Racial, Ethnic, and Gender Diversity in United States Ophthalmology Clinical Trials.

Purpose: To investigate the representation of various gender, racial, and ethnic groups in ophthalmology clinical trials conducted in the United States (US) between 1997 and 2022. Design: Retrospective cross-sectional study. Participants: We included all participants in completed phase II/III, III, and IV ophthalmology clinical trials reported on the ClincialTrials.gov database. Methods: The proportional enrollment of each racial/ethnic and gender group in the clinical trials was calculated and compared with the US population. We also investigated the impact of various clinical trial features on the rate of reporting demographic information and enrollment of minorities. Main Outcome Measures: Proportional enrollment of each gender and race/ethnicity group compared with the US Census. Results: Of the total clinical trials included in the study, less than half (43.6%) provided information on the racial or ethnic backgrounds of their participants. The majority of the enrollees in trials were female (median: 57.5%, interquartile range [IQR]: 47.2%-65.8%). Among the trials that reported race and/or ethnicity data, White populations were overrepresented (median: 76.6%, IQR: 69.0%-84.0%, P = 0.001), and minorities, including Asian, Hispanic, and "other" groups, were underrepresented compared with the 2010 US Census (P < 0.001). Enrollment of Black individuals was found to be comparable to the US population estimates (median: 12.4%, IQR: 6.2%-20.8%, P = 0.44). The trial phase, the number of study participants, the primary clinical condition, and the year the trial started all affected demographic reporting and minority enrollments. Conclusions: Our findings highlight the need for increased efforts to promote diversity and inclusivity in ophthalmology clinical trials. Ensuring equitable inclusion of different gender, racial, and ethnic groups in the trials is essential for minimizing disparities and producing unbiased scientific findings generalizable to the entire population. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Daily Oxygen Supplementation and Risk of Retinopathy of Prematurity.

PURPOSE: Excessive oxygen supplementation increases risk of retinopathy of prematurity (ROP). While numerous oxygen parameters could be considered when predicting ROP (saturation targets, actual saturation, fraction of inspired oxygen, etc.), complicated measures are impractical as screening criteria. We sought to develop a simple, clinically useful measure of daily oxygen supplementation during ages 0-28 days to improve prediction of ROP. METHODS: Secondary analysis of two Postnatal Growth and ROP (G-ROP) Study cohorts (G-ROP-1 and G-ROP-2) at 45 hospitals. Infants with a known ROP outcome and complete oxygen data were included. Associations between severe ROP and days on supplemental oxygen (FiO2 > 21%), during ages 0-28 days (DSO28) were assessed, controlling for birth weight (BW) and gestational age (GA). New screening criteria incorporating DSO were developed and compared to current guidelines. RESULTS: Among 8,949 studied infants, 459 (5.1%) developed type 1 ROP. DSO28 was associated with severe ROP (adjusted-OR 1.05 per day supplemental oxygen, 95%CI 1.03-1.07, p < .0001). The following criteria had 100% sensitivity for type 1 ROP and higher specificity than current guidelines: new BW/GA criteria with DSO (BW<901 g, GA<26 weeks, or DSO >3), 23.4% fewer infants examined; modified G-ROP criteria including DSO, 29.0% fewer infants; original G-ROP criteria, 31.8% fewer infants. CONCLUSION: In high-level neonatal-care settings, incorporating DSO (a simple measure of oxygen supplementation) into screening criteria improves sensitivity and specificity for type 1 ROP over current BW-GA criteria, but does not perform as well as the validated G-ROP criteria.

Biphasic synovial sarcoma of the hypopharynx: Case report and literature review.

INTRODUCTION: Synovial Sarcoma is a rare malignancy that accounts between 8 and 10% of soft tissue neoplasms, with the highest presentation rate in extremities, an extremely uncommon condition in head and neck. CLINICAL FINDINGS: We present a case of an 18-year-old male with synovial sarcoma situated at hypopharynx who underwent surgical resection and postoperative radiotherapy. CONCLUSION: Synovial Sarcoma represents a rare head and neck malignancy with challenging diagnostic approach due to its frequency and nonspecific clinical manifestations. Surgical treatment must assure good free margins. Adjuvant radiotherapy has a positive impact in local recurrence and survival.

Parental Feeding Styles and Their Association With Complementary Feeding Practices and Growth in Mexican Children.

Background: Complementary feeding practices and corresponding parental feeding styles influence nutritional status in later stages of childhood. Findings on the association of these variables with infant growth remain inconsistent; in Mexico, a research gap exists in this area. Research Aims: (1) To characterize parental feeding styles and complementary feeding practices, and (2) to evaluate the association of parental feeding styles with complementary feeding practices and infant growth at 6 and 9 months of age. Methods: Data were collected from a prospective Mexican birth cohort. Parental feeding styles, complementary feeding practices, and anthropometric data from 263 to 234 mother-child pairs (infants of 6 and 9 months of age, respectively) were analyzed. Logistic and linear regression models were used to determine the associations between variables. Results: The predominant parental feeding style was the "responsive style" (90%). Only 43.7 and 8.1% of 6- and 9-month-old infants, had adequate complementary feeding practices, respectively. At 6 months, mothers who were responsive to satiety signals had 11% lesser possibilities (OR = 0.89, 95% CI [0.80, 0.98]) of their infant having inadequate complementary feeding practices than their counterparts and "pressuring to finish" and "pressuring to eat cereal" sub-constructs were associated with lower weight for length and body mass index Z-scores (p = 0.02). Conclusions: A high proportion of infants (>40%) did not meet international recommendations. The "pressuring" parental feeding style sub-constructs were associated with growth indicators in 6-month old infants. This emphasizes the importance of promoting parental responsiveness to infant appetite and satiety signals to achieving adequate complementary feeding practices.

Vitreous Findings by Handheld Spectral-Domain OCT Correlate with Retinopathy of Prematurity Severity.

PURPOSE: To evaluate the association between retinopathy of prematurity (ROP) and vitreous findings in premature infants detected by handheld spectral-domain (SD) OCT. DESIGN: Prospective, observational cohort study. PARTICIPANTS: Consecutive sample of 92 premature infants requiring ROP screening at 2 academic neonatal intensive care units between July 2015 and March 2018. METHODS: Infants underwent handheld SD OCT at the time of routine ROP examinations. Two masked, trained graders analyzed right-eye vitreoretinal findings, including semiautomated quantification of punctate hyperreflective vitreous opacities within 5 foveal or parafoveal B-scans (vitreous opacity ratio). MAIN OUTCOME MEASURES: Excluding posttreatment data, vitreous findings were compared with clinical ROP diagnoses. RESULTS: Agreement between image graders for all vitreoretinal findings was 91% (κ = 0.86; 95% confidence interval, 0.82-0.90; P < 0.001). Among 92 infants undergoing 280 imaging sessions (52% male; mean gestational age, 28.3 ± 2.8 weeks; mean birthweight, 1014.5 ± 285.0 g), 36 of 92 (39%) demonstrated ROP. Punctate hyperreflective vitreous opacities were identified in 61 of 92 infants (66%). The presence of punctate hyperreflective vitreous opacities at least once was associated with a diagnosis of ROP (62% vs. 29% without opacities; P = 0.003), maximum ROP stage (P = 0.001), preplus or plus disease (24% vs. 5%; P = 0.005), and type 1 disease (14% vs. 2%; P = 0.03). Among 29 infants (45 imaging sessions) with right-eye punctate hyperreflective vitreous opacities, the vitreous opacity ratio from 2 graders (F1 score, 0.82 ± 0.36; Dice coefficient, 0.97 ± 0.04) correlated with ROP stage (P = 0.02). Tractional vitreous bands on imaging correlated with plus disease status (29% vs. 5% without bands; P = 0.05). CONCLUSIONS: Punctate hyperreflective vitreous opacities and tractional vitreous bands predict the presence and severity of ROP. Further studies should explore handheld OCT as a noninvasive ROP screening tool.

Visual Function, Brain Imaging, and Physiological Factors in Children With Asymmetric Nystagmus due to Chiasmal Gliomas.

PURPOSE: Asymmetric nystagmus can be an important presenting sign of optic pathway gliomas in young children. We investigated the causes of asymmetric nystagmus in children with chiasmal or suprasellar optic pathway gliomas compared with children with similar optic pathway gliomas and stable gaze. METHODS: Longitudinal magnetic resonance imaging before and after treatment, age-corrected visual acuity, ocular examinations, video-oculography, visual evoked potentials, and retinal nerve fiber layer thickness were retrospectively reviewed. RESULTS: Twenty-two children were included (eight with asymmetric nystagmus and 14 with stable gaze). Subjects with asymmetric nystagmus presented at a younger age than those with stable gaze (2.0 vs 5.6 years; P < 0.001). None had neurofibromatosis type 1. Visual acuity, visual evoked potentials, nerve fiber layer, severity of optic atrophy, hydrocephalus, tumor volume, and tumor locations did not differ between those with asymmetric nystagmus and stable gaze. Asymmetric nystagmus resolved shortly after treatment, even though the average visual acuity did not improve. Changes in visual acuity or tumor volume were not different between those with asymmetric nystagmus and stable gaze after treatment. Eye movement recording from two subjects with asymmetric nystagmus revealed an asymmetric pendular-oscillation with vertical components. One subject with stable gaze developed asymmetric nystagmus with tumor growth into the rostral midbrain and associated unilateral vision loss. Another subject with tumor growth into the rostral midbrain acquired vertical saccade dysmetria. CONCLUSION: We hypothesize that asymmetric nystagmus associated with optic pathway gliomas is caused by subclinical abnormalities to retinal axons that connect to gaze holding centers in the rostral midbrain. Direct compression of the rostral midbrain was a possible factor to asymmetric nystagmus in some subjects. However, many subjects with stable gaze also show midbrain compression.

Scleral Contact Lenses in an Academic Oculoplastics Clinic: Epidemiology and Emerging Considerations.

PURPOSE: To describe the role and efficacy of scleral contact lenses (SCLs) in the treatment of progressive keratopathy in patients who have undergone periocular surgical procedures, to investigate the financial impact of these surgical interventions, and to demonstrate the role of oculoplastic surgery in improving scleral contact lens fit. METHODS: A retrospective medical record review was performed to identify patients who both received SCLs and were examined by the oculoplastics service at the University of Iowa between January 1990 and December 2015. Inclusion criteria also required a minimum of 12 months of patient follow up after being fit with a SCL. The indication for SCL use, as well as clinical outcomes and cumulative relative value units (RVUs) of prior oculoplastic treatments and SCL therapy were recorded for each patient. RESULTS: Six hundred and fifty-nine patients were fitted with SCLs at the authors' institution during the 25-year study period, 43 of whom were examined by the oculoplastics service for reasons related to their SCL. Patients who were fitted for SCLs before (27 patients) or after (16 patients) evaluation in the oculoplastics clinic presented with a variety of corneal and periocular pathology. Corneal indications for SCLs in patients seen secondarily in the oculoplastics clinic included decreased corneal sensation (from CN V palsy or neurotrophic keratopathy), decreased corneal healing from limbal stem cell deficiency, exposure keratopathy, and keratoconjunctivitis sicca secondary to Sjogren's syndrome or orbital radiation. Indications for oculoplastic clinic evaluation in current scleral lens patients included lagophthalmos, trichiasis, epiphora, cicatricial changes in the eyelids or fornices, and eyelid or eyebrow malposition affecting SCL centration. In all 27 patients, surgical intervention resulted in improved SCL centration. Sixteen patients (5 with CN VII palsy, 4 with CN V and CN VII palsy, 4 with neurotrophic keratitis, and 3 with cicatricial entropion) had progressive corneal decompensation despite primary oculoplastics procedures to protect the cornea and ultimately benefitted from SCL treatment secondarily. Fourteen of these 16 patients demonstrated an improved visual acuity of 1 line or more using SCLs. Procedures performed before referral for SCLs included tarsorrhaphies, gold weights, ectropion repair with lateral tarsal strip, retraction repair with spacer grafts, full-thickness skin grafts, cheek lifts, and punctal occlusion. The total RVUs of these procedures performed per patient were tabulated. The RVU range was 10.47-33.96 with an average of 19.5 RVUs (standard deviation = 9.4 RVUs) per patient. CONCLUSIONS: Scleral contact lenses may offer a useful alternative to stabilize the ocular surface, improve vision, and minimize the financial impact and morbidity of multiple periocular procedures in select patients with progressive keratopathy of varying etiologies. The therapeutic indications and utilization of SCLs are likely to increase in oculoplastic practices with optometric support, particularly in academic settings. Surgical correction of eyelid and eyebrow malposition, as well as epiphora, may also be useful adjunctive procedures to optimize SCL fit.

[Violence and mental health issues among Mexican adolescents that have considered or attempted cross-border migration]. / Violencia y salud mental asociados a pensar o haber intentado emigrar internacionalmente por adolescentes mexicanos.

The aim of this study was to estimate the role of victimization by violence among Mexican adolescents that have considered or attempted migrating to the United States, including mental health variables (emotional self-esteem, self-esteem in school, depression, suicidal ideation, and attempted suicide) as mediators of the effects. The study used a cross-sectional design with a stratified cluster sample of 13,198 adolescents from the 2nd Mexican National Survey on Exclusion, Intolerance, and Violence in public schools in 2009. The analysis used the regression models proposed by Baron & Kenny. Prevalence of having considered or attempted cross-border migration was 23.1%. Mean age was 16.36 years. Female adolescents constituted 54.9% of the sample, and 56% were lower-income. Mental health variables that acted as partial mediators were suicidal ideation (35.9%), depression (19.2%), attempted suicide (17.7%), emotional self-esteem (6.2%), and self-esteem in school (3.4%) for moderate family violence, and emotional self-esteem (17.5%) for social rejection in school and suicidal ideation (8.1%) for physical harm in school. Female adolescents showed greater impact from mediators than men in considering or having attempted cross-border migration. The study discusses the importance of incorporating the prevention of violence in the social contexts studied here and incorporating mental health in dealing with violence in adolescents and in public health programs in transit areas for illegal migrants.

Development and Validation of an Instrument to Evaluate Perceived Wellbeing Associated with the Ingestion of Water: The Water Ingestion-Related Wellbeing Instrument (WIRWI).

BACKGROUND: Ingestion of water has been associated with general wellbeing. When water intake is insufficient, symptoms such as thirst, fatigue and impaired memory result. Currently there are no instruments to assess water consumption associated with wellbeing. The objective of our study was to develop and validate such an instrument in urban, low socioeconomic, adult Mexican population. METHODS: To construct the Water Ingestion-Related Wellbeing Instrument (WIRWI), a qualitative study in which wellbeing related to everyday practices and experiences in water consumption were investigated. To validate the WIRWI a formal, five-process procedure was used. Face and content validation were addressed, consistency was assessed by exploratory and confirmatory psychometric factor analyses, repeatability, reproducibility and concurrent validity were assessed by conducting correlation tests with other measures of wellbeing such as a quality of life instrument, the SF-36, and objective parameters such as urine osmolality, 24-hour urine total volume and others. RESULTS: The final WIRWI is composed of 17 items assessing physical and mental dimensions. Items were selected based on their content and face validity. Exploratory and confirmatory factor analyses yielded Cronbach's alpha of 0.87 and 0.86, respectively. The final confirmatory factor analysis demonstrated that the model estimates were satisfactory for the constructs. Statistically significant correlations with the SF-36, total liquid consumption and simple water consumption were observed. CONCLUSION: The resulting WIRWI is a reliable tool for assessing wellbeing associated with consumption of plain water in Mexican adults and could be useful for similar groups.

Incidence of unplanned return to the operating room following vitreoretinal surgery at a public teaching hospital.

PURPOSE: To determine the incidence of unplanned return to the operating room within 30 or 90 d following vitreoretinal surgery. METHODS: Hospital records of 431 patients undergoing vitreoretinal surgery at San Francisco General Hospital between 1 January 1998 and 31 December 2009 were reviewed to determine the incidence of unplanned reoperations. RESULTS: Unplanned reoperation occurred within 30 d in 22 cases (3.77%) and within 90 d in 56 cases (9.61%). CONCLUSIONS: This study establishes benchmarks for the rate of unplanned return to the operating room following vitreoretinal surgery at an urban teaching hospital. Measuring reoperation within 90 d may provide a useful quality improvement metric of short- and middle-term complications.

[Gender role orientation and tobacco and alcohol use among youth in Morelos, Mexico]. / Orientación al rol de género y uso de tabaco y alcohol en jóvenes de Morelos, México.

OBJECTIVE: To quantify the association between gender role orientation and tobacco and alcohol use among young people of the State of Morelos. MATERIALS AND METHODS: Study conducted in 2004-2005, students aged 14 to 24 years (n = 1 730). Sociodemographic variables (area of residence, socioeconomic status), family (parental education and violence), psycho-sociological (gender role, self-esteem, depression, alcohol consumption, tobacco, locus of control, sexual abuse). Logistic regression analysis. RESULTS: Factors associated with use of tobacco: In women, being androgynous undesirable, masculine role, attempted sexual abuse and urban areas. For men, depression and submission. Factors associated with alcohol use: In women, masculine gender role; and in men to be older than 20 years, living in semi-urban and urban area, and internal locus. CONCLUSIONS: The machismo is one of the gender role orientations with greater association with the use of tobacco primarily in girls in Mexico, and the masculine or instrumental role with alcohol.

Orientación al rol de género y uso de tabaco y alcohol en jóvenes de Morelos, México / Gender role orientation and tobacco and alcohol use among youth in Morelos, Mexico

OBJETIVO: Cuantificar la asociación entre orientación al rol de género y uso de tabaco y alcohol en jóvenes del estado de Morelos. MATERIAL Y MÉTODOS: Estudio transversal realizado en 2004-2005, en jóvenes de 14 a 24 años (n=1 730). Variables sociodemográficas (zona de residencia, nivel socioeconómico); familiares (educación y violencia paternal); psicosociológicas (rol de género, autoestima, depresión, consumo de alcohol, tabaco, locus de control, abuso sexual). Análisis por regresión logística. RESULTADOS: Factores asociados con uso de tabaco: en mujeres, andrógina, no deseable, machista, intento de abuso sexual y zona urbana. Para hombres, depresión y sumisión. Factores asociados con uso de alcohol: en mujeres, rol masculino, y hombres, edad más de 20 años, vivir en zona semiurbana y urbana y locus interno. CONCLUSIONES: El machismo es una de las orientaciones al rol de género con mayor asociación con el uso de tabaco principalmente en las jóvenes, y la orientación masculina o instrumental se asocia con el alcohol.

OBJECTIVE: To quantify the association between gender role orientation and tobacco and alcohol use among young people of the State of Morelos. MATERIALS AND METHODS: Study conducted in 2004-2005, students aged 14 to 24 years (n = 1 730). Sociodemographic variables (area of residence, socioeconomic status), family (parental education and violence), psycho-sociological (gender role, self-esteem, depression, alcohol consumption, tobacco, locus of control, sexual abuse). Logistic regression analysis. RESULTS: Factors associated with use of tobacco: In women, being androgynous undesirable, masculine role, attempted sexual abuse and urban areas. For men, depression and submission. Factors associated with alcohol use: In women, masculine gender role; and in men to be older than 20 years, living in semi-urban and urban area, and internal locus. CONCLUSIONS: The machismo is one of the gender role orientations with greater association with the use of tobacco primarily in girls in Mexico, and the masculine or instrumental role with alcohol.