects showed an increase of approximately 0.5 CS units for the spatial frequency of 3 cpd after the training. Results from this pilot study suggest that visual training based on perceptual learning through an immersive VR environment could be a viable treatment for improving CS, VA, and stereopsis in some children with anisometropic amblyopia. Future studies should support these preliminary results.

Randomized Controlled Trial Evaluating the Benefit of a Novel Clinical Decision Support System for the Management of COVID-19 Patients in Home Quarantine: A Study Protocol.

(1) Background: We present the protocol of a randomized controlled trial designed to evaluate the benefit of a novel clinical decision support system for the management of patients with COVID-19. (2) Methods: The study will recruit up to 500 participants (250 cases and 250 controls). Both groups will receive the conventional telephone follow-up protocol by primary care and will also be provided with access to a mobile application, in which they will be able to report their symptoms three times a day. In addition, patients in the active group will receive a wearable smartwatch and a pulse oximeter at home for real-time monitoring. The measured data will be visualized by primary care and emergency health service professionals, allowing them to detect in real time the progression and complications of the disease in order to promote early therapeutic interventions based on their clinical judgement. (3) Results: Ethical approval for this study was obtained from the Drug Research Ethics Committee of the Valladolid East Health Area (CASVE-NM-21-516). The results obtained from this study will form part of the thesis of two PhD students and will be disseminated through publication in a peer-reviewed journal. (4) Conclusions: The implementation of this telemonitoring system can be extrapolated to patients with other similar diseases, such as chronic diseases, with a high prevalence and need for close monitoring.

Visual perception alterations in COVID-19: a preliminary study.

AIM: To compare the visual perception (color and chromatic-achromatic contrast vision) of a small cohort of COVID-19 patients at the time of infection and after 6mo with that of a healthy population matched for sex and age. METHODS: A total of 25 patients (9 females, 16 males, mean age: 54±10y) with COVID-19 hospitalized in the COVID-19 Unit of the University Clinical Hospital of Valladolid were recruited for this preliminary study. Visual perception, as determined by monocular measurement of contrast sensitivity function (CSF) and color vision was assessed in each patient using the Optopad test. The results obtained were then compared with those of a sample of 16 age- and sex-matched healthy controls (5 females, 11 males, mean age: 50±6y) in which the same measurement procedure was repeated. Statistically significant differences between groups were assessed using the Mann-Whitney U test. Measurements were repeated after a minimum follow-up period of 6mo and statistically significant differences between the two time points in each group were assessed using the Wilcoxon signed rank test. RESULTS: Discrimination thresholds (color and chromatic-achromatic contrast vision) and their corresponding sensitivity, calculated as the inverse of the discrimination threshold, were evaluated. Analysis of the data revealed higher contrast threshold results (i.e., worse contrast sensitivity) in the COVID-19 group than in the control group for all spatial frequencies studied in the Optopad-CSF achromatic test and most of the spatial frequencies studied in the Optopad-CSF chromatic test for the red-green and blue-yellow mechanisms. In addition, color threshold results in the COVID-19 group were also significantly higher (i.e., worse color sensitivity) for almost all color mechanisms studied in the Optopad-Color test. At 6mo, most of the differences found between the groups were maintained despite COVID-19 recovery. CONCLUSION: The present results provide preliminary evidence that visual perception may be impaired in COVID-19, even when the infection has passed. Although further research is needed to determine the precise causes of this finding, analysis of CSF and color vision could provide valuable information on the visual impact of COVID-19.

Preliminary Evaluation of the Clinical Benefit of a Novel Visual Rehabilitation Program in Patients Implanted with Trifocal Diffractive Intraocular Lenses: A Blinded Randomized Placebo-Controlled Clinical Trial.

The authors of this study evaluated the potential benefit on visual performance of a novel 3 week visual rehabilitation program based on the use of Gabor patches in patients undergoing bilateral cataract surgery with the implantation of two models of trifocal diffractive intraocular lens (IOL). A total of 30 patients were randomly assigned to two groups: a study group (15 patients) that used a videogame based on Gabor patches and a placebo group (15 patients) that used a videogame without specific stimuli for improving visual performance. No statistically significant differences between groups were found in distance, intermediate, and near post-training visual acuity (p ≥ 0.15). Significantly better distance contrast sensitivity (CS) was found for the spatial frequencies of 6 (p = 0.02) and 12 cpd (p = 0.01) in the study group. Likewise, significantly better values of near CS were found in the study group compared to the placebo group for the spatial frequency of 1.5 cpd (p = 0.02). In conclusion, a 3 week visual rehabilitation program based on the use of Gabor patches in the immediate postoperative period after the bilateral implantation of trifocal diffractive IOLs seems to be beneficial for improving both distance and near visual performance achieved with the implant.

The Potential of Virtual Reality for Inducing Neuroplasticity in Children with Amblyopia.

In recent years, virtual reality (VR) has emerged as a new safe and effective tool for neurorehabilitation of different childhood and adulthood conditions. VR-based therapies can induce cortical reorganization and promote the activation of different neuronal connections over a wide range of ages, leading to contrasted improvements in motor and functional skills. The use of VR for the visual rehabilitation in amblyopia has been investigated in the last years, with the potential of using serious games combining perceptual learning and dichoptic stimulation. This combination of technologies allows the clinician to measure, treat, and control changes in interocular suppression, which is one of the factors leading to cortical alterations in amblyopia. Several clinical researches on this issue have been conducted, showing the potential of promoting visual acuity, contrast sensitivity, and stereopsis improvement. Indeed, several systems have been evaluated for amblyopia treatment including the use of different commercially available types of head mounted displays (HMDs). These HMDs are mostly well tolerated by patients during short exposures and do not cause significant long-term side effects, although their use has been occasionally associated with some visual discomfort and other complications in certain types of subjects. More studies are needed to confirm these promising therapies in controlled randomized clinical trials, with special emphasis on the definition of the most adequate planning for obtaining an effective recovery of the visual and binocular function.

Stimuli Characteristics and Psychophysical Requirements for Visual Training in Amblyopia: A Narrative Review.

Active vision therapy using perceptual learning and/or dichoptic or binocular environments has shown its potential effectiveness in amblyopia, but some doubts remain about the type of stimuli and the mode and sequence of presentation that should be used. A search was performed in PubMed, obtaining 143 articles with information related to the stimuli used in amblyopia rehabilitation, as well as to the neural mechanisms implied in such therapeutic process. Visual deficits in amblyopia and their neural mechanisms associated are revised, including visual acuity loss, contrast sensitivity reduction and stereopsis impairment. Likewise, the most appropriate stimuli according to the literature that should be used for an efficient rehabilitation of the amblyopic eye are described in detail, including optotypes, Gabor's patches, random-dot stimuli and Vernier's stimuli. Finally, the properties of these stimuli that can be modified during the visual training are discussed, as well as the psychophysical method of their presentation and the type of environment used (perceptual learning, dichoptic stimulation or virtual reality). Vision therapy using all these revised concepts can be an effective option for treating amblyopia or accelerating the treatment period when combining with patching. It is essential to adapt the stimuli to the patient's individual features in both monocular and binocular training.