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Ophthalmology Science 2024To assess the efficacy and safety of the PRIMA neurostimulation system with a subretinal microchip for improving visual acuity (VA) in patients with geographic atrophy...
OBJECTIVE
To assess the efficacy and safety of the PRIMA neurostimulation system with a subretinal microchip for improving visual acuity (VA) in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD) at 48-months postimplantation.
DESIGN
Feasibility clinical trial of the PRIMA subretinal prosthesis in patients with atrophic AMD, measuring best-corrected ETDRS VA (Clinicaltrials.govNCT03333954).
SUBJECTS
Five patients with GA, no foveal light perception, and VA of logarithm of the minimum angle of resolution (logMAR) 1.3 to 1.7 (20/400-20/1000) in their worse-seeing "study" eye.
METHODS
In patients subretinally implanted with a photovoltaic neurostimulation array containing 378 pixels of 100 μm in size, the VA was measured with and without the PRIMA system using ETDRS charts at 1 m. The system's external components, augmented reality glasses, and pocket computer provide image processing capabilities, including zoom.
MAIN OUTCOME MEASURES
Visual acuity using ETDRS charts with and without the system, as well as light sensitivity in the central visual field, measured by Octopus perimetry. Anatomical outcomes demonstrated by fundus photography and OCT up to 48 months postimplantation.
RESULTS
All 5 subjects met the primary end point of light perception elicited by the implant in the scotoma area. In 1 patient, the implant was incorrectly inserted into the choroid. One subject died 18 months postimplantation due to study-unrelated reasons. ETDRS VA results for the remaining 3 subjects are reported here. Without zoom, VA closely matched the pixel size of the implant: 1.17 ± 0.13 pixels, corresponding to a mean logMAR of 1.39, or Snellen of 20/500, ranging from 20/438 to 20/565. Using zoom at 48 months, subjects improved their VA by 32 ETDRS letters versus baseline (standard error 5.1) 95% confidence intervals (13.4, 49.9; < 0.0001). Natural peripheral visual function in the treated eye did not decline after surgery or during the 48-month follow-up period ( = 0.08).
CONCLUSIONS
Subretinal implantation of PRIMA in subjects with GA experiencing profound vision loss due to AMD is feasible and well tolerated, with no reduction of natural peripheral vision up to 48 months. Prosthetic central vision provided by photovoltaic neurostimulation enabled patients to reliably recognize letters and sequences of letters, and with zoom, it improved VA of up to 8 ETDRS lines.
FINANCIAL DISCLOSURES
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
PubMed: 38881600
DOI: 10.1016/j.xops.2024.100510 -
Journal of Social Work in End-of-life &... Jun 2024The perception of social support among patients with advanced diseases is influenced by various factors. The socio-cultural context of Bangladesh significantly shapes...
The perception of social support among patients with advanced diseases is influenced by various factors. The socio-cultural context of Bangladesh significantly shapes the experience of patients with advanced cancer and their perception of social support. This study's aim was to assess the perceived social support by these patients and investigate the factors that shape their perception. This cross-sectional study was conducted among 115 advanced cancer patients admitted to the palliative medicine department of a tertiary care hospital in Bangladesh. Perceived social support was measured by the Multidimensional Scale of Perceived Social Support (MSPSS). Perceived social support was moderate to high for most (74.7%) of the participants. The majority (97.4%) perceived moderate to high level of support from their families. The lowest level of support was perceived from friends (53%). Factors such as economic status, family size, companionship of children, and emotional support from spouses influenced the level of perceived social support. Social support is one of the important aspects of palliative care. Identifying the factors influencing the perception of social support among cancer patients is essential for palliative care professionals to effectively address their care needs.
PubMed: 38879815
DOI: 10.1080/15524256.2024.2367004 -
Human Nature (Hawthorne, N.Y.) Jun 2024Humans have undergone a long evolutionary history of violent agonistic exchanges, which would have placed selective pressures on greater body size and the psychophysical...
Humans have undergone a long evolutionary history of violent agonistic exchanges, which would have placed selective pressures on greater body size and the psychophysical systems that detect them. The present work showed that greater body size in humans predicted increased knockout power during combative contests (Study 1a-1b: total N = 5,866; Study 2: N = 44 openweight fights). In agonistic exchanges reflective of ancestral size asymmetries, heavier combatants were 200% more likely to win against their lighter counterparts because they were 200% more likely to knock them out (Study 2). Human dominance judgments (total N = 500 MTurkers) accurately tracked the frequency with which men (N = 516) knocked out similar-sized adversaries (Study 3). Humans were able to directly perceive a man's knockout power because they were attending to cues of a man's body size. Human dominance judgments-which are important across numerous psychological domains, including attractiveness, leadership, and legal decision-making-accurately predict the likelihood with which a potential mate, ally, or rival can incapacitate their adversaries.
PubMed: 38878141
DOI: 10.1007/s12110-024-09473-7 -
Journal of Neuropsychology Jun 2024Knowledge of the body size is intricately tied to multisensory integration processes that rely on the dynamic interplay of top-down and bottom-up mechanisms. Recent...
Knowledge of the body size is intricately tied to multisensory integration processes that rely on the dynamic interplay of top-down and bottom-up mechanisms. Recent years have seen the development of passive sensory stimulation protocols aimed at investigating the modulation of various cognitive functions, primarily inducing perceptual learning and behaviour change without the need for extensive training. Given that reductions in sensory input have been associated with alterations in body size perception, it is reasonable to hypothesize that increasing sensory information through passive sensory stimulation could similarly influence the perception of the size of body parts. The primary aim of this study was to investigate the potential modulatory effects of passive sensory stimulation on the perception of hand and face size in a group of young adults. Passive sensory stimulation effectively modulated the size representation of the stimulated hand, supporting the notion that access to somatosensory and proprioceptive information is prioritised for the hands but may not extend to the face. Increased somatosensory input resulted in a reduction of distortion, providing evidence for bottom-up modulation of size representation. Passive sensory stimulation can induce subjective changes in body size perception without the need for extensive training. This paradigm holds promise as a potential alternative for modulating distorted size representation in individuals with body representational deficits.
PubMed: 38877675
DOI: 10.1111/jnp.12379 -
Journal of Clinical and Experimental... Jun 2024The rod and frame test (RFT), a measure of field dependence-independence, recently has reemerged as a measure of research interest and potential diagnostic value in... (Review)
Review
BACKGROUND
The rod and frame test (RFT), a measure of field dependence-independence, recently has reemerged as a measure of research interest and potential diagnostic value in neuropsychology. In the standard RFT, the subject experiences offsetting visual cues from a frame surrounding an embedded rod, while the subject's postural/vestibular cues provide the sense of verticality as the subject attempts to set the rod to vertical. The paper shows that RFTs not adhering to RFT parameters can reduce the test's visual framework impact experienced by the subject. Comparisons of neuropsychological studies will highlight that correct adherence to RFT testing conditions can strengthen RFT effects.
METHOD
This review presents the parameters that have been studied which impact on subject performance on the RFT. It identifies how computer administered RFTs have been applied to enhance the study of the RFT parameters and make the RFT more accessible to the study of different diagnostic groups. The article also critiques studies by identifying how the RFT's parameters, study's design and statistical analysis may have diminished identifying the full effects of the RFT experience.
RESULTS
Parameters impacting judgments of verticality of the rod can include: perceived size of rod and frame, the gap between the ends of the rod and surrounding frame, presentation of the rod within an encompassing 3D visual framework that visually blocks out the surrounding environment, a dark room, instructions stressing egocentric vs allocentric strategies, double frame surrounding the rod to assess global perception effects, etc. Details are presented how gap size likely affected results in neuropsychology studies. Potentially, these and other experiments may be studied using computer administered RFTs.
CONCLUSIONS
Based on the descriptions of computer administered RFTs, this article suggested that incorporating these technologies can provide better understanding underlying the RFT, and in turn, understanding neuropsychology processes.
PubMed: 38873989
DOI: 10.1080/13803395.2024.2356297 -
Frontiers in Psychology 2024How does the human visual system assess the separation between pairs of stimuli in a frontal plane? According to the (or subtractive) view the system finds the...
How does the human visual system assess the separation between pairs of stimuli in a frontal plane? According to the (or subtractive) view the system finds the difference between the positions of the stimuli in a localization system. According to the (or additive) view the system finds the number of instances of a distance unit lying between representations of the stimuli. Critically, position is explicitly represented under the direct view, with separation being derived from position. Position is not explicitly represented under the indirect view; separation is consequently inferred by counting an internal unit of distance. Recent results favor the indirect over the direct view of separation assessment. Dissociations between assessments of separation and position, various context effects in the assessment of separation, and suggestions that position information is not cleanly accessed argue against the direct view. At the same time, various context effects in separation assessment argue for the indirect view. Recent findings regarding the brain bases of vision are consistent with the indirect view. In short, recent results suggest that assessing the separation between two frontal stimuli involves integrating distance units between representations of the stimuli.
PubMed: 38873519
DOI: 10.3389/fpsyg.2024.1410297 -
Trials Jun 2024The TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures...
Statistical analysis plan for the TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation of potentially clinically significant prostate cancer) multicentre randomised controlled trial.
BACKGROUND
The TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures in terms of detection of clinically significant prostate cancer (PCa). This article describes the statistical analysis plan (SAP) for the TRANSLATE randomised controlled trial (RCT).
METHODS/DESIGN
TRANSLATE is a parallel, superiority, multicentre RCT. Biopsy-naïve men aged ≥ 18 years requiring a prostate biopsy for suspicion of possible PCa are randomised (computer-generated 1:1 allocation ratio) to one of two biopsy procedures: transrectal (TRUS) or local anaesthetic transperineal (LATP) biopsy. The primary outcome is the difference in detection rates of clinically significant PCa (defined as Gleason Grade Group ≥ 2, i.e. any Gleason pattern ≥ 4 disease) between the two biopsy procedures. Secondary outcome measures are th eProBE questionnaire (Perception Part and General Symptoms) and International Index of Erectile Function (IIEF, Domain A) scores, International Prostate Symptom Score (IPSS) values, EQ-5D-5L scores, resource use, infection rates, complications, and serious adverse events. We describe in detail the sample size calculation, statistical models used for the analysis, handling of missing data, and planned sensitivity and subgroup analyses. This SAP was pre-specified, written and submitted without prior knowledge of the trial results.
DISCUSSION
Publication of the TRANSLATE trial SAP aims to increase the transparency of the data analysis and reduce the risk of outcome reporting bias. Any deviations from the current SAP will be described and justified in the final study report and results publication.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number ISRCTN98159689, registered on 28 January 2021 and registered on the ClinicalTrials.gov (NCT05179694) trials registry.
Topics: Humans; Male; Prostatic Neoplasms; Biopsy; Multicenter Studies as Topic; Anesthesia, Local; Data Interpretation, Statistical; Cost-Benefit Analysis; Neoplasm Grading; Perineum; Randomized Controlled Trials as Topic; Equivalence Trials as Topic; Prostate; Rectum; Predictive Value of Tests
PubMed: 38872174
DOI: 10.1186/s13063-024-08224-4 -
Scientific Reports Jun 2024Previous studies have identified differences in sensitivity characteristics between color discrimination and perception of suprathreshold color differences. However, it...
Previous studies have identified differences in sensitivity characteristics between color discrimination and perception of suprathreshold color differences. However, it remains highly unclear how color difference sensitivity changes with increasing magnitudes of color difference along various color hues. This study aimed to quantify the sensitivity transition across various magnitudes of color differences and uncover the underlying mechanisms. Color discrimination sensitivities were measured using an adaptive staircase method for 32 isoluminant pedestal colors in the u'v' chromaticity diagram. For suprathreshold color differences, we employed the Maximum Likelihood Difference Scaling (MLDS) method to measure sensitivity to various color difference levels for the same 32 colors. Our findings confirmed the differences in sensitivity characteristics between discrimination and suprathreshold color difference perception. Furthermore, we observed increased sensitivities at many color category boundaries in suprathreshold color difference perception. By investigating the relation between the category effects and the color difference size levels through a model simulation, our findings suggest that the influence of color categories on the perception of color differences may become more pronounced as the magnitude of color differences increases.
PubMed: 38871867
DOI: 10.1038/s41598-024-64215-0 -
ENeuro Jun 2024In human adults, multiple cortical regions respond robustly to faces, including the occipital face area (OFA) and fusiform face area (FFA), implicated in face...
In human adults, multiple cortical regions respond robustly to faces, including the occipital face area (OFA) and fusiform face area (FFA), implicated in face perception, and the superior temporal sulcus (STS) and medial prefrontal cortex (MPFC), implicated in higher level social functions. When in development does face selectivity arise in each of these regions? Here, we combined two awake infant functional magnetic resonance imaging (fMRI) datasets to create a sample size twice the size of previous reports (n = 65 infants, 2.6-9.6 months). Infants watched movies of faces, bodies, objects, and scenes while fMRI data were collected. Despite variable amounts of data from each infant, individual subject whole-brain activation maps revealed responses to faces compared to non-face visual categories in the approximate location of OFA, FFA, STS, and MPFC. To determine the strength and nature of face selectivity in these regions, we used cross-validated functional region of interest (fROI) analyses. Across this larger sample size, face responses in OFA, FFA, STS, and MPFC were significantly greater than responses to bodies, objects, and scenes. Even the youngest infants (2-5 months) showed significantly face-selective responses in FFA, STS, and MPFC, but not OFA. These results demonstrate that face selectivity is present in multiple cortical regions within months of birth, providing powerful constraints on theories of cortical development. Social cognition often begins with face perception. In adults, several cortical regions respond robustly to faces, yet little is known about when and how these regions first arise in development. To test whether face selectivity changes in the first year of life, we combined two datasets, doubling the sample size relative to previous reports. In the approximate location of the fusiform face area (FFA), superior temporal sulcus (STS), and medial prefrontal cortex (MPFC) but not occipital face area (OFA), face selectivity was present in the youngest group. These findings demonstrate that face-selective responses are present across multiple lobes of the brain very early in life.
PubMed: 38871455
DOI: 10.1523/ENEURO.0117-24.2024 -
Food Chemistry May 2024κ-Carrageenan (CG) was employed to mask the bitterness induced by 50% KCl in surimi gels to achieve salt reduction and gel performance improvement. The combination of...
κ-Carrageenan (CG) was employed to mask the bitterness induced by 50% KCl in surimi gels to achieve salt reduction and gel performance improvement. The combination of KCl and CG (KCl + CG) yielded the increased textural characteristics and water-holding capacity (WHC) of surimi gels and facilitated the transition of free water to immobilized water. In addition, the KCl + CG supplement increased the turbidity and particle size of myofibrillar protein (MP) sols but decreased the surface hydrophobicity in a dose-dependent manner. The hydrophobic interactions and disulfide bonds played crucial roles in maintaining the stability of MP gels. The specific binding of potassium ions to the sulfate groups of CG limited the release and diffusion of potassium ions from the surimi gels during oral processing, effectively masking the bitterness perception and maintaining the saltiness perception. This study provides a promising strategy to reduce the utilization of sodium salt in surimi products.
PubMed: 38870800
DOI: 10.1016/j.foodchem.2024.139859