Clinical Research Directory

Effectiveness of Digital Defocus Vision Training With Low-Concentration Atropine on the Prevention and Control of Myopia in Children: A Clinical Study

Based on existing theories of myopia development and progression, our preliminary work has leveraged the features of virtual reality (VR) technology to digitally simulate myopic defocus signals through image-based emulation. Using ray-tracing techniques, we generated a constant amount of defocus on the corresponding retinal areas, employed a gradient defocus design combined with intelligent navigation to enhance defocus stimulation efficacy, and thereby developed a Digital Peripheral Defocus Training (DDVT) paradigm. In prior interventional studies, this training system demonstrated certain efficacy in controlling both axial length elongation and refractive error progression in pediatric subjects. Specifically, the control rate for refractive error progression exceeded 50%, reaching a level comparable to first-line clinical myopia control modalities, whereas the control rate for axial length elongation was approximately 45%, slightly lower than that of commonly used clinical interventions. The investigators hypothesize that this may be attributable to the paradigm's design being based solely on peripheral defocus theory, resulting in a relatively singular mechanism of action. In the present study, we combine digital defocus training via VR devices with low-dose atropine (primarily targeting the neurotransmitter-related theory and the scleral hypoxia theory), and compare this combination against conventional defocus-based interventions (peripheral defocus design spectacles). The aim is to evaluate the combined effect of this multi-pathway, multi-target myopia control strategy on axial length and refractive error control in myopic children. Primary Objective To compare the effect on axial length elongation control between two different combined intervention regimens in myopic children: 1. 0.02% atropine eye drops combined with daily wear of fully corrected Defocus Incorporated Multiple Segments (DIMS) spectacles; 2. DDVT combined with 0.02% atropine eye drops and daily wear of fully corrected DIMS spectacles. Through a 1-year follow-up, we will determine whether the change in axial length from baseline differs significantly between the two groups. Secondary Objectives Between-group differences: To compare the 1-year changes between the two groups (DDVT + atropine + DIMS vs. atropine + DIMS) in the following parameters: refractive error (spherical equivalent), accommodative facility, positive and negative relative accommodation (PRA/NRA), uncorrected visual acuity, best-corrected visual acuity, and intraocular pressure. Additionally, to analyse the associations among these between-group differences. Within-group changes: To evaluate the changes from baseline in each of the above parameters after 1 year of intervention within each group separately.

Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants

Childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. This condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. For this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. The objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at Mexican mothers with children under six months of age to increase the practice of Tummy Time and maintain the healthy weight of the infant compared to usual care. The methodology will be a pilot randomized clinical trial with randomization to the Experimental Group and Control Group, the intervention will be with a single-blind approach and repeated measurements. A non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in Mexico.

Prevention Workshop to Address Bullying Behaviors in Schools

This study, titled APACHES, is a cluster randomized controlled trial aimed at evaluating the effectiveness of a school-based prevention program, "Tous Épanouis à l'École" (TEAL), conducted by healthcare students as part of their mandatory public health service curriculum. The TEAL program consists of five interactive sessions focused on developing psychosocial skills (e.g., communication, empathy, collaboration) among elementary school students (grades CE2-CM1-CM2) in the Grenoble Academy. The primary objective is to assess whether the program reduces the prevalence of bullying behaviors (victims and/or aggressors) compared to standard preventive actions on unrelated themes. The study involves 36 classrooms across 18 schools, with data collected at three time points: before, one month after, and four months after the intervention. Secondary objectives include evaluating social proximity, altruistic behaviors, and qualitative perceptions from students, teachers, and facilitators.