Patching in Children With Unilateral Congenital Cataract and Child Functioning and Parenting Stress.

Importance: Parents may be concerned about the adverse outcomes of occlusion therapy in children treated for unilateral congenital cataract (UCC). Objective: To determine whether occlusion therapy in children treated for UCC with poor visual outcomes is negatively associated with poorer child and/or family functioning. Design, Setting, and Participants: This cohort study was conducted in 2023 using data collected between 2006 and 2016 in the Infant Aphakia Treatment Study (IATS). IATS participants with a visual acuity (VA) of 20/200 or worse were included. Statistical analysis was performed from July 2022 to October 2023. Exposure: Caregivers reported the mean daily minutes of patching during the 12 months prior to the VA assessment at 4.5 years of age. Patching was categorized as minimal (<15 minutes per day), moderate (15 to <120 minutes per day), or extensive (≥120 minutes per day). Main Outcome Measures: At 4.25 and 10.5 years of age, caregivers reported stress associated with the parenting role using the Parenting Stress Index and the Ocular Treatment Index and child behavior problems using the Achenbach Child Behavior Checklist. Motor skills were assessed at age 54 months using the Movement Assessment Battery for Children-Second Edition. Children completed the Harter Self-Perception Profile for Children at age 10.5 years. One-way analysis of variance and χ2 tests were used to compare outcomes by amount of patching. Results: Patching data were available for 47 of 53 children (88.7%) with a VA of 20/200 or worse. Among these 47 children with patching data included in the study, 20 (42.5%) were female, 27 (57.5%) were male, 12 (25.5%) were reported to have been patched fewer than 15 minutes per day, 11 (23.4%) were patched 16 to 119 minutes per day, and 24 (51.1%) were patched at least 120 minutes per day. Parenting stress, child behavior problems, motor functioning, and child self-perception were similar in all groups. For example, after adjusting for gender and insurance status, there was a nonsignificant difference between mean stress scores of 11.0 (95% CI, -4.5 to 26.5) points for parents who reported minimal patching vs parents who reported patching at least 120 minutes per day, and there was no significant difference in children's report of their global self-worth (0.0 [95% CI, -0.4 to 0.3] points). Conclusions and Relevance: Occlusion therapy was not negatively associated with family or child functioning. Although the sample size was limited, these results do not support changes to the current practice guidelines.

Evaluation of a carepartner-integrated telehealth gait rehabilitation program for persons with stroke: study protocol for a feasibility study.

BACKGROUND: Despite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this study is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility. METHODS: This two-phased design will determine the feasibility of CARE-CITE-Gait, a novel intervention that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-h home visits for dyad collaborative goal setting. In phase I, content validity, usability, and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In phase II, feasibility (based on measures of recruitment, retention, intervention adherence, and safety) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, quasi-experimental design with repeated measures (two baseline visits 1 week apart, posttest, and 1-month follow-up) with 15 carepartner and stroke survivor dyads. Outcome data collectors will be blinded. Outcomes include psychosocial variables (family conflict surrounding stroke recovery, strain, autonomy support, and quality of life) collected from carepartners and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors. DISCUSSION: The findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05257928. Registered 25 February 2022. TRIAL STATUS: This trial was registered on ClinicalTrials.gov (NCT05257928) on March 25, 2022. Recruitment of participants was initiated on May 18, 2022.

Neighborhood socioeconomic disadvantage measures in rehabilitation clinical trials: Lessons learned in recruitment.

PURPOSE: The Area Deprivation Index (ADI) measures the relative disadvantage of an individual or social network using US Census indicators. Although a strong re-hospitalization predictor, ADI has not been routinely incorporated into rehabilitation research. The purposes of this paper are to examine the use of ADI related to study recruitment, association with carepartner psychosocial factors, and recruitment strategies to increase participant diversity. METHODS: Descriptive analysis of baseline data from a pilot stroke carepartner-integrated therapy trial. Participants were 32 carepartners (N = 32; 62.5 % female; mean age 57.8 ± 13.0 years) and stroke survivors (mean age (60.6 ± 14.2) residing in an urban setting. Measures included ADI, Bakas Caregiver Outcome Scale, Caregiver Strain Index, and Family Assessment Device. RESULTS: Most carepartners were Non-Hispanic White participants (61.3 %), part or fully employed (43 %), with >$50,000 (67.7 %) income, and all had some college education. Most stroke survivors were Non-Hispanic White participants (56.3 %) with some college (81.3 %). Median ADI state deciles were 3.0 (interquartile range 1.5-5, range 1-9), and mean national percentiles were 41.7 ± 23.5 with only 6.3 % of participants from the most disadvantaged neighborhoods. For the more disadvantaged half of the state deciles, the majority were Black or Asian participants. No ADI and carepartner factors were statistically related. CONCLUSIONS: The use of ADI data highlighted a recruitment gap in this stroke study, lacking the inclusivity of participants from disadvantaged neighborhoods and with lower education. Using social determinants of health indicators to identify underrepresented neighborhoods may inform recruitment methods to target marginalized populations and broaden the generalizability of clinical trials.

Ameliorating Racial Disparities in Vascular Risk Factor Management With Aggressive Medical Management in the SAMMPRIS Trial.

BACKGROUND: The WASID trial (Warfarin-Aspirin Symptomatic Intracranial Disease) and the SAMMPRIS trial (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) evaluated optimal management of symptomatic intracranial atherosclerotic stenosis. The aim of this retrospective, observational study was to determine whether aggressive medical management used in the SAMMPRIS trial ameliorated disparities in risk factor control between Black and non-Black patients. METHODS: The SAMMPRIS trial was a randomized controlled trial that enrolled patients with symptomatic intracranial atherosclerotic stenosis between November 2008 and April 2011. The frequency of risk factors at study entry (baseline) and mean levels of systolic blood pressure, diastolic blood pressure, LDL (low-density lipoprotein), hemoglobin A1c, and exercise level (quantified by physician-based assessment and counseling for exercise score) at baseline and at 1 year of follow-up were compared between Black (n=104) versus non-Black patients (n=347). RESULTS: Significant differences at baseline in Black patients (listed first) versus non-Black patients were age (57.5 versus 61.0 years; P=0.004), hypertension (95.2% versus 87.5%; P=0.027), diabetes (52.9% versus 39.7%; P=0.017), mean diastolic blood pressure (82.4 versus 79.5 mm Hg; P=0.035), and mean physician-based assessment and counseling for exercise score (2.7 versus 3.3; P=0.002). The mean diastolic blood pressure and mean physician-based assessment and counseling for exercise scores at 1 year in Black versus non-Black patients were 74.7 versus 75.5 mm Hg (P=0.575) and 4.2 versus 4.1 (P=0.593), respectively. No disparities in other modifiable risk factors emerged at 1 year. CONCLUSIONS: Significant differences in important risk factors (physical activity and diastolic blood pressure) at baseline between Black and non-Black patients resolved at 1 year, suggesting that aggressive medical management may have an important role in ameliorating disparities in risk factor control between Black and non-Black patients.

Evaluation of a Carepartner-Integrated Telehealth Gait Rehabilitation Program for Persons with Stroke : Study Protocol for a Feasibility Study.

Background: Despite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this preliminary clinical trial is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility. Methods: This two-phased study will determine the feasibility of CARE-CITE-Gait, a novel intervention developed by our team that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-hour (home-based) visits for dyad collaborative goal setting. In Phase I, the usability and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In Phase II, feasibility (based on measures of recruitment, retention, and intervention adherence) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, evaluator blinded, quasi-experimental design with repeated measures (two baseline visits one week apart, post-test, and one-month follow-up) with 15 carepartner and stroke survivor dyads. Outcomes include psychosocial variables (strain, family conflict surrounding stroke recovery, autonomy support and life changes) collected from carepartners, and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors. Discussion: The findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process. Trial Registration: ClinicalTrials.gov, NCT05257928. Registered 25 February 2022, https://clinicaltrials.gov/ct2/show/NCT05257928.

Association of Sickle Cell Disease With Severe Maternal Morbidity.

OBJECTIVE: To evaluate the association between sickle cell disease (SCD) and severe maternal morbidity (SMM) in a contemporary cohort of deliveries by non-Hispanic Black people. METHODS: We retrospectively examined SMM by using electronic health record data on deliveries by non-Hispanic Black patients between 2011 and 2020 at a single tertiary, public institution. Sickle cell disease was identified during the delivery admission by using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. The primary outcome, SMM at delivery hospitalization, was ascertained using ICD-9-CM and ICD-10-CM codes and excluded sickle cell crisis as an indicator of SMM. We also constructed a secondary measure of SMM that excluded deliveries in which blood transfusion was the only indication of SMM. Poisson regression models were used to estimate risk ratios (RRs) and 95% CIs for the associations between SCD and SMM (overall and for individual indicators). Multivariable models adjusted for age, parity, insurance type, chronic conditions (chronic hypertension, diabetes mellitus, obesity), and multiple gestation. RESULTS: Among 17,493 deliveries by non-Hispanic Black patients during the study period, 132 (0.8%) had a diagnosis of SCD. Of those patients, 87 (65.9%, 95% CI 57.2-73.9) with SCD and 2,035 (11.7%), 95% CI 11.2-12.2) without SCD had SMM. Sickle cell disease was associated with increased risk of SMM (87 vs 2,035, adjusted risk ratio [aRR] 5.4, 95% CI 4.6-6.3) and nontransfusion SMM (51 vs 1,057, aRR 6.0, 95% CI 4.6-8.0). Effect estimates were highest for cardiac arrest (3 vs 14, RR 28.2, 95% CI 3.8-209.3), air and thrombotic embolism (14 vs 72, RR 25.6, 95% CI 12.0-54.6), and puerperal cerebrovascular disorders (10 vs 53, RR 24.8, 95% CI 10.2-60.5). CONCLUSION: Sickle cell disease was associated with a more than fivefold increased risk of SMM during the delivery hospitalization. Our data suggest cardiovascular morbidity as the driving major risk. The identification and monitoring of cardiovascular pathology in patients with SCD before and during pregnancy may reduce SMM.

Long-term strabismus outcomes after unilateral infantile cataract surgery in the Infant Aphakia Treatment Study.

PURPOSE: To characterize long-term strabismus outcomes in children in the Infant Aphakia Treatment Study (IATS). METHODS: This study was a secondary data analysis of long-term ocular alignment characteristics of children aged 10.5 years who had previously been enrolled in a randomized clinical trial evaluating aphakic management after unilateral cataract surgery between 1 and 6 months of age. RESULTS: In the IATS study, 96 of 109 children (88%) developed strabismus through age 10.5 years. Half of the 20 children who were orthophoric at distance through age 5 years maintained orthophoria at distance fixation at 10.5 years. Esotropia was the most common type of strabismus prior to age 5 years (56/109 [51%]), whereas exotropia (49/109 [45%]) was the most common type of strabismus at 10.5 years (esotropia, 21%; isolated hypertropia, 17%). Strabismus surgery had been performed on 52 children (48%), with 18 of these (35%) achieving microtropia <10Δ. Strabismus was equally prevalent in children randomized to contact lens care compared with those randomized to primary intraocular lens implantation (45/54 [83%] vs 45/55 [82%]; P = 0.8). Median visual acuity in the study eye was 0.56 logMAR (20/72) for children with orthotropia or microtropia <10Δ versus 1.30 logMAR (20/400) for strabismus ≥10Δ (P = 0.0003). CONCLUSIONS: Strabismus-in particular, exotropia-is common irrespective of aphakia management 10 years following infant monocular cataract surgery. The delayed emergence of exotropia with longer follow-up indicates a need for caution in managing early esotropia in these children. Children with better visual acuity at 10 years of age are more likely to have better ocular alignment.

Lipid Levels and Short-Term Risk of Recurrent Brain Infarcts in Symptomatic Intracranial Stenosis.

OBJECTIVES: Hyperlipidemia is a strong risk factor for intracranial atherosclerotic disease (ICAD) and clinical stroke recurrence. We explored the effect of serum lipid levels on subclinical infarct recurrence in the Mechanisms of earlY Recurrence in Intracranial Atherosclerotic Disease (MYRIAD) study. MATERIALS AND METHODS: We included enrolled MYRIAD patients with lipid measurements and brain MRI at baseline and brain MRI at 6-8 weeks. Infarct recurrence was defined as new infarcts in the territory of the symptomatic artery on brain MRI at 6-8 weeks compared to baseline brain MRI. We assessed the association between baseline total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels and recurrent infarct at 6-8 weeks using multivariable logistic regression. RESULTS: Among 74 patients (mean age 64.2±12.9 years, 59.5% were white, 60.8% men), 20 (27.0%) had new or recurrent infarcts. Mean HDL-C (37.2 vs. 43.9 mg/dL, P=0.037) was lower and TG (113.5 vs. 91.3 mg/dL, P=0.008) was higher while TC (199.8 vs. 174.3 mg/dL, P=0.061) and LDL-C (124.3 vs. 101.2 mg/dL, P=0.053) were nominally higher among those with recurrent infarcts than those without. LDL-C (adj. OR 1.022, 95% CI 1.004-1.040, P=0.015) and TG (adj. OR 1.009, 95% CI 1.001-1.016, P=0.021) were predictors of recurrent infarct at 6-8 weeks adjusting for other clinical and imaging factors. CONCLUSIONS: Baseline cholesterol markers can predict early infarct recurrence in patients with symptomatic ICAD. More intensive and rapid lipid lowering drugs may be required to reduce risk of early recurrence.

Risk Factors Control and Early Recurrent Cerebral Infarction in Patients with Symptomatic Intracranial Atherosclerotic Disease.

BACKGROUND: The risk of early recurrent cerebral infarction (RCI) is high in patients with symptomatic intracranial atherosclerotic disease (IAD). We sought to determine the relationship between risk factor control and early RCI risk among patients with symptomatic IAD. METHODS: We analyzed participants with symptomatic IAD in the multi-center prospective observational MYRIAD study. Risk factor control was assessed at 6-8-week follow-up. Optimal risk factor control was defined by target systolic blood pressure, being non-smoker, target physical activity, and antiplatelet and antilipidemic therapy compliance. Age-adjusted associations were calculated between risk factor control and RCI determined by MRI-evident new infarcts in the territory of the stenotic vessel at 6-8 weeks from the index event. RESULTS: Among 82 participants with clinical and brain MRI information available 6-8 weeks after the index event (mean age 63.5 ±12.5 years, 62.2% men), RCI occurred in 21 (25.6%) cases. At 6-8-week follow-up, 37.8% had target systolic blood pressure, 92.7% were non-smokers, 51.2% had target physical activity, and 98.8% and 86.6% were compliant with antiplatelet and antilipidemic therapy, respectively. Optimal risk factor control increased from 4.9% at baseline to 19.5% at 6-8-week follow-up (p=0.01). None of the participants with optimal risk factor control at follow-up had RCI (0% vs. 31.8%, p<0.01). CONCLUSIONS: Only one-fifth of MYRIAD participants had optimal risk factor control during early follow-up. Approximately half and two-thirds had physical inactivity and uncontrolled systolic blood pressure, respectively. These risk factors may represent important therapeutic targets to prevent early RCI in patients with symptomatic IAD.

Intracranial dolichoectasia in patients with symptomatic intracranial atherosclerotic disease: Results from the MYRIAD study.

BACKGROUND AND PURPOSE: It is unknown whether intracranial atherosclerotic disease (ICAD), in addition to causing stenosis, also associates with abnormal arterial enlargement, a condition known as intracranial dolichoectasia (IDE). Across symptomatic ICAD patients, we aim to determine IDE prevalence and IDE impact on cerebral hemodynamics and recurrent cerebral ischemia. METHODS: We analyzed 98 participants (mean age 63.8 ± 11.9 years, 56.1% men) of the prospective observational study MYRIAD. Participants were enrolled within 21 days of an ischemic stroke or transient ischemic attack caused by moderate-to-severe ICAD. Semi-automatic vessel segmentation was used to determine diameters, length, and tortuosity-index of proximal intracranial arteries. Either ectasia (increased diameter) or dolichosis (increased length or TI) defined IDE. We assessed IDE association with new infarcts during 12-month follow-up, and IDE correlation with cerebral hemodynamics determined by quantitative MR-angiography (QMRA), MR-perfusion weighted-imaging, and transcranial Doppler breath-holding index. RESULTS: IDE was present in 35.7% of patients and 10.2% of symptomatic arteries. Basilar stenosis was associated with higher IDE prevalence (27.8% vs. 8.8%, p = 0.04), whereas other symptomatic arteries showed no association with IDE. Symptomatic arteries with IDE had lower hypoperfusion prevalence on MR-PWI (11.1% vs. 28.4%, p = 0.03). Increased diameter (r = 0.33, p<0.01) and tortuosity-index (r = 0.29, p = 0.01) showed positive correlation with QMRA flow rate. IDE was not associated with new infarcts during follow-up. CONCLUSIONS: IDE was common among symptomatic ICAD patients. IDE was not associated with stroke recurrence. Instead, increased diameter and tortuosity correlated with improved blood flow across the stenotic artery, suggesting that IDE may originate as an adaptive mechanism in ICAD.

Predictors of Early Infarct Recurrence in Patients With Symptomatic Intracranial Atherosclerotic Disease.

BACKGROUND AND PURPOSE: While prior studies identified risk factors for recurrent stroke in patients with symptomatic intracranial atherosclerotic disease, few have assessed risk factors for early infarct recurrence. METHODS: We performed a post hoc analysis of the MYRIAD study (Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease) of intracranial atherosclerotic disease patients with recent (<21 days) stroke/transient ischemic attack, 50% to 99% stenosis and who underwent 6- to 8-week magnetic resonance imaging (MRI) per protocol. Infarct recurrence was defined as new infarcts in the territory of the symptomatic artery on brain MRI at 6 to 8 weeks compared to index brain MRI. Qualifying events and clinical and imaging outcomes were centrally ascertained by 2 independent reviewers. We assessed the association between baseline clinical and imaging variables and recurrent infarct in bivariate models and multivariable logistic regression to identify independent predictors of infarct recurrence. RESULTS: Of 105 enrolled patients in MYRIAD, 89 (84.8%) were included in this analysis (mean age, 64±12 years, 54 [60.7%] were male, and 53 [59.6%] were White). The median time from qualifying event to MRI was 51+16 days, on which 22 (24.7%) patients had new or recurrent infarcts. Younger age (57.7 versus 66.0 years; P<0.01), diabetes (32.6% versus 14.6%, P=0.05), index stroke (31.3% versus 4.6%, P=0.01), anterior circulation location of stenosis (29.7% versus 12.0%, P=0.08), number of diffusion-weighted imaging lesions (>1: 40.0%, 1: 26.9% versus 0: 4.4%, P<0.01), and borderzone infarct pattern (63.6% versus 25.0%, P=0.01) on baseline MRI were associated with new or recurrent infarcts. Age (adjusted odds ratio, 0.93 [95% CI, 0.89-0.98], P<0.01) and number of diffusion-weighted imaging lesions (adjusted odds ratio, 3.24 [95% CI, 1.36-7.71], P<0.01) were independently associated with recurrent infarct adjusting for hypertension, diabetes, and stenosis location (anterior versus posterior circulation). CONCLUSIONS: An index multi-infarct pattern is associated with early recurrent infarcts, a finding that might be explained by plaque instability and artery-to-artery embolism. Further investigation of plaque vulnerability in intracranial atherosclerotic disease is needed. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02121028.

Continuous EEG Findings in Autoimmune Encephalitis.

PURPOSE: Autoimmune encephalitis (AE) is a cause of new-onset seizures, including new-onset refractory status epilepticus, yet there have been few studies assessing the EEG signature of AE. METHODS: Multicenter retrospective review of patients diagnosed with AE who underwent continuous EEG monitoring. RESULTS: We identified 64 patients (male, 39%; white, 49%; median age, 44 years); of whom, 43 (67%) were antibody-proven AE patients. Of the patients with confirmed antibody AE, the following were identified: N-methyl-D-aspartate receptor (n = 17, 27%), voltage-gated potassium channel (n = 16, 25%), glutamic acid decarboxylase (n = 6, 9%), and other (n = 4, 6%). The remaining patients were classified as probable antibody-negative AE (n = 11, 17%), definite limbic encephalitis (antibody-negative) (n = 2, 3%), and Hashimoto encephalopathy (n = 8, 13%). Fifty-three percent exhibited electrographic seizures. New-onset refractory status epilepticus was identified in 19% of patients. Sixty-three percent had periodic or rhythmic patterns; of which, 38% had plus modifiers. Generalized rhythmic delta activity was identified in 33% of patients. Generalized rhythmic delta activity and generalized rhythmic delta activity plus fast activity were more common in anti-N-methyl-D-aspartate AE (P = 0.0001 and 0.0003, respectively). No other periodic or rhythmic patterns exhibited AE subtype association. Forty-two percent had good outcome on discharge. Periodic or rhythmic patterns, seizures, and new-onset refractory status epilepticus conferred an increased risk of poor outcome (OR, 6.4; P = 0.0012; OR, 3; P = 0.0372; OR, 12.3; P = 0.02, respectively). CONCLUSION: Our study confirms a signature EEG pattern in anti-N-methyl-D-aspartate AE, termed extreme delta brush, identified as generalized rhythmic delta activity plus fast activity in our study. We found no other pattern association with other AE subtypes. We also found a high incidence of seizures among patients with AE. Finally, periodic or rhythmic patterns, seizures, and new-onset refractory status epilepticus conferred an increased risk of poor outcome regardless of AE subtype.

The Myopic Shift in Aphakic Eyes in the Infant Aphakia Treatment Study After 10 Years of Follow-up.

OBJECTIVES: To report the myopic shift in the aphakic eyes of a cohort of children who underwent unilateral cataract surgery during infancy and were then followed longitudinally for 10.5 years. METHODS: One-half of the children enrolled in the Infant Aphakia Treatment Study (IATS) were randomized to aphakia and contact lens correction after unilateral cataract surgery. They then underwent ocular examinations using standardized protocols at prescribed time intervals until age 10.5 years. RESULTS: Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months. The median refractive error (RE) in the 57 eyes randomized to aphakia immediately after cataract surgery was 19.01 D (IQR: 16.98-20.49) compared to 10.38 D (IQR: 7.50-14.00) for the 30 eyes that remained aphakic at age 10.5 years. The mean change in RE in aphakic eyes was -2.11 D/year up to age 1.5 years, -0.68 D/year from 1.5 to 5.0 years, and -0.35 D/year from age 5 to 10.5 years. At age 10.5 years, 18 patients continued to wear a contact lens correction (silicone elastomer, n=6; gas permeable, n=6; hydrogel, n=5; and silicone hydrogel, n=1) (median RE, 12.50 D), 9 wore only spectacles (median RE, 4.00 D), and 4 wore no correction (median RE, 11.25 D) to correct their aphakic eye. CONCLUSIONS: The RE in aphakic eyes decreased by 44% from infancy to age 10.5 years. About two-thirds of children who remained aphakic at age 10.5 years continued to wear a contact lens.

Randomized Controlled Trial of a Novel Communication Device Assessed During Noninvasive Ventilation Therapy.

BACKGROUND: Noninvasive ventilation (NIV), a form of positive airway pressure (PAP) therapy, is the standard of care for various forms of acute respiratory failure (ARF). Communication impairment is a side effect of NIV, impedes patient care, contributes to distress and intolerance, and potentially increases intubation rates. This study aimed to evaluate communication impairment during CPAP therapy and demonstrate communication device improvement with a standardized protocol. RESEARCH QUESTION: How does an oronasal mask affect communication intelligibility? How does use of an NIV communication device change this communication intelligibility? STUDY DESIGN AND METHODS: A single-center randomized controlled trial (36 outpatients with OSA on CPAP therapy) assessed exposure to CPAP 10 cm H2O and PAP communication devices (SPEAX, Ataia Medical). Communication impairment was evaluated by reading selected words and sentences for partners to record and were tabulated as %words correct. Each outpatient-partner pair performed three assessments: (1) baseline (conversing normally), (2) mask baseline (conversing with PAP), and (3) randomized to functioning device (conversing with PAP and device) or sham device. After each stage, both outpatients and partners completed Likert surveys regarding perceived intelligibility and comfort. RESULTS: While conversing with PAP, word and sentence intelligibility decreased relatively by 52% (87% vs 41%) and relatively by 57% (94% vs 40%), respectively, compared with normal conversation. Word and sentence intelligibility in the intervention arm increased relatively by 75% (35% vs 61%; P < .001) and by 126% (33% vs 76%; P < .001) higher than the control arm, respectively. The device improved outpatient-perceived PAP comfort relatively by 233% (15% vs 50%, P = .042) and partner-perceived comfort by relatively 245% (20% vs 69%, P = .0074). INTERPRETATION: Use of this PAP communication device significantly improves both intelligibility and comfort. This is one of the first studies quantifying communication impairment during PAP delivery. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03795753; URL: www.clinicaltrials.gov.

Infarct Recurrence in Intracranial Atherosclerosis: Results from the MyRIAD Study.

BACKGROUND: Intracranial atherosclerotic disease (ICAD) is a common cause of ischemic stroke with a high risk of clinical stroke recurrence. Multiple mechanisms may underlie cerebral ischemia in this condition. The study's objective is to discern the mechanisms of recurrent ischemia in ICAD through imaging biomarkers of impaired antegrade flow, poor distal perfusion, abnormal vasoreactivity, and artery-to-artery embolism. METHODS: This prospective multicenter observational study enrolled patients with recent (≤21 days) ischemic stroke or transient ischemic attack (TIA) caused by ICAD with 50-99% stenosis treated medically. We obtained baseline quantitative MRA (QMRA), perfusion MRI (PWI), transcranial Doppler vasoreactivity (VMR), and emboli detection studies (EDS). The primary outcome was ischemic stroke in the territory of the stenotic artery within 1 year of follow-up; secondary outcomes were TIA at 1 year and new infarcts in the territory on MRI at 6-8 weeks. RESULTS: Amongst 102 of 105 participants with clinical follow-up (mean 253±131 days), the primary outcome occurred in 8.8% (12.7/100 patient-years), while 5.9% (8.5/100 patient-years) had a TIA. A new infarct in the territory of the symptomatic artery was noted in 24.7% at 6-8 weeks. A low flow state on QMRA was noted in 25.5%, poor distal perfusion on PWI in 43.5%, impaired vasoreactivity on VMR in 67.5%, and microemboli on EDS in 39.0%. No significant association was identified between these imaging biomarkers and primary or secondary outcomes. CONCLUSIONS: Despite intensive medical management in ICAD, there is a high risk of clinical cerebrovascular events at 1 year and an even higher risk of new imaging-evident infarcts in the subacute period after index stroke. Hemodynamic and plaque instability biomarkers did not identify a higher risk group. Further work is needed to identify mechanisms of ischemic stroke and infarct recurrence and their consequence on long-term physical and cognitive outcomes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02121028.

Refractive growth variability in the Infant Aphakia Treatment Study.

PURPOSE: Prediction of refraction after cataract surgery in children is limited by the variance in rate of refractive growth (RRG3). This study compared RRG3 in aphakic and pseudophakic eyes with their fellow, normal eyes in the Infant Aphakia Treatment Study. SETTING: Twelve clinical sites in the United States. DESIGN: Randomized clinical trial. METHODS: Infants randomized to unilateral cataract extraction had RRG3 calculated based on biometric data (axial length and keratometry) at cataract surgery and at 10 years of age, for both the normal and cataract eyes. Subjects were included if complete biometric data from both eyes were available both at surgery and at 10 years. Variance in RRG3 was compared between the groups with Pitman test for equality of variance between correlated samples. RESULTS: Longitudinal biometric data were available for 103 of the 114 patients enrolled. RRG3 was -15.00 diopters (D) (3.00 D) for normal eyes (reported as mean [SD]), -17.70 D (6.20 D) for aphakic eyes, and -16.70 D (6.20 D) for pseudophakic eyes (P < .0001 for comparison of variances in RRG3 between normal and all operated eyes). Further analysis found differences in the variance in axial length growth (P < .0001) between operated and normal eyes; the variance in keratometry measurement change did not reach significance. CONCLUSIONS: The standard deviation in the RRG3 of normal eyes in our study was half of that found in eyes that underwent cataract surgery.

Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.

BACKGROUND: The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage. METHODS: This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests. RESULTS: The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant. CONCLUSION: This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.

Globe Axial Length Growth at Age 10.5 Years in the Infant Aphakia Treatment Study.

PURPOSE: To report the change in globe axial length (AL) from the time of unilateral cataract surgery at age 1-7 months to age 10.5 years for infants enrolled in the Infant Aphakia Treatment Study, and to compare AL growth of operated eyes with that of fellow unoperated eyes. DESIGN: Comparative case series. METHODS: AL growth was analyzed relative to treated vs fellow eye, contact lens (CL) vs intraocular lens (IOL), visual acuity (VA) outcome, and the need for surgery for visual axis opacification. Eyes with glaucoma or glaucoma suspect were excluded from the primary analysis but reported separately. RESULTS: Fifty-seven patients have reliable AL data available at both visits. AL was shorter in treated eyes preoperatively (P < .0001) and at 10.5 years of age (P = .021) but AL growth was not different (4.7 mm, P = .99). The growth (70.2% up to age 5 and 29.8% from age 5 to 10.5) was similar in the CL and the IOL group (P = .79). Eyes grew 4.4 mm when visual acuity (VA) was better than 20/200, and 5.2 mm when VA was 20/200 or worse (P = .076). Eyes receiving additional surgery grew more than eyes not receiving additional surgery (P = .052). Patients with glaucoma showed significantly more eye growth (7.3 mm) than those without glaucoma (4.7 mm) and glaucoma suspects (5.1 mm) (P < .05). CONCLUSIONS: Eyes with glaucoma or poor VA often grew longer than the fellow eye. Overall, treated eyes grew similarly in the IOL and CL groups and also kept pace with the growth of the fellow eyes.

Factors associated with depressive symptoms of carepartners of stroke survivors after discharge from rehabilitation therapy.

Background: The long-term consequences of stroke affect both the carepartner (CP) and stroke survivor (SS). Understanding the effects of informal caregiving that may influence the ability of the family to carry over therapeutic activities in the home environment is critical for family-centered care.Objective: This study examined the relationship of CP and SS factors associated with CP depressive symptoms to gain insights into CP needs that may occur after formal rehabilitation therapy has ended for SS with upper extremity deficits.Methods: This correlational study used baseline data of 32 dyads of family CP and SS with upper extremity impairment who had completed rehabilitation therapy and were enrolled in a pilot study of a web-based CP-integrated rehabilitation program. Data using standard questionnaires for CP factors and SS memory and behavior problems and an objective assessment of SS upper extremity function were obtained. Data analysis included descriptive statistics and Pearson product moment correlations.Results: CPs were female (62.5%), White (61.29%), and spouses (68.75%). CPs reported mild-moderate depressive symptoms (M = 9.5 ± 8.3), and a majority had some degree of family conflict. Higher CP depressive symptoms were related to worse life changes (r = -0.41, p =.02), greater fatigue (r = 0.50, p =.004), less effective family functioning (r = 0.46, p =.01), less autonomy support to SS (r = -0.42, p =.02), and more SS memory and behavior problems (r = 0.45, p =.01). Only CP fatigue was related to SS upper extremity function.Conclusions: Negative impacts of caregiving were found in this group of relatively high physically functioning SS which may hinder CP from providing optimal support for SS. Addressing CP needs including education regarding depression, fatigue, SS memory, and behavior problems, and family functioning while SS is receiving rehabilitation therapy may be important considerations to help facilitate the CP to support the SS in carrying over therapeutic activities in the home environment.

Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial.

Importance: Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy. Objective: To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy. Design, Setting, and Participants: This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019. Interventions: Intraocular lens implantation at the time of cataract surgery. Main Outcomes and Measures: Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis. Results: Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was -0.54 to 0.47). Conclusions and Relevance: As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT00212134.