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BACKGROUND: The aim of the present study was to evaluate the ophthalmologic care in childhood and adolescence of infants born preterm and full-term from the retrospective point of view of their parents. METHODOLOGY: The Gutenberg Prematurity Eye Study (GPES) is a retrospective cohort study with a prospective ophthalmologic examination of persons born preterm and full-term between 1969 and 2002 (now aged 18 to 52 years), and asks their parents about the ophthalmologic care received by their children in childhood and adolescence from their retrospective perspective. Participants and their parents were grouped into those with normal gestational age (GA) ≥ 37 (control group), preterm born infants without retinopathy of prematurity (ROP) and gestational age (GA) 33â-â36 (group 2), GA 29â-â32 (group 3), GA ≤ 28 weeks (group 4), and those with ROP without treatment (group 5) and with ROP with treatment (group 6). Parents of participants were interviewed about the ophthalmic care received by their children. RESULTS: In total, data from 57 full-term and 131 preterm infants and their parents were included in the present study. The parents of the participants reported that ophthalmologic examination had taken place until 6 years of age in the respective groups 1 to 6 in 22/57 (38.6%), 33/58 (56.9%), 22/38 (57.9%), 3/6 (50%), 19/21 (90.5%), and 7/8 (87.5%). Overall, between 83% and 100% of parents in the different groups reported that ophthalmologic care had been adequate. A change of ophthalmologist due to dissatisfaction with treatment was reported by a total of 4/57 (7%), 9/58 (15.5%), 8/38 (21.1%), 1/6 (16.7%), 1/21 (4.8%) and 2/8 (25%) in the respective groups. DISCUSSION: The present study demonstrates adequate satisfaction and good treatment regarding ophthalmologic care of former preterm children from the parents' perspective. Especially parents of children with ROP rated the treatment positively.
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Recém-Nascido Prematuro , Retinopatia da Prematuridade , Criança , Recém-Nascido , Humanos , Lactente , Adolescente , Estudos Retrospectivos , Estudos Prospectivos , Idade Gestacional , Retinopatia da Prematuridade/diagnóstico , Retinopatia da Prematuridade/epidemiologia , Retinopatia da Prematuridade/terapia , Fatores de RiscoRESUMO
PURPOSE: To evaluate teprotumumab safety/efficacy in patients with thyroid eye disease (TED) who were nonresponsive or who experienced a disease flare. DESIGN: The Treatment of Graves' Orbitopathy to Reduce Proptosis with Teprotumumab Infusions in an Open-Label Clinical Extension Study (OPTIC-X) is a teprotumumab treatment and re-treatment trial following the placebo-controlled teprotumumab Phase 3 Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study (OPTIC) trial. PARTICIPANTS: Patients who previously received placebo (n = 37) or teprotumumab (n = 14) in OPTIC. METHODS: OPTIC nonresponders or those who flared (≥2-mm increase in proptosis, ≥2-point increase in clinical activity score [CAS], or both) during follow-up were treated for the first time (previous placebo patients) or re-treated with teprotumumab in OPTIC-X with 8 infusions over 24 weeks. MAIN OUTCOME MEASURES: Proptosis response and safety. Secondary outcomes included proptosis, CAS, subjective diplopia, and quality-of-life. RESULTS: Thirty-three of 37 placebo-treated OPTIC patients (89.2%) became proptosis responders (mean ± standard deviation, -3.5 ± 1.7 mm) when treated with teprotumumab in OPTIC-X. The responses were equivalent to the OPTIC study. In these responders, proptosis, CAS of 0 or 1, and diplopia responses were maintained in 29 of 32 patients (90.6%), 20 of 21 patients (95.2%), and 12 of 14 patients (85.7%), respectively, at follow-up week 48. The median TED duration was 12.9 months versus 6.3 months in those treated with teprotumumab in the OPTIC study. Of the 5 OPTIC teprotumumab nonresponders re-treated in OPTIC-X, 2 responded, 1 showed a proptosis reduction of 1.5 mm from OPTIC baseline, and 2 discontinued treatment early. Of the OPTIC teprotumumab responders who experienced flare, 5 of 8 patients (62.5%) responded when re-treated (mean proptosis reduction, 1.9 ± 1.2 mm from OPTIC-X baseline and 3.3 ± 0.7 mm from OPTIC baseline). Compared with published double-masked trials and their integrated follow-up, no new safety signals were identified. Mild hearing impairment was reported; 4 events occurred during the first course of treatment, and 2 events reoccurred after re-treatment. CONCLUSIONS: Patients with TED of longer disease duration responded similarly to those treated earlier in the disease course. Patients with an insufficient initial response or flare may benefit from additional teprotumumab therapy. No new safety risk was identified; however additional postmarketing pharmacovigilance is ongoing.
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Exoftalmia , Oftalmopatia de Graves , Anticorpos Monoclonais Humanizados/uso terapêutico , Diplopia , Oftalmopatia de Graves/tratamento farmacológico , HumanosRESUMO
PURPOSE: This study investigates the prevalence of manifest strabismus and its subtypes in adulthood and analyzes the risk factors and its impact on vision-related quality of life (VRQoL). DESIGN: The Gutenberg Health Study (GHS) is a population-based, observational cohort study. A cross-sectional analysis of the baseline examination was conducted. PARTICIPANTS: Participants aged 35 to 74 years were included (n = 15 010). METHODS: All participants were examined with a comprehensive ophthalmologic and general examination including the Hirschberg corneal reflex test to detect manifest strabismus. The following risk factors were analyzed: age, sex, socioeconomic status, birth weight, maternal age at birth, anisometropia, astigmatism, spherical equivalent, low visual acuity in the worse seeing eye (≥1.3 logMAR), and cardiovascular factors, and included in multivariable logistic regression analysis. Lifetime period prevalence and point prevalence of manifest strabismus were computed, and VRQoL was compared between participants with and without strabismus. MAIN OUTCOME MEASURE: Strabismus prevalence. RESULTS: A total of 14 700 participants (age, 55.0±11.1 years; 49.5% were female) were included in this analysis. The weighted prevalence of ever having strabismus was 2.9% (2.6%-3.2%), and the point prevalence for concomitant strabismus was 2.5% (2.3%-2.8%). Esotropia was twice as frequent as exotropia, and 2 participants had paralytic strabismus. Concomitant strabismus was associated with age 65 to 69 years (odds ratio [OR], 0.13 [0.05-0.39], P < 0.001); age 70 to 74 years (OR, 0.14 [0.05-0.4], P < 0.001); anisometropia (>1.0 diopters [D]: OR, 3.61 [2.32-5.62], P < 0.001; >2.0 D: OR, 6.93 [4.23-11.35], P < 0.001); astigmatism (≥1.0 D: OR, 2.09 [1.42-3.08], P < 0.001; ≥2.0 D: OR, 3.74 [2.35-5.97], P < 0.001); spherical equivalent (per diopter: OR, 1.43 [1.33-1.53], P < 0.001); and low visual acuity in the worse seeing eye (≥1.3 logMAR: OR, 21.7 [11.2-42.0], P < 0.001). VRQoL was lower in participants with strabismus compared with participants without strabismus in adjusted analysis (B = -5.96, P < 0.001). CONCLUSIONS: Strabismus is a frequent chronic eye condition that is associated with a lower VRQoL. Individuals with anisometropia, astigmatism, and hyperopia are more likely to have strabismus. In addition, low visual acuity in the worse eye was linked to strabismus prevalence.
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Vigilância da População , Qualidade de Vida , Estrabismo/epidemiologia , Acuidade Visual/fisiologia , Estudos Transversais , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estrabismo/psicologiaRESUMO
BACKGROUND: To estimate the effect of strabismus (squinting) on mental health and health-related quality of life aspects in children and adolescents. METHODS: Data from the German Health Interview and Examination Survey for Children and Adolescents KiGGS (2003-2006 baseline survey; N = 14,835, aged 3 to 17 years, 49% girls) were examined. The presence of strabismus was derived by parental questionnaire, and health-related quality of life and mental health were investigated with the KINDL-R and Strengths and Difficulties Questionnaire. Associations between strabismus and outcomes were analyzed using multivariable linear and logistic regression models. RESULTS: Of 12,989 children without missing data, 579 children (4.5% of the sample) were reported to have strabismus. Children with strabismus had lower scores in the parent-reported KINDL-R total scale (adjusted beta = - 1.02; 95%CI: -1.86 to - 0.18; p = 0.018) and sub-scale 'friends' (adjusted beta = - 2.18; 95%CI: -3.56 to -0.80; p = 0.002) compared to children without strabismus. The presence of strabismus was also associated with more mental health problems like 'hyperactivity/inattention' (adjusted OR = 1.50; 95%CI: 1.14 to 1.98; p = 0.005), and 'peer problems' (adjusted OR = 1.35; 95%-CI: 1.05 to 1.74; p = 0.018) as reported by parents. CONCLUSIONS: Strabismus in children and adolescents is associated with lower health-related quality of life.
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Qualidade de Vida , Estrabismo/psicologia , Adolescente , Estudos de Casos e Controles , Criança , Transtornos do Comportamento Infantil/epidemiologia , Pré-Escolar , Estudos Transversais , Feminino , Inquéritos Epidemiológicos , Humanos , Lactente , Modelos Logísticos , Masculino , Pais/psicologia , Estrabismo/complicações , Inquéritos e QuestionáriosRESUMO
PURPOSE: Most definitions of visual impairment focus on the status of the better-seeing eye only, but this approach might underestimate the influence of the worse-seeing eye on the vision-related quality of life (VRQoL). METHODS: We assessed distance-corrected visual acuity in both eyes and VRQoL using the "National Eye Institute 25-Item Visual Function Questionnaire" (NEI VFQ-25) in the German population-based Gutenberg Health Study. We calculated the Rasch-based visual functioning scale (VFS) and socioemotional scale (SES). We categorized the visual acuity of the better-seeing eye (BE) and worse-seeing eye (WE) as follows: (1) no visual impairment (VI) (< 0.32 logMAR)), (2) mild VI (0.32-0.5 logMAR), and (3) moderate to severe VI (> 0.5 logMAR). Next, the subjects were categorized as follows: both eyes with no VI (no/no), the better-seeing eye with no VI and the worse-seeing eye with mild VI (no/mild), no VI/severe VI (no/severe), both eyes with mild VI (mild/mild), light VI/severe VI (mild/severe), and both eyes with severe VI (severe/severe). We calculated the median scores for VFS and SES. We used linear regression to estimate the combined influence of BE/WE on VFS and SES. RESULTS: We included 11,941 participants (49.9% female, age range: 35-74 years) with information on VRQoL and visual acuity. The median VFS/SES scores were 90/100 (no/no VI group), 84/97 (no/mild group), 81/94 (no/severe group), 70/90 (mild/mild group), 67/74 (mild/severe group), and 63/76 (severe/severe group). These differences were supported by the regression analysis results. CONCLUSION: Relying on the function of the better-seeing eye considerably underestimates the impact of visual impairment on VRQoL.
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Qualidade de Vida , Inquéritos e Questionários/normas , Transtornos da Visão/psicologia , Acuidade Visual , Adulto , Idoso , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Análise de RegressãoRESUMO
BACKGROUND: The purpose of this investigation was to analyse the ophthalmic follow-up care of former pre-term and full-term born infants aged 4 to 10 years in the clinical practice and the comparison to the recommendations of the national ophthalmic guidelines. METHODS: For the prospective Wiesbaden Prematurity Study (WPS), 503 infants were examined: 239 former pre-term infants (PT) with gestational age (GA) ≤ 32 weeks and 264 former full-term born infants (FT) with a GA ≥ 37 weeks aged 4 to 10 years. Ophthalmic examination was performed including refractive measurements and orthoptic examination. Anisometropia was defined as a difference of ≥ 1 D spherical equivalent. Data was assessed if an ophthalmological examination was performed after hospital discharge, and how many times the ophthalmologist was contacted within the last 12 months. RESULTS: Overall, strabismus and anisometropia were present in 18 and 10% of all PT, and in 2 and 5% of all FT infants, respectively. In infants aged 4 to 6 years, 65% of all former PT and 42% of all former FT had ophthalmological contacts within the last year (p = 0.002). 15% of the pre-term infants with strabismus did not have an ophthalmological examination within the last year. The parents of three former pre-term infants reported that they never had an ophthalmologic examination after hospital discharge. CONCLUSION: Two-thirds of the former pre-term infants participated in a screening examination at the age of 4 to 6 years in the last year according to their parents, which is recommended by the guidelines for the care of former pre-term infants. There is still room for improvement to provide best ophthalmological care for this vulnerable population that have high risk for strabismus and amblyopia.
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Assistência ao Convalescente , Técnicas de Diagnóstico Oftalmológico , Oftalmopatias/diagnóstico , Recém-Nascido Prematuro , Criança , Pré-Escolar , Alemanha , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Estudos ProspectivosRESUMO
Purpose To determine the population prevalence and risk factors of myopia in children and adolescents in Germany. Methods The prevalence of myopia in Germany was computed using data from the 2003-2006 German Health Interview and Examination Survey for Children and Adolescents (N=17 640, 49% girls). Status of myopia was derived from parental questionnaire responses for myopia and the use of spectacles. Potential risk factors were identified using directed acyclic graphs and evaluated using multivariable logistic regression analysis. Results The population prevalence of myopia in the age group 3-17 years was estimated at 13.3% (95%-confidential interval 12.6-14.0%). In the age group 3-10 years, myopia was positively associated with age (per 2 years: OR=1.78 [1.59; 2.00]) and negatively associated with male gender (OR=0.73 [0.57; 0.95]), but neither with leisure-time activities nor with media use. In the age group 11-17 years, attending a High School was positively associated with myopia (OR=1.69 [1.32; 2.16]), while regular physical activity (OR=0.67 [0.53; 0.84]) was negatively associated. Media use was not associated. Conclusions In Germany, myopia is one of the most frequent chronic medical conditions among children and adolescents. Girls, adolescents, and pupils attending a Gymnasium are at higher risk of developing myopia while being physically active may be protective.
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Miopia/epidemiologia , Miopia/etiologia , Adolescente , Fatores Etários , Criança , Pré-Escolar , Estudos Transversais , Exercício Físico , Óculos/estatística & dados numéricos , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Miopia/terapia , Fatores de Risco , Fatores Sexuais , Revisão da Utilização de Recursos de SaúdeRESUMO
OBJECTIVES: To estimate the prevalence of strabismus in children and adolescents in Germany and to determine the associated risk factors, particularly those related to early childhood development. METHODS: In the German Health Interview and Examination Survey for Children and Adolescents (KiGGS, baseline survey 2003 to 2006, N = 17,640, 49.1% girls), the presence of strabismus and potential risk factors were derived using parental questionnaires. The analyses were performed using the KIGGS public use file. The following relevant factors were analyzed: smoking during pregnancy, gestational age at birth, birth weight, medical problems within the first four weeks of life, and officially confirmed disability. Associations with strabismus were evaluated using multivariable logistic regression analysis. Odds ratios and 95% confidence intervals [95%-CI] were calculated and adjusted for age, sex, socio-economic status, migrational background, and participation in regular pediatric checkups. RESULTS: The prevalence of strabismus was estimated to be 4.1% [3.7-4.5]. Boys had a slightly lower prevalence (3.7%; [3.3-4.2%]) compared to girls (4.4%; [3.9-5.0%]; p value > 0.05). After adjusting for confounders, strabismus was found to be significantly associated with smoking during pregnancy (OR = 1.38; [1.08-1.78]), gestational age (OR = 0.91 per week; [0.86-0.96]), medical problems within the first four weeks of life (OR = 1.29; [1.01-1.65]) and disability (OR = 4.33; [2.81-6.67]), but not with other risk factors under study. CONCLUSIONS: In Germany, strabismus is among the most prevalent chronic eye conditions. Former preterm infants and disabled children and adolescents are at greater risk.
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Inquéritos Epidemiológicos , Estrabismo/epidemiologia , Adolescente , Criança , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Razão de Chances , Gravidez , Efeitos Tardios da Exposição Pré-Natal/epidemiologia , Fatores de Risco , Fatores Sexuais , Fumar/efeitos adversos , Estrabismo/etiologiaRESUMO
PURPOSE: To investigate whether the experience of visual hallucinations, namely Charles Bonnet's syndrome, in psychologically healthy people is a phenomenon solely of elderly, visually impaired people. METHODS: In a prospective controlled study, four groups of subjects (total 324) were formed: age ≤40 years, no visual impairment; age ≤40 years, visually impaired; age >40 years, no visual impairment; age >40 years, visually impaired. Visual impairment was defined as best-corrected visual acuity ≤0.3 (Snellen) in the better-seeing eye. Each group consisted of 81 subjects. Visual hallucinations were defined as complex visual perceptions. After ruling out psychiatric causes for visual hallucinations or medication related to the experience of visual hallucinations, affected subjects underwent a detailed interview about their visual hallucinations. RESULTS: The prevalence of visual hallucinations among young subjects with visual impairment was 4.9 %; among the elderly visually impaired subjects, it was 6.2 %. The difference was not statistically significant. No subject without visual impairment experienced visual hallucinations. CONCLUSIONS: Charles Bonnet's syndrome is not limited to elderly people suffering from visual impairment, though there tends to be a higher prevalence of visual hallucinations in this group.
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Alucinações/etiologia , Transtornos da Visão/etiologia , Acuidade Visual , Percepção Visual/fisiologia , Pessoas com Deficiência Visual/psicologia , Adolescente , Adulto , Distribuição por Idade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Alemanha/epidemiologia , Alucinações/epidemiologia , Alucinações/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Síndrome , Transtornos da Visão/epidemiologia , Transtornos da Visão/fisiopatologia , Adulto JovemRESUMO
AIM: The purpose of this study was to assess the prevalence of strabismus and nystagmus and to analyse associated factors in preterm and full-term infants in adulthood. METHODS: The Gutenberg Prematurity Eye Study is a retrospective cohort study with a prospective ophthalmological examination of participants born preterm and full-term (aged 18-52 years). Perinatal data were carefully assessed for risk factors and comprehensive ophthalmological examinations were conducted. The association between strabismus and nystagmus was assessed by analysing 16 different perinatal and actual risk factors in multivariable analysis. Participants were grouped into full-term controls (gestational age (GA) at birth ≥37 weeks), preterm participants without retinopathy of prematurity (ROP) and GA 33-36 weeks (group 2), GA 29-32 weeks (group 3), GA ≤28 weeks (group 4), non-treated ROP (group 5) and treated ROP (group 6). RESULTS: In total, 892 eyes of 450 preterm and full-term individuals (mean age: 28.6 years, SD: ± 8.6 years, 251 females) were included. Strabismus was observed in 2.1% (3/140), 6.6% (9/137), 17.4% (16/92), 11.1% (2/18), 27.1% (13/48) and 60% (9/15) of participants and nystagmus in 0.7% (1/140), 1.5% (2/137), 4.3% (4/92), 5.6% (1/18), 10.4% (5/48) and 26.7% (4/15) of participants in the respective groups. In the multivariable regression model, strabismus was associated with GA (OR=0.90; p=0.046), anisometropia ≥1.5 diopter (OR=3.87; p=0.003), hypermetropia ≥2 diopter (OR=9.89; p<0.001) and astigmatism ≥1.5 diopter (OR=2.73; p=0.017). Esotropia was more frequent than exotropia and hypermetropia/hypometropia. Most strabismus cases occurred within the first 10 years of life. The strongest predictor associated with nystagmus was perinatal adverse events (OR=15.8; p=0.002). CONCLUSION: Low GA and refraction of the eye are independent risk factors for strabismus, which typically occurs in the first 10 years of life. Perinatal adverse events are the most important factors for the presence of nystagmus in adulthood.
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OBJECTIVES: This study investigated the effects of prematurity and ROP on visual acuity and VRQoL in adults (18-52 years). METHODS: The Gutenberg Prematurity Eye Study is a retrospective cohort study with a prospective ophthalmologic examination. Preterm and full-term participants at an age from 18 to 52 years were included. Distant corrected visual acuity (DCVA) and VRQoL were assessed in participants (892 eyes of 450 individuals aged 28.6 ± 8.6 years, 251 females) grouped into full-term controls (gestational age [GA] at birth ≥37 weeks), preterm participants without ROP and GA 33-36 weeks (group 2), GA 29-32 weeks (group 3), GA ≤ 28 weeks (group 4), non-treated ROP (group 5) and treated ROP (group 6). Main outcome measures were distant corrected visual acuity (DCVA), VRQoL and prevalence of amblyopia. RESULTS: The DCVA of the better eye correlated (p < 0.001) with GA, birth weight, ROP, ROP treatment, and perinatal adverse events and was poorer in both ROP groups. Visual acuity of <20/200 in the better eye was observed in two participants (4.2%) in the ROP group and one person (6.7%) in the treated ROP group. The prevalence of amblyopia increased in the ROP groups. Compared to full-term controls, visual functioning VRQoL scores were lower in preterm individuals independent of ROP while socioemotional VRQoL scores were only lower in the treated ROP group. CONCLUSION: Participants with postnatal ROP and its treatment showed decreased visual acuity and VRQol in adulthood, with amblyopia occurring more frequently in more preterm participants with ROP.
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Ambliopia , Retinopatia da Prematuridade , Recém-Nascido , Feminino , Humanos , Adulto , Ambliopia/epidemiologia , Estudos Prospectivos , Estudos Retrospectivos , Qualidade de Vida , Retinopatia da Prematuridade/complicações , Retinopatia da Prematuridade/epidemiologia , Acuidade Visual , Idade GestacionalRESUMO
BACKGROUND: Prematurity and the presence of retinopathy of prematurity (ROP) increase the risk for the occurrence of amblyogenic risk factors in childhood and adolescence. AIM: The aim of the present study was to evaluate ocular morbidities and the ophthalmological care of former preterm and full-term persons in adulthood. MATERIAL AND METHODS: The Gutenberg prematurity eye study (GPES) is a retrospective cohort study with a prospective ophthalmological examination of individuals formerly born preterm and full term between 1969 and 2002 (now aged 18-52 years). All participants underwent a detailed ophthalmological examination and were asked about the frequency of ophthalmological care. Participants were grouped into those with normal gestational age (GA)â¯≥ 37 weeks (control group), preterm individuals without ROP and GA 33-36 weeks (group 2), GA 29-32 weeks (group 3), GAâ¯≤ 28 weeks (group 4), and those with ROP without treatment (group 5) and with ROP with treatment (group 6). All participants were asked if they had an ophthalmological examination within the last 12 months. RESULTS: In total, data from 140 term and 310 preterm adults were included in the present study. Strabismus was present in 2.1â¯% (3/140), 6.6â¯% (9/137), 17.4â¯% (16/92), 11.1â¯% (2/18), 27.1â¯% (13/48) and 60â¯% (9/15) in groups 1-6, respectively. The proportion of subjects with an ophthalmological examination within the last 12 months was highest in the groups of extremely preterm persons with and without ROP compared with the control group. Overall, 33.3â¯% (1/3) of the term and 57.1â¯% (28/49) of the preterm subjects with strabismus and 0â¯% (0/3) of the term and 46.9â¯% (15/32) of the preterm individuals with amblyopia had an ophthalmological examination within the past 12 months. DISCUSSION: Extremely preterm adults with and without postnatal ROP showed the highest rate of eye diseases as well as the highest rate of ophthalmological check-ups within the last 12 months. This suggests that extremely preterm adults particularly with the occurrence of postnatal ROP perceive more frequent ophthalmological check-ups throughout their lives.
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Nascimento Prematuro , Retinopatia da Prematuridade , Estrabismo , Recém-Nascido , Feminino , Humanos , Adulto , Estudos Prospectivos , Estudos Retrospectivos , Recém-Nascido Prematuro , Estrabismo/epidemiologia , Retinopatia da Prematuridade/diagnósticoRESUMO
CONTEXT: Inhibition of the neonatal fragment crystallizable receptor (FcRn) reduces pathogenic thyrotropin receptor antibodies (TSH-R-Ab) that drive pathology in thyroid eye disease (TED). OBJECTIVE: We report the first clinical studies of an FcRn inhibitor, batoclimab, in TED. DESIGN: Proof-of-concept (POC) and randomized, double-blind placebo-controlled trials. SETTING: Multicenter. PARTICIPANTS: Patients with moderate-to-severe, active TED. INTERVENTION: In the POC trial, patients received weekly subcutaneous injections of batoclimab 680 mg for 2 weeks, followed by 340 mg for 4 weeks. In the double-blind trial, patients were randomized 2:2:1:2 to weekly batoclimab (680 mg, 340 mg, 255 mg) or placebo for 12 weeks. MAIN OUTCOME: Change from baseline in serum anti-TSH-R-Ab and total IgG (POC); 12-week proptosis response (randomized trial). RESULTS: The randomized trial was terminated because of an unanticipated increase in serum cholesterol; therefore, data from 65 of the planned 77 patients were analyzed. Both trials showed marked decreases in pathogenic anti-TSH-R-Ab and total IgG serum levels (P < .001) with batoclimab. In the randomized trial, there was no statistically significant difference with batoclimab vs placebo in proptosis response at 12 weeks, although significant differences were observed at several earlier timepoints. In addition, orbital muscle volume decreased (P < .03) at 12 weeks, whereas quality of life (appearance subscale) improved (P < .03) at 19 weeks in the 680-mg group. Batoclimab was generally well tolerated, with albumin reductions and increases in lipids that reversed upon discontinuation. CONCLUSIONS: These results provide insight into the efficacy and safety of batoclimab and support its further investigation as a potential therapy for TED.
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Exoftalmia , Oftalmopatia de Graves , Recém-Nascido , Humanos , Oftalmopatia de Graves/tratamento farmacológico , Qualidade de Vida , Anticorpos Monoclonais/uso terapêutico , Imunoglobulina G/uso terapêutico , Método Duplo-Cego , Resultado do TratamentoRESUMO
BACKGROUND: By identifying diseases of the anterior segment of the eye associated with exposure to UV light, recommendations for action can be derived. AIM: After reading this review, the reader should be familiar with UV light-associated diseases of the anterior segment of the eye. METHOD: Using a selective literature search, UV light-associated diseases of the anterior segment of the eye were identified and protective mechanisms are described. RESULTS: The UV light-associated lesions of the anterior segment of the eye include basal cell and squamous cell carcinomas, malignant melanoma of the eyelids and conjunctiva, pterygium, keratoconjunctivitis photoelectrica and climatic droplet keratopathy as well as cortical cataract. CONCLUSION: Eyeglasses for filtering UV light, sunglasses and special safety glasses, such as welding helmets and wearing headgear protect against UV light exposure to the anterior segment of the eye and the associated diseases.
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Catarata , Ceratoconjuntivite , Pterígio , Catarata/etiologia , Óculos , Humanos , Ceratoconjuntivite/etiologia , Raios Ultravioleta/efeitos adversosRESUMO
PURPOSE: To determine whether prematurity and associated factors affect the anterior chamber angle (ACA) width in adulthood. METHODS: The Gutenberg Prematurity Eye Study (GPES) is a retrospective cohort study with a prospective ophthalmologic examination of adults (age 18-52 years) in Germany. All participants were examined with Scheimpflug imaging (Pentacam HR, Oculus Optikgeräte GmbH, Wetzlar, Germany) using linear regression analysis to assess the associations of ACA in the different sectors with gestational age (GA), birth weight, birth weight percentile, retinopathy of prematurity (ROP), ROP treatment, placental insufficiency, preeclampsia, and breastfeeding. RESULTS: In total, 516 eyes of 319 preterm and full-term individuals (aged 28.9 ± 8.8 years, 188 females) were examined. ROP treatment was associated with smaller ACA width in the nasal (B = -9.6 [95%CI: -14.7; -4.5] degree; p < 0.001) and temporal positions (B = -11.5 [95%CI: -17.7; -5.3] degree; p = 0.001), whereas non-treated individuals with ROP had an unaltered ACA width, as did individuals with low gestational age without ROP. CONCLUSION: Advanced stages of ROP following treatment with laser- and cryocoagulation lead to a smaller ACA width until adulthood, and hence may increase the risk of angle closure in later life.
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Background: Thyroid eye disease (TED) involves several pathogenic pathways and a battery of infiltrating mononuclear cells, cytokines, and chemokines in the orbit. Revealing the main molecules, which play a major role in the pathogenesis of TED, will help developing novel treatment strategies. Methods: In a multicenter, single-blind, case-control study, 60 tissue samples were collected during orbital decompression (44 TED patients) or non-TED related oculoplastic (16 controls) surgeries. Formalin-fixation and paraffin embedding preserved orbital tissue. Tissue sections were immunostained with 18 antibodies by the micro-polymer labeling technique. Immunostaining slides were scanned by Panoramic Desk and blindly evaluated by a user-independent viewer software. Results: Marked lymphocyte infiltration was observed in orbital tissue specimens of patients with clinically active TED (n = 22) and to a much lesser extent in inactive cases (n = 22), while it was absent in controls. Increased vascularity was noted in all samples, with orbital congestion in specimens of clinically active TED. Tissue fibrosis was present in TED samples but not in controls. Immunohistochemistry of orbital tissue clearly differentiated between TED and controls, as well as between active and inactive TED. In contrast to controls and with the exception of cluster of differentiation 20 (CD20), 17 out of 18 antibodies were highly expressed in orbital connective tissue of TED patients. Especially, thyrotropin receptor (TSH-R), insulin-like growth factor 1 receptor (IGF-1R), CD40, cluster of differentiation 40 ligand (CD40L), CD3, CD68, interleukin-17A (IL-17A), IL-23A, IL-1ß, IL-4, regulated on activation, normal T cell expressed and secreted (RANTES), macrophage chemoattractant protein 1 (MCP-1), IL-16, and B cell activating factor (BAFF) were overexpressed in clinically active TED (all p < 0.001). Also, the expression of CD40L, IL-17A, IL-23A, IL-6, IL-1ß, RANTES, and BAFF was very high (TED/control ratio >3), moderate (ratio >2), and low in active (p < 0.001), inactive TED and controls, respectively. The expression of TSH-R, IGF-1R, CD40, CD40L, CD3, CD68, CD20, IL-17A, IL-23A, RANTES, MCP-1, and BAFF positively and significantly correlated with both serum TSH-R stimulatory antibody concentrations and clinical activity scores while it negatively correlated with TED duration. Orbital irradiation decreased TSH-R (p < 0.001) and IGF-1R expression (p = 0.012); in contrast, neither smoking, age, nor gender did impact immunohistochemical staining. Conclusions: Adaptive and cell-mediated immunity, overexpression of TSH-R/IGF-1R and CD40/CD40L are the relevant pathomechanisms in TED. Targeting these key players in the active phase of the disease offers specific and novel treatment approaches.
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Oftalmopatia de Graves , Humanos , Oftalmopatia de Graves/metabolismo , Interleucina-17 , Ligante de CD40 , Estudos de Casos e Controles , Método Simples-Cego , Receptores da Tireotropina , TireotropinaRESUMO
BACKGROUND: Within the framework of the German pediatric screening examinations, the checks include visual functions. There is no ophthalmological screening examination in childhood in Germany. This study investigated whether participation in the pediatric screening examinations U8 (at the end of the fourth year of life) and U9 (at the beginning of the sixth year of life) is associated with the results of visual acuity, which are compiled at the school entry examinations (SEU). METHODS: This study evaluated data of the SEU for school the enrollment years 2009/2010-2014/2015 of the State of Rhineland-Palatinate. In these years visual acuity was assessed using the Rodenstock visual testing device (E-hooks; Rodenstock intruments GmbH, Ottobrunn, Deutschland) wearing glasses if present. The association between participation in the U8 and U9 screening examinations and the presence of unilateral and bilateral visual acuity <0.7 was investigated using multiple logistic regression adjusted for important disturbance variables. RESULTS: Data from 189,704 children (91,041 girls, 98,663 boys) from 35 out of 36 districts were included. A visual acuity <0.7 was measured in 8416 (4.4%) children and in both eyes in 4345 (2.3%) children. The participation rates in the U8 and U9 were 93.9% and 93.3%, respectively. There was a negative association between participation in the U8 and U9 and a unilateral or bilateral SEU visual acuity <0.7 (adjusted odds ratio, OR 0.68, 95% confidence interval, CI 0.61-0.75; pâ¯< 0.01, Nâ¯= 124,467/adjusted OR 0.57, 95% CI 0.51-0.65; pâ¯< 0.01, Nâ¯= 121,496). CONCLUSION: The proportion of children with visual acuity <0.7 at the SEU was high. Children who were examined in the U8 and U9 had a better chance for a good visual acuity in the school entry examination.
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Ambliopia , Seleção Visual , Criança , Pré-Escolar , Estudos Transversais , Óculos , Feminino , Alemanha , Humanos , Masculino , Testes Visuais , Acuidade VisualRESUMO
BACKGROUND: Endocrine orbitopathy (EO) encompasses functional and cosmetic limitations. The aim of this study was to assess the health services situation of patients with EO treated at a multidisciplinary specialized center. METHODS: The medical records pertaining to the clinical spectrum, access route, and medical specialty of the referring physician of patients who were treated within a period of 5 years at a tertiary referral orbit center were systematically assessed. RESULTS: A total of 431 subjects with EO (female nâ¯=354, 82%; median age 40 years, range 5-79 years) were included in the study. Of the patients 148 (35%) and 123 (29%) were referred by family physicians and ophthalmologists, respectively. A sight-threatening optic nerve neuropathy was present in 11 (14.3%) men and 21 (5.9%) women (pâ¯=0.011). At least 2 other autoimmune diseases were found in 8 (10.4%) men and in 15 (4.3%) women (pâ¯=0.079). Psychotherapeutic support was utilized by 2 (2.6%) men and 92 (26%) women (pâ¯<0.001). An access route of 50â¯km or more was accepted by 14 (28%) men and 83 (43%) women (pâ¯=0.054). There was also an association between an access route ≥100â¯km and a prior medical treatment (odds ratio 3.78, 95% confidence interval 1.18-12.05, pâ¯=0.025). CONCLUSION: Men were more severely affected by EO than women and often had complex autoimmune diseases; however, male patients were less frequently willing to accept long access routes and barely used psychosocial support. Especially patients with further autoimmune diseases travelled long distances to be treated at a specialized center.
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Oftalmopatia de Graves , Doenças do Nervo Óptico , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Oftalmopatia de Graves/diagnóstico , Oftalmopatia de Graves/epidemiologia , Oftalmopatia de Graves/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Nervo Óptico , Órbita , Encaminhamento e Consulta , Adulto JovemRESUMO
BACKGROUND: Myopia (near-sightedness) is increasing worldwide, especially in Asia. The aim of this study was to describe trends in the prevalence of myopia in Germany. METHODS: We analyzed data from the German Health Interview and Examination Survey for Children and Adolescents (KiGGS; baseline survey 2003-2006, N = 17 640; wave 2, 2014-2017, N = 15 023). The presence of myopia was determined from a parent questionnaire and validated by the use of a visual aid. The population prevalence of myopia was calculated. Based on the KiGGS wave 2 data, potential risk factors for myopia were identified by means of logistic regression. RESULTS: The prevalence of myopia at the age of 0-17 years in Germany was 11.6% (95% confidence interval [11.0; 12.2]) in the period 2003-2006 and 11.4% [10.7; 12.2] in 2014-2017. No age group of either sex exhibited a relevant, statistically significant change in the prevalence of myopia. In the adjusted model (adjusted for age, sex, family socioeconomic status, family history of migration), no association was found between myopia and use of digital media. More time spent reading books was associated with myopia: reading for more than 2 h/day showed an odds ratio of 1.69 [1.3; 2.2]. CONCLUSION: The prevalence of myopia in children and adolescents in Germany has remained virtually unchanged over a period of approximately 10 years. Changes in media consumption, such as the increased use of smartphones in this age group, have therefore had no detectable impact on the development of myopia, at least not so far. Future studies should investigate the influences of further increases in media use and examine the long-term effects.
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Internet , Miopia , Adolescente , Ásia , Criança , Pré-Escolar , Estudos Transversais , Alemanha/epidemiologia , Inquéritos Epidemiológicos , Humanos , Lactente , Recém-Nascido , Miopia/epidemiologia , Prevalência , Fatores de RiscoRESUMO
BACKGROUND: The newly introduced German pediatric screening examination at the end of the third year of life (U7a) incorporates visual function testing in particular; there is no ophthalmic screening during childhood in Germany. The purpose of this study is to investigate the relationship between participation in U7a and visual function at the preschool health examination (PHE) in the sixth year of life. METHODS: This study evaluated PHE data from school enrollment years 2009/2010 to 2014/2015 of Rhineland-Palatinate, Germany. Visual acuity (VA) at PHE was assessed with Rodenstock visual acuity test device (tumbling E) wearing glasses if present. The relationship between participation in U7a and VA <0.7 at PHE was calculated for reduced monocular and binocular VA using multiple logistic regression adjusted for potential confounders. RESULTS: Data from 189,704 children (91,041 girls) in 35 out of 36 districts were included. The first children to participate in U7a were enrolled in 2011/2012 school year. In total, 90,339 children (47.6%) had U7a before PHE, while 99,365 (52.4%) had not. VA <0.7 in at least one eye was measured at PHE in 8429 (4.4%) children, and in both eyes in 4345 (2.3%) children. Participation in U7a was not associated with VA <0.7 at PHE (odds ratio 0.99; 95% confidence interval: 0.94-1.04). CONCLUSIONS: The proportion of children with VA <0.7 at PHE was high. No beneficial effect of newly introduced German U7a pediatric screening examination was found for reduced VA at PHE.