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3. Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment: OPTIC-X Study

Author

Douglas, Raymond S., Kahaly, George J., Ugradar, Shoaib, Elflein, Heike, Ponto, Katharina A., Fowler, Brian T., Dailey, Roger, Harris, Gerald J., Schiffman, Jade, Tang, Rosa, Wester, Sara, Jain, Amy Patel, Marcocci, Claudio, Marinò, Michele, Antonelli, Alessandro, Eckstein, Anja, Führer-Sakel, Dagmar, Salvi, Mario, Sile, Saba, Francis-Sedlak, Megan, Holt, Robert J., and Smith, Terry J.

Published
2022
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4. Prevalence of strabismus and risk factors in adults born preterm with and without retinopathy of prematurity: results from the Gutenberg Prematurity Eye study.

Author

Fieß, Achim, Dautzenberg, Kim, Gißler, Sandra, Mildenberger, Eva, Urschitz, Michael S., Elflein, Heike M., Laspas, Panagiotis, Stoffelns, Bernhard M., Pfeiffer, Norbert, and Schuster, Alexander K.

Abstract

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. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Safety and efficacy of erythropoietin for the treatment of patients with optic neuritis (TONE): a randomised, double-blind, multicentre, placebo-controlled study

Author

Albrecht, Philipp, Aktas, Orhan, Beck, Anna, Beckmann, Anke, Beisse, Flemming, Berthele, Achim, Bönig, Lena, Diem, Ricarda, Elflein, Heike, Fitzner, Dirk, Fleischer, Vinzenz, Gingele, Stefan, Grotejohann, Birgit, Guthoff, Tanja, Guthoff, Rainer, Hartmann, Kathrin, Hassenstein, Andrea, Heesen, Christoph, Hein, Katharina, Heinrich, Sven P., Hufendiek, Karsten, Hug, Martin J., Huhn, Konstantin, Hümmert, Martin W., Ihorst, Gabriele, Klopfer, Matthias, Kruse, Friedrich E., Küchlin, Sebastian, Kümpfel, Tania, Lagrèze, Wolf A., Linker, Ralf A., Lorenz, Katrin, Molnár, Fanni E., Mulazzani, Elisabeth, Müller, Marcus, Nickel, Florian T., Noll, Marion, Pielen, Amelie, Pitz, Susanne, Rauer, Sebastian, Reich, Michael, Rosenkranz, Sina, Schwenkenbecher, Philipp, Siller, Nelly, Skripuletz, Thomas, Stangel, Martin, Stellmann, Jan-Patrick, Stürner, Klarissa, Sühs, Kurt-Wolfram, Ungewiss, Judith, Uphaus, Timo, van Oterendorp, Christian, Volkmann, Martin, Wabbels, Bettina, Wilhelm, Helmut, Wolf, Sebastian, Wörner, Michael, Ziemann, Ulf, Zipp, Frauke, Lagrèze, Wolf A, Heinrich, Sven P, and Hug, Martin J

Published
2021
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13. Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease

Author

Kahaly, George J, primary, Dolman, Peter J, additional, Wolf, Jan, additional, Giers, Bert C, additional, Elflein, Heike M, additional, Jain, Amy P, additional, Srinivasan, Ashok, additional, Hadjiiski, Lubomir, additional, Jordan, David, additional, Bradley, Elizabeth A, additional, Stan, Marius N, additional, Eckstein, Anja, additional, Pitz, Susanne, additional, Vorländer, Christian, additional, Wester, Sara T, additional, Nguyen, John, additional, Tucker, Nancy, additional, Sales-Sanz, Marco, additional, Feldon, Steven E, additional, Nelson, Christine C, additional, Hardy, Isabelle, additional, Abia-Serrano, Maravillas, additional, Tedeschi, Philip, additional, Janes, Jonathan M, additional, Xu, Jing, additional, Vue, Peter, additional, Macias, William L, additional, and Douglas, Raymond S, additional

Published
2023
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18. Augenärztliche Versorgung ehemaliger früh- und reifgeborener Personen im Erwachsenenalter – Ergebnisse der Gutenberg Prematurity Eye Study (GPES)

Author

Fieß, Achim, primary, Wacker, Annika, additional, Gißler, Sandra, additional, Fauer, Agnes, additional, Mildenberger, Eva, additional, Urschitz, Michael S., additional, Elflein, Heike, additional, Stoffelns, Bernhard, additional, Pfeiffer, Norbert, additional, and Schuster, Alexander K., additional

Published
2022
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24. Alterations of the anterior segment of the eye caused by exposure to UV radiation

Author

Hampel, Ulrike, Elflein, Heike M., Kakkassery, V., Heindl, Ludwig M., Schuster, Alexander K., Hampel, Ulrike, Elflein, Heike M., Kakkassery, V., Heindl, Ludwig M., and Schuster, Alexander K.

Abstract

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.

Published
2022

28. Anterior Chamber Angle in Adults Born Extremely, Very, and Moderately Preterm with and without Retinopathy of Prematurity—Results of the Gutenberg Prematurity Eye Study

Author

Fieß, Achim, primary, Gißler, Sandra, additional, Mildenberger, Eva, additional, Urschitz, Michael S., additional, Fauer, Agnes, additional, Elflein, Heike M., additional, Zepp, Fred, additional, Stoffelns, Bernhard, additional, Pfeiffer, Norbert, additional, and Schuster, Alexander K., additional

Published
2022
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32. Safety and efficacy of erythropoietin for the treatment of patients with optic neuritis (TONE): a randomised, double-blind, multicentre, placebo-controlled study

Author

Lagrèze, Wolf A, primary, Küchlin, Sebastian, additional, Ihorst, Gabriele, additional, Grotejohann, Birgit, additional, Beisse, Flemming, additional, Volkmann, Martin, additional, Heinrich, Sven P, additional, Albrecht, Philipp, additional, Ungewiss, Judith, additional, Wörner, Michael, additional, Hug, Martin J, additional, Wolf, Sebastian, additional, Diem, Ricarda, additional, Aktas, Orhan, additional, Beck, Anna, additional, Beckmann, Anke, additional, Berthele, Achim, additional, Bönig, Lena, additional, Elflein, Heike, additional, Fitzner, Dirk, additional, Fleischer, Vinzenz, additional, Gingele, Stefan, additional, Guthoff, Tanja, additional, Guthoff, Rainer, additional, Hartmann, Kathrin, additional, Hassenstein, Andrea, additional, Heesen, Christoph, additional, Hein, Katharina, additional, Heinrich, Sven P., additional, Hufendiek, Karsten, additional, Hug, Martin J., additional, Huhn, Konstantin, additional, Hümmert, Martin W., additional, Klopfer, Matthias, additional, Kruse, Friedrich E., additional, Kümpfel, Tania, additional, Lagrèze, Wolf A., additional, Linker, Ralf A., additional, Lorenz, Katrin, additional, Molnár, Fanni E., additional, Mulazzani, Elisabeth, additional, Müller, Marcus, additional, Nickel, Florian T., additional, Noll, Marion, additional, Pielen, Amelie, additional, Pitz, Susanne, additional, Rauer, Sebastian, additional, Reich, Michael, additional, Rosenkranz, Sina, additional, Schwenkenbecher, Philipp, additional, Siller, Nelly, additional, Skripuletz, Thomas, additional, Stangel, Martin, additional, Stellmann, Jan-Patrick, additional, Stürner, Klarissa, additional, Sühs, Kurt-Wolfram, additional, Uphaus, Timo, additional, van Oterendorp, Christian, additional, Wabbels, Bettina, additional, Wilhelm, Helmut, additional, Ziemann, Ulf, additional, and Zipp, Frauke, additional

Published
2021
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33. Visual acuity, amblyopia, and vision-related quality of life in preterm adults with and without ROP: results from the Gutenberg prematurity eye study

Author

Fieß, Achim, Greven, Katrin, Mildenberger, Eva, Urschitz, Michael S., Elflein, Heike M., Zepp, Fred, Stoffelns, Bernhard, Pfeiffer, Norbert, and Schuster, Alexander K.

Abstract

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&lt; 0.001) with GA, birth weight, ROP, ROP treatment, and perinatal adverse events and was poorer in both ROP groups. Visual acuity of &lt;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.

Published
2023
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34. Age at school entry and reported symptoms of attention-deficit/hyperactivity in first graders: results of the prospective cohort study ikidS.

Author

Diefenbach, Christiane, Schmidt, Martina F., Huss, Michael, König, Jochem, Urschitz, Michael S., The ikidS Study Group, Hoffmann, Dietmar, Blettner, Maria, Queisser-Wahrendorf, Annette, Wiesel, Awi, Zepp, Fred, Faber, Jörg, Gehring, Stephan, Mildenberger, Eva, Letzel, Stephan, Elflein, Heike, Schuster, Alexander K., Willershausen, Brita, Weusmann, Jens, and Matthias, Christoph

Subjects
PARENT attitudes, AGE distribution, PSYCHOLOGY of teachers, ATTENTION-deficit hyperactivity disorder, QUESTIONNAIRES, DESCRIPTIVE statistics, SCHOOL children, SECONDARY analysis, SYMPTOMS, CHILDREN
Abstract

Young age at school entry (ASE) is related to attention-deficit/hyperactivity disorder in higher grades. The reason for this association is unclear, but medical oversupply and stress-related factors are discussed. We aimed to investigate whether ASE is associated with reported symptoms of attention-deficit/hyperactivity (ADH) already in first grade. Data of a population-based prospective cohort study (N = 2003; Mainz-Bingen region; Rhineland-Palatinate; Germany) with baseline assessments prior to school entry and two follow-ups during first grade were analysed. ADH symptoms were assessed by parent and teacher versions of the Strengths and Difficulties Questionnaire. Associations between ASE and scores of the hyperactivity/inattention subscale (range 0–10) were investigated by regression analysis and adjusted for potential confounders and baseline symptoms prior to school entry. In total, 1633 children (52% boys, mean ASE 6.5 years) were included. There were no relationships between ASE and parent-reported scores of the hyperactivity/inattention subscale prior to school entry and 3 months thereafter. However, at the end of first grade, ASE was negatively associated with the hyperactivity/inattention subscale in parent (− 0.7 subscale points per year ASE, standard error = 0.16, p < 0.0001) and teacher reports (− 1.2 subscale points per year ASE, standard error = 0.25, p < 0.0001). This ASE effect appeared more pronounced in girls than in boys. Young ASE is related to more reported symptoms of ADH at the end of first grade, but not before. The evolvement of this effect during first grade may be a clue to ASE-related stress factors. [ABSTRACT FROM AUTHOR]

Published
2022
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36. No benefit of a pediatric screening in discovering reduced visual acuity in children: Experiences from a cross-sectional study in Germany

Author

Elflein, Heike, Pokora, Roman, Müller, Denis F., Jahn, Klaus, Ponto, Katharina, Pitz, Susanne, Pfeiffer, Norbert, Schuster, Alexander K., Urschitz, Michael Siegfried, Elflein, Heike, Pokora, Roman, Müller, Denis F., Jahn, Klaus, Ponto, Katharina, Pitz, Susanne, Pfeiffer, Norbert, Schuster, Alexander K., and Urschitz, Michael Siegfried

Abstract

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.

Published
2020

39. Wie gut sehen unsere ABC-Schützen?

Author

Elflein, Heike M., primary, Pokora, Roman, additional, Müller, Denis, additional, Schuster, Alexander K., additional, Jahn, Klaus, additional, Ponto, Katharina A., additional, Pitz, Susanne, additional, Pfeiffer, Norbert, additional, and Urschitz, Michael S., additional

Published
2020
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41. The Prevalence of Visual Impairment in the Adult Population: Insights From the Gutenberg Health Study

Author

Wolfram, Christian, K. Schuster, Alexander, M. Elflein, Heike, Nickels, Stefan, Schulz, Andreas, S. Wild, Philipp, E. Beutel, Manfred, Blettner, Maria, Münzel, Thomas, J. Lackner, Karl, and Pfeiffer, Norbert

Subjects
Adult, Male, genetic structures, Middle Aged, Blindness, eye diseases, Cohort Studies, Age Distribution, Cross-Sectional Studies, Germany, Prevalence, Humans, Original Article, Female, Sex Distribution, Aged
Abstract

BACKGROUND: The distribution of visual impairment is an indicator of the health status of the population and for the frequency of diseases of the eye. METHODS: The Gutenberg Health Study (GHS) is a population-based cohort study in Germany concerning adults aged 35 to 74. 15 010 subjects from the Mainz–Bingen region underwent general medical and ophthalmological examination, with measurement of the distance-corrected visual acuity in each eye separately. As per the World Health Organization criteria, visual impairment was defined as an acuity below 0.3 in the better eye, and blindness as an acuity below 0.05. All patients who were found to be visually impaired or blind underwent further individual study with clinical history-taking, split-lamp examination, and fundus photography. RESULTS: Data from 14 687 subjects were evaluated. The mean age of the participants was 55.0 years (standard deviation, 11.1 years). The prevalence of visual impairment was 0.37% (95% confidence interval [0.28; 0.49]) (n = 55) and was higher in women (0.44%) than in men (0.31%). Blindness was present in 0.05% [0.03; 0.11] (n = 8) of the subjects. The prevalence of visual impairment from age 65 onward was 0.79%, three times higher than in the younger age groups. 54.5% of the visually impaired subjects had multiple underlying ophthalmological pathologies. CONCLUSION: The causes of visual impairment are manifold. Loss of vision is often the combined effect of multiple pathological factors. The etiology of visual impairment is thus a more complex matter than is commonly assumed.

Published
2019

42. Additional file 6: of Health-related quality of life and mental health in children and adolescents with strabismus – results of the representative population-based survey KiGGS

Author

Schuster, Alexander, Elflein, Heike, Pokora, Roman, Schlaud, Martin, Baumgarten, Franz, and Urschitz, Michael

Abstract

Table S6. Parental-report of health-related quality of life scores stratified by the presence/absence of strabismus (age 11–17 years). Data from the KiGGS Study 2003–2006. (DOCX 15 kb)

Published
2019
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43. Additional file 7: of Vision-related quality of life considering both eyes: results from the German population-based Gutenberg Health Study (GHS)

Author

Nickels, Stefan, Schuster, Alexander, Elflein, Heike, Wolfram, Christian, Schulz, Andreas, Münzel, Thomas, Beutel, Manfred, Schmidtmann, Irene, Finger, Robert, and Pfeiffer, Norbert

Abstract

Table S4b. Linear regression estimates of the influence of both the better-seeing and worse-seeing eyes on the NEI VFQ-25 socioemotional scale score in the German population-based Gutenberg Health Study (GHS), 2007–2012, restricted to participants aged 65 years and older. (PDF 215 kb)

Published
2019
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45. Additional file 1: of Health-related quality of life and mental health in children and adolescents with strabismus – results of the representative population-based survey KiGGS

Author

Schuster, Alexander, Elflein, Heike, Pokora, Roman, Schlaud, Martin, Baumgarten, Franz, and Urschitz, Michael

Abstract

Table S1.Cronbach’s alpha of parent-reported health-related quality of life scores (N = 12,989). Data from the KiGGS Study 2003–2006. (DOCX 15 kb)

Published
2019
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46. Additional file 4: of Vision-related quality of life considering both eyes: results from the German population-based Gutenberg Health Study (GHS)

Author

Nickels, Stefan, Schuster, Alexander, Elflein, Heike, Wolfram, Christian, Schulz, Andreas, Münzel, Thomas, Beutel, Manfred, Schmidtmann, Irene, Finger, Robert, and Pfeiffer, Norbert

Abstract

Table S3a. Linear regression estimates of the influence of both the better-seeing and worse-seeing eyes on the NEI VFQ-25 visual functioning scale score in the German population-based Gutenberg Health Study (GHS), 2007–2012, restricted to participants aged younger than 65 years. (PDF 215 kb)

Published
2019
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48. Additional file 6: of Vision-related quality of life considering both eyes: results from the German population-based Gutenberg Health Study (GHS)

Author

Nickels, Stefan, Schuster, Alexander, Elflein, Heike, Wolfram, Christian, Schulz, Andreas, Münzel, Thomas, Beutel, Manfred, Schmidtmann, Irene, Finger, Robert, and Pfeiffer, Norbert

Abstract

Table S4a. Linear regression estimates of the influence of both the better-seeing and worse-seeing eye on the NEI VFQ-25 socioemotional scale score in the German population-based Gutenberg Health Study (GHS), 2007–2012, restricted to participants aged younger than 65 years. (PDF 215 kb)

Published
2019
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49. Additional file 2: of Health-related quality of life and mental health in children and adolescents with strabismus – results of the representative population-based survey KiGGS

Author

Schuster, Alexander, Elflein, Heike, Pokora, Roman, Schlaud, Martin, Baumgarten, Franz, and Urschitz, Michael

Abstract

Table S2. Cronbach’s alpha of self-reported health-related quality of life scores (N = 12,989). Data from the KiGGS Study 2003–2006. (DOCX 15 kb)

Published
2019
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