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PurposeTo construct a comprehensive reference database (RDB) for a novel binocular automated perimeter.DesignA four-site prospective randomized clinical trial.Subjects and controlsThree hundred fifty-six healthy subjects without ocular conditions that might affect visual function were categorized into 7 age groups.MethodsSubjects underwent comprehensive ocular examination of both eyes before enrollment. Using the TEMPO/IMOvifa automated perimeter (Topcon Healthcare/CREWT Medical Systems), each subject completed 4 binocular threshold visual field (VF) tests during a single visit: First, practice 24-2 and 10-2 tests were obtained from both eyes. Next, study 24-2 and 10-2 tests were obtained from both eyes. Test order of each sequence was randomized, and the tests were conducted under standard automated perimetry testing conditions: Goldmann stimulus size III, 3183 cd/m2 maximum stimulus intensity, and background intensity of 10 cd/m2, using AIZE-Rapid test strategy. Standard VF reliability indices were assessed. For each subject, 24-2 and 10-2 test results from 1 randomly selected eye were analyzed.Main outcome measuresPerimetric threshold sensitivity and reference limits for each test analysis parameter.ResultsThe ages of the study cohort were widely distributed, with a mean age (standard deviation [SD]) of 52.3 (18.5) years. Sex assignment was 44.0% male and 56.0% female. The majority of subjects self-identified as White (67.4%), followed by Black or African American (13.5%) and Asian (8.7%), with 14.6% self-identified as Hispanic or Latino ethnicity. Mean sensitivity (SD) was 29.1 (1.3) decibels (dB) for the 24-2 and 32.4 (1.0) dB for the 10-2 test. For the 24-2 and 10-2, mean sensitivity (SD) age-related changes averaged -0.06 (0.01) dB and -0.05 (0.01) dB per year, respectively. The normal range of pointwise threshold sensitivity increased with eccentricity and showed asymmetry around the mean, particularly notable in the 24-2 test. Mean (SD) binocular test duration was 3.18 (0.38) minutes (1 minute 35 seconds per eye) for the 24-2 test and 3.58 (0.43) minutes (1 minute 47 seconds per eye) for the 10-2 test.ConclusionsAn RDB for the TEMPO/IMOvifa perimeter was established, highlighting the significance of considering both age and stimulus eccentricity in interpreting threshold VF test results.Financial disclosuresProprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: To construct a comprehensive reference database (RDB) for a novel binocular automated perimeter. Design: A four-site prospective randomized clinical trial. Subjects and Controls: Three hundred fifty-six healthy subjects without ocular conditions that might affect visual function were categorized into 7 age groups. Methods: Subjects underwent comprehensive ocular examination of both eyes before enrollment. Using the TEMPO/IMOvifa automated perimeter (Topcon Healthcare/CREWT Medical Systems), each subject completed 4 binocular threshold visual field (VF) tests during a single visit: First, practice 24-2 and 10-2 tests were obtained from both eyes. Next, study 24-2 and 10-2 tests were obtained from both eyes. Test order of each sequence was randomized, and the tests were conducted under standard automated perimetry testing conditions: Goldmann stimulus size III, 3183 cd/m2 maximum stimulus intensity, and background intensity of 10 cd/m2, using AIZE-Rapid test strategy. Standard VF reliability indices were assessed. For each subject, 24-2 and 10-2 test results from 1 randomly selected eye were analyzed. Main Outcome Measures: Perimetric threshold sensitivity and reference limits for each test analysis parameter. Results: The ages of the study cohort were widely distributed, with a mean age (standard deviation [SD]) of 52.3 (18.5) years. Sex assignment was 44.0% male and 56.0% female. The majority of subjects self-identified as White (67.4%), followed by Black or African American (13.5%) and Asian (8.7%), with 14.6% self-identified as Hispanic or Latino ethnicity. Mean sensitivity (SD) was 29.1 (1.3) decibels (dB) for the 24-2 and 32.4 (1.0) dB for the 10-2 test. For the 24-2 and 10-2, mean sensitivity (SD) age-related changes averaged −0.06 (0.01) dB and −0.05 (0.01) dB per year, respectively. The normal range of pointwise threshold sensitivity increased with eccentricity and showed asymmetry around the mean, particularly notable in the 24-2 test. Mean (SD) binocular test duration was 3.18 (0.38) minutes (1 minute 35 seconds per eye) for the 24-2 test and 3.58 (0.43) minutes (1 minute 47 seconds per eye) for the 10-2 test. Conclusions: An RDB for the TEMPO/IMOvifa perimeter was established, highlighting the significance of considering both age and stimulus eccentricity in interpreting threshold VF test results. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Cytosine methylation contributes to the regulation of gene expression and normal hematopoiesis in mammals. It is catalyzed by the family of DNA methyltransferases that include DNMT1, DNMT3A, and DNMT3B. Peripheral T–cell lymphomas (PTCLs) represent aggressive mature T–cell malignancies exhibiting a broad spectrum of clinical features with poor prognosis and inadequately understood molecular pathobiology. To better understand the molecular landscape and identify candidate genes involved in disease maintenance, we profiled DNA methylation and gene expression of PTCLs. We found that the methylation patterns in PTCLs are deregulated and heterogeneous but share 767 hypo- and 567 hypermethylated differentially methylated regions (DMRs) along with 231 genes up- and 91 genes downregulated in all samples, suggesting a potential association with tumor development. We further identified 39 hypomethylated promoters associated with increased gene expression in the majority of PTCLs. This putative oncogenic signature included the TRIP13 (thyroid hormone receptor interactor 13) gene whose genetic and pharmacologic inactivation inhibited the proliferation of T–cell lines by inducing G2-M arrest and apoptosis. Our data thus show that human PTCLs have a significant number of recurrent methylation alterations that may affect the expression of genes critical for proliferation whose targeting might be beneficial in anti-lymphoma treatments.

Background: Adrenal Cushing syndrome (CS) is usually benign in etiology; however, although rarely, it can be due to adrenocortical carcinoma (ACC); in which case, diagnosis and management are quite complicated. Case Report: A 34-year-old woman presented with worsening confusion, weight gain, new-onset diabetes, and hypertension. Her history was significant for a 7.4-cm left adrenal mass and CS, which were treated with left adrenalectomy 2 years ago. She received hydrocortisone replacement therapy after the surgery, which was discontinued on admission when evaluation showed hypokalemia, hypercortisolemia, and undetectable adrenocorticotropic hormone. Subsequent testing included 1-mg and 8-mg dexamethasone suppression tests, which did not suppress cortisol; late-night salivary cortisol measurement, which yielded a very high salivary cortisol level; and 24-hour urinary cortisol measurement. The level of 11-deoxycortisol was elevated. A computed tomography scan revealed multiple hepatic lesions, which were fluorodeoxyglucose avid, and a biopsy confirmed metastatic ACC. She received treatment with mitotane, metyrapone (later changed to mifepristone), doxorubicin, cisplatin, and etoposide. Over 8 weeks, mitotane levels became therapeutic at 20 mcg/mL, the hepatic masses decreased in size, and she transitioned to adrenal insufficiency and improved glycemic control. Next-generation sequencing of liver biopsy and germline testing revealed a frameshift loss-of-function allelic variant in the FH gene that encodes the protein fumarate hydratase. Discussion: We report a case of recurrent CS due to metastatic ACC in a patient with a previously resected adrenal adenoma and FH allelic variant. Conclusion: Metastatic ACC presenting with severe CS presents a diagnostic and management challenge where combination therapy guided by a multidisciplinary team is essential. FH allelic variant may contribute to ACC progression.

Objectives: Body image adjustment is a crucial issue for patients with facial cancer, but body image–specific interventions are scarce. We report results of a novel psychotherapeutic intervention to address body image concerns during acute postoperative recovery following facial reconstructive surgery. Our primary aims were to evaluate the intervention's feasibility, acceptability, and efficacy on body image concerns, psychological distress, and quality of life (QOL). Methods: Adults with facial cancers who endorsed body image concerns were recruited to participate in a randomized controlled trial. The intervention group participated in 4 in-person counseling sessions. The control group received an educational booklet and a brief phone call. Participants completed measures of body image, distress, and QOL at baseline and at the 4-week follow-up to assess the impact of the intervention. Intervention outcomes were assessed with 2 sample t- tests or Mann–Whitney U tests as appropriate. Results: Twenty-nine participants completed both the baseline and follow-up assessments. The intervention demonstrated good feasibility with a high retention rate (79%), visit completion rate (81%), and high satisfaction scores (75% reported mean satisfaction score of >3). Intervention did not result in an observed statistically significant difference in reduction in body image dissatisfaction and disturbance, psychological distress, or improvement in QOL compared with the control group. However, intervention resulted in statistically significant difference in perceived social impact (−1 vs. −8.3, p  = 0.033) compared to control group. Significance of results: Our study highlights the potential clinical benefits of a novel psychotherapeutic intervention that targets body image concerns and suggests the need for further evaluation. [ABSTRACT FROM AUTHOR]

Cytosine methylation contributes to the regulation of gene expression and normal hematopoiesis in mammals. It is catalyzed by the family of DNA methyltransferases that include DNMT1, DNMT3A, and DNMT3B. Peripheral T–cell lymphomas (PTCLs) represent aggressive mature T–cell malignancies exhibiting a broad spectrum of clinical features with poor prognosis and inadequately understood molecular pathobiology. To better understand the molecular landscape and identify candidate genes involved in disease maintenance, we profiled DNA methylation and gene expression of PTCLs. We found that the methylation patterns in PTCLs are deregulated and heterogeneous but share 767 hypo- and 567 hypermethylated differentially methylated regions (DMRs) along with 231 genes up- and 91 genes downregulated in all samples, suggesting a potential association with tumor development. We further identified 39 hypomethylated promoters associated with increased gene expression in the majority of PTCLs. This putative oncogenic signature included the TRIP13 (thyroid hormone receptor interactor 13) gene whose genetic and pharmacologic inactivation inhibited the proliferation of T–cell lines by inducing G2-M arrest and apoptosis. Our data thus show that human PTCLs have a significant number of recurrent methylation alterations that may affect the expression of genes critical for proliferation whose targeting might be beneficial in anti-lymphoma treatments. [ABSTRACT FROM AUTHOR]

PurposeTo describe the process by which imaging devices undergo reference database development and regulatory clearance. The limitations and potential improvements of reference (normative) data sets for ophthalmic imaging devices will be discussed.MethodA symposium was held in July 2013 in which a series of speakers discussed issues related to the development of reference databases for imaging devices.ResultsAutomated imaging has become widely accepted and used in glaucoma management. The ability of such instruments to discriminate healthy from glaucomatous optic nerves, and to detect glaucomatous progression over time is limited by the quality of reference databases associated with the available commercial devices. In the absence of standardized rules governing the development of reference databases, each manufacturer's database differs in size, eligibility criteria, and ethnic make-up, among other key features.ConclusionsThe process for development of imaging reference databases may be improved by standardizing eligibility requirements and data collection protocols. Such standardization may also improve the degree to which results may be compared between commercial instruments.

Increasing attention is being given to developing quantitative measures of facial expression. This study used quantitative facial expression analysis to examine associations between smiling intensity and psychosocial functioning in patients with head and neck cancer (HNC). Smiling intensity of 95 HNC patients was measured using 48 quantitative measures calculated from facial photographs with and without a smile. We computed a composite smiling intensity score for each patient representing the degree of similarity to healthy controls. A lower composite score indicates that the person is less expressive, on average, than healthy controls. Patients also completed self-report measures assessing domains of body image and quality of life (QOL). Spearman rank correlations were computed to examine relationships between composite scores and psychosocial functioning. Composite scores were significantly correlated with multiple measures of body image and QOL. Specifically, decreased smiling intensity was associated with feelings of dissatisfaction with one's body, perceived negative social impact of body image, increased use of avoidance as a body image-coping strategy, reduced functional well-being, and greater head and neck cancer-specific issues. To the best of our knowledge, this is the first study to demonstrate associations between an objectively quantified facial expression (i.e. smiling) and psychosocial functioning. Most previous studies have measured facial expression qualitatively. These findings indicate that smiling intensity may serve as an important clinical indicator of psychosocial well-being and warrants further clinical investigation.

Michael Chaglasian,1 Murray Fingeret,2 Pinakin Gunvant Davey,3 Wei-Chieh Huang,4 Danny Leung,4 Edmund Ng,5 Charles A Reisman4 1Illinois Eye Institute, Illinois College of Optometry, Chicago, IL, USA; 2Department of Veterans Affairs, New York Harbor Health Care System, Brooklyn, NY, USA; 3School of Optometry, Western University of Health Sciences, Pomona, CA, USA; 4Topcon Healthcare Solutions Research and Development, Oakland, NJ, USA; 5Edmund Ng Consulting, LLC, Seattle, WA, USA Importance: The paper presents the range for measurements taken with a new spectral domain optical coherence tomography (OCT) device to establish a reference database for discrimination purposes. Objective: To report the range of thickness values for the new Topcon Maestro 3D OCT device with 2 scan size settings: the 12×9 mm wide field and 6×6 mm scans. Design: Prospective, multicenter cohort study conducted at 7 clinical sites across the USA. Setting: Primary eyecare clinics within academic, hospital, and private practice locations. Participants: Healthy volunteers; all enrolled participants underwent a complete ophthalmological examination to confirm healthy ocular status prior to being enrolled in the study. Main outcome measure: Average and 1st, 5th, 95th, and 99th percentile ranges for OCT parameters Early Treatment Diabetic Retinopathy Study macula full retinal thickness, ganglion cell + inner plexiform layer thickness (GCL + IPL), ganglion cell complex (GCC) thickness, circumpapillary retinal nerve fiber layer (cpRNFL) thickness. Results: Three hundred and ninety-nine eyes of 399 subjects were included in the analysis. Mean (SD) age was 46.3 (16.3) years (range 18–88 years). Forty-three percent of the subjects were male. Mean (SD) measurements (in μm) for the 12×9 mm wide scan were as follows: foveal thickness=237.079 (20.899), GCL + IPL=71.363 (5.924), GCC=105.949 (8.533), cpRNFL=104.720 (11.829); measurements for the 6×6 mm scans were as follows: foveal thickness=234.000 (20.657), GCL + IPL=71.726 (5.880), GCC=106.698 (9.094), cpRNFL=104.036 (11.341). Conclusion: The overall normal thickness values reported with Topcon 3D OCT-1 Maestro were like those studies with OCT from different manufactures. The reference limits at the 1st, 5th, 95th, and 99th percentile points establish the thresholds for the quantitative comparison of the cpRNFL and the macula in the human retina to a database of known healthy subjects. Keywords: spectral domain optical coherence tomography, normal eyes, 3D OCT-1 Maestro, macular measurements, circumpapillary retinal nerve fiber layer, optic disc