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17. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: Subgroup analysis of the MEAD study

Author

Augustin, A. J., Kuppermann, B. D., Lanzetta, P., Loewenstein, A., X. -Y., Li, Cui, H., Hashad, Y., Whitcup, S. M., Abujamra, S., Acton, J., Ali, F., Antoszyk, A., Awh, C. C., Barak, A., Bartz-Schmidt, K. U., Baumal, C. R., Belfort, R. Jr., Bhende, M., Boyer, D. S., Bridges, W. Z. Jr., Brown, D. M., Carmichael, T., Carnevale, K., Casella, A. M., Chang, T., Chechik, D., Chen, S. -N., Chong, L. P., Chong, V., Corwin, J., Creuzot-Garcher, C., Cruess, A., Daniell, M., De Avila, M. P., De Moraes, H. V. Jr., Devenyi, R. G., Doft, B. H., Donaldson, M., Dreyer, R., Eliott, D., Engel, H. M., Ernest, J., Essman, T. F., Falcone, P. M., Fekrat, S., Ferencz, J. R., Ferreira, J. L., Figueira, J., Fiser, I., Foster, B., Fox, G. M., Freeman, W. R., Garg, S. P., Gillies, M., Glaser, D., Goldstein, B. G., Gomes, A. M. V., Gonder, J. R., Gopal, L., Gous, P., Gupta, A., Halperin, L., Han, D., Hariprasad, S. M., Holz, F. G., Kaiser, P., Kalvodova, B., Katz, B., Katz, R. S., Kecik, D., Kellaway, J., Klemperer, I., Lattanzio, R., Lee, W. -K., Lehr, J., Leys, M., Loose, I., Lotery, A., D. -W., Lu, Mccartney, P., Majji, A. B., Martinez, J. A., Massin, P., Maturi, R. K., Menchini, U., Menon, G., Michels, M., Midena, E., Miller, J. Jr., Mitchell, P., Moisseiev, J., Morse, L., Navarro, R., Nemeth, J., Newland, H., Newsom, R., Nichols, J., Orellana, J., Orzalesi, N., Paranhos, A. Jr., Park, R., Park, S., Parodi, M. B., Pavan, P. R., Peace, J., Perez-Ortiz, D. J., Pollack, A., Ramaswamy, K., Ratnakaram, R., Ravalico, G., Rehak, J., Rezaei, K., Rizzo, S., Rodriguez-Alvira, F. J., Romanet, J. -P., Rose, S., Rosen, R. B., Rossetti, L., Ruiz-Moreno, J. M., Sadda, S., Sall, K., Sandner, D., Sanz, A. F. -V., Sartani, G., Schmickler, S., Schwartz, S. D., Sharma, Y. R., Sheu, S. -J., Singer, M., Sivaprasad, S., Soubrane, G., Soucek, P., Souied, E. H., Staurenghi, G., Studnicka, J., Suarez-Figueroa, M., Takahashi, W. Y., Tognetto, D., Tsai, P. L., Ulanski, L. J., H. S., Uy, Varano, M., Veith, M., Vicha, I., Viola, F., Visser, L., Weinberger, D., Wing, G. L., Wong, E., Wong, T. Y., Wylegala, E., Yan, J., Yoon, Y. H., Young, L. H., H. G., Yu, Zimmer-Galler, I. E., Augustin, Aj, Kuppermann, Bd, Lanzetta, P, Loewenstein, A, Li, Xy, Cui, H, Hashad, Y, Whitcup, Sm, on behalf of for the Ozurdex MEAD Study, Group, Battaglia Parodi, M, Augustin, A. J., Kuppermann, B. D., Lanzetta, P., Loewenstein, A., Li, X. -Y., Cui, H., Hashad, Y., Whitcup, S. M., Abujamra, S., Acton, J., Ali, F., Antoszyk, A., Awh, C. C., Barak, A., Bartz-Schmidt, K. U., Baumal, C. R., Belfort, R., Bhende, M., Boyer, D. S., Bridges, W. Z., Brown, D. M., Carmichael, T., Carnevale, K., Casella, A. M., Chang, T., Chechik, D., Chen, S. -N., Chong, L. P., Chong, V., Corwin, J., Creuzot-Garcher, C., Cruess, A., Daniell, M., De Avila, M. P., De Moraes, H. V., Devenyi, R. G., Doft, B. H., Donaldson, M., Dreyer, R., Eliott, D., Engel, H. M., Ernest, J., Essman, T. F., Falcone, P. M., Fekrat, S., Ferencz, J. R., Ferreira, J. L., Figueira, J., Fiser, I., Foster, B., Fox, G. M., Freeman, W. R., Garg, S. P., Gillies, M., Glaser, D., Goldstein, B. G., Gomes, A. M. V., Gonder, J. R., Gopal, L., Gous, P., Gupta, A., Halperin, L., Han, D., Hariprasad, S. M., Holz, F. G., Kaiser, P., Kalvodova, B., Katz, B., Katz, R. S., Kecik, D., Kellaway, J., Klemperer, I., Lattanzio, R., Lee, W. -K., Lehr, J., Leys, M., Loose, I., Lotery, A., Lu, D. -W., Mccartney, P., Majji, A. B., Martinez, J. A., Massin, P., Maturi, R. K., Menchini, U., Menon, G., Michels, M., Midena, E., Miller, J., Mitchell, P., Moisseiev, J., Morse, L., Navarro, R., Nemeth, J., Newland, H., Newsom, R., Nichols, J., Orellana, J., Orzalesi, N., Paranhos, A., Park, R., Park, S., Parodi, M. B., Pavan, P. R., Peace, J., Perez-Ortiz, D. J., Pollack, A., Ramaswamy, K., Ratnakaram, R., Ravalico, G., Rehak, J., Rezaei, K., Rizzo, S., Rodriguez-Alvira, F. J., Romanet, J. -P., Rose, S., Rosen, R. B., Rossetti, L., Ruiz-Moreno, J. M., Sadda, S., Sall, K., Sandner, D., Sanz, A. F. -V., Sartani, G., Schmickler, S., Schwartz, S. D., Sharma, Y. R., Sheu, S. -J., Singer, M., Sivaprasad, S., Soubrane, G., Soucek, P., Souied, E. H., Staurenghi, G., Studnicka, J., Suarez-Figueroa, M., Takahashi, W. Y., Tognetto, D., Tsai, P. L., Ulanski, L. J., Uy, H. S., Varano, M., Veith, M., Vicha, I., Viola, F., Visser, L., Weinberger, D., Wing, G. L., Wong, E., Wong, T. Y., Wylegala, E., Yan, J., Yoon, Y. H., Young, L. H., Yu, H. G., and Zimmer-Galler, I. E.

Subjects
Male, Vascular Endothelial Growth Factor A, Visual acuity, Triamcinolone acetonide, genetic structures, medicine.medical_treatment, Visual Acuity, Angiogenesis Inhibitors, Drug Implant, Triamcinolone Acetonide, Dexamethasone, Immunosuppressive Agent, Glucocorticoid, Diabetic retinopathy, Dexamethasone Intravitreal Implant, Corticosteroid, Drug delivery, Implant, Macular edema, Aged, Diabetic Retinopathy, Drug Implants, Female, Glucocorticoids, Humans, Immunosuppressive Agents, Intravitreal Injections, Macular Edema, Middle Aged, Retreatment, Tomography, Optical Coherence, Ophthalmology, Tomography, General Medicine, medicine.symptom, medicine.drug, Angiogenesis Inhibitor, Human, Research Article, medicine.medical_specialty, Subgroup analysis, medicine, business.industry, Intravitreal Injection, Cataract surgery, medicine.disease, eye diseases, Optical Coherence, business
Abstract

Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34–68 Early Treatment Diabetic Retinopathy Study letters (20/200–20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was −126.1 μm with DEX 0.7 versus −39.0 μm with sham (P

Published
2015

18. The biometric study in different stages of primary angle-closure glaucoma

Author

Chen, Y-Y, Sheu, S-J, and Chou, P

Subjects
Male, medicine.medical_specialty, Intraocular pressure, Biometry, Visual acuity, Anterior Chamber, Glaucoma, Cup-to-disc ratio, Primary angle-closure glaucoma, Sex Factors, Risk Factors, Ophthalmology, Lens, Crystalline, medicine, Humans, Aged, business.industry, Age Factors, Odds ratio, Axial length, Middle Aged, medicine.disease, humanities, Axial Length, Eye, Blood pressure, Clinical Study, Disease Progression, Female, medicine.symptom, Epidemiologic Methods, Glaucoma, Angle-Closure, business
Abstract

This study compared the general and ocular biometric characteristics of normal, primary angle closure (PAC), and primary angle-closure glaucoma (PACG) patients to better understand the possible relationship between differences in ocular parameters that might predict risk for PACG in PAC patients. One hundred normal, 90 PAC, and 90 PACG eyes were retrospectively reviewed. General characteristics such as age, gender, body height, body weight, blood pressure, pulse, systemic diseases, and education level were recorded. Ocular findings included visual acuity, intraocular pressure, refraction, cup to disc ratio, and ocular biometry. Ocular biometry was obtained by A-scan ultrasonography (Digital A/B scan 5500; Sonomed Inc., Lake Success, NY, USA). The parameters recorded were anterior chamber depth (ACD), lens thickness (LT), axial length (AXL), lens/axial length factor (LAF), and relative lens position (RLP). Although the controls, PAC group, and PACG group were found to be significantly different in age (62.7±9.8; 65.3±7.5; and 66.0±7.4, respectively), there were no gender differences. With regard to ocular parameters, the ACD tended to decrease and the LT and LAF tended to increase from normal to PAC to PACG. The eyes of the PACG group had significantly shallower ACD (P

Published
2013

32. A remark on the large deviations of an ergodic markov process

Author

Fleming, W. H., Sheu, S. J., and Soner, H. M.

Abstract

We give an alternative proof of the Donsker-Varadhan result for the large time behavior of the occupation measure of a Feller-Markov process µt, taking values in a compact metric space X. For any Weak* continuous functions φ(μ) on the space of probability measures on X, we identify [image omitted] through a linearization argument.

Published
1987
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48. [The existential phenomenology of family care of psychiatric patients].

Author

Sheu SJ, Tseng CI, and Tsui HY

Subjects
Existentialism, Humans, Caregivers psychology, Family psychology, Mental Disorders nursing
Abstract

This study utilizes the perspectives of phenomenological approach and existential analysis to understand the common meaning and existential status of care through the description of care-giving and care-receiving experiences by both psychiatric patients and their families. Multiple perspectives and methods were used for data cellection, including participant observation and individual and group interviews. Five themes emerged from the hermeneutic data analysis which represent the existential status and types of family care for psychiatric patients: (1) Taken-for-granted care; (2) Nonexistent care; (3) Limited care; (4) Replacemental or transcendental care; (5) Displacemental or exchangeable care. Following the results, several issues are discussed. First, the existential meaning and values of family caregiving for psychiatric patients are explored. Subsequently, indigenous psychiatric mental health care problems in Taiwan are discussed. Finally, health professionals need to pay attention to the mutual existential caring status from self and others as well as the transcendental and exchangeable relationships from both the care-givers' and the care-receivers' perspectives.

Published
2001

49. Histopathology of polytetrafluoroethylene (Gore-tex) as a scleral buckle in humans.

Author

Sheu SJ, Chou LC, Lee IY, and Wang CC

Subjects
Fibrosis, Granuloma, Foreign-Body etiology, Humans, Male, Middle Aged, Oculomotor Muscles pathology, Reoperation, Sclera pathology, Scleral Buckling instrumentation, Scleral Buckling methods, Tissue Adhesions, Vitrectomy, Granuloma, Foreign-Body pathology, Polytetrafluoroethylene adverse effects, Retinal Detachment surgery, Scleral Buckling adverse effects
Abstract

Several materials have been used for scleral buckling implants in retinal detachment surgery. Of these, polytetrafluoroethylene (PTFE, Gore-tex) has the relative advantage of decreasing infection and extrusion when it is used as a scleral buckle material. In this report, we present the clinical and histopathologic finding of a case where Gore-tex was used as an encircling buckle material for retinal detachment operation.

Published
2001

50. Should asymptomatic atrophic retinal holes be treated prophylactically in pseudophakic eyes after Nd:YAG laser posterior capsulotomy?

Author

Sheu SJ, Lee YC, Chen CJ, and Wu TT

Subjects
Adult, Aged, Female, Humans, Male, Middle Aged, Retrospective Studies, Cataract Extraction adverse effects, Laser Therapy adverse effects, Pseudophakia etiology, Retinal Detachment etiology, Retinal Perforations therapy
Abstract

Background: Retinal detachment (RD) following cataract extraction is a serious and potentially sight-threatening event that will often necessitate further surgical intervention. Of the several risk factors reported in the literature, Neodymium:YAG laser posterior capsulotomy has been reported to increase the risk of RD following cataract surgery up to 4.9-fold. The purpose of this study is to investigate the difference of characteristics in pseudophakic RD with or without Nd:YAG laser posterior capsulotomy and the possible role of atrophic retinal holes in pseudophakic RD after posterior capsulotomy., Methods: Retrospective review of 78 cases of pseudophakic RD after uncomplicated extracapsular lens extraction and intraocular lens implantation was done. Twenty-one of them received Nd:YAG laser posterior capsulotomy before RD. We measured the numbers, types, and locations of retinal breaks and several other risk factors associated with RD. Analysis was performed with the system of Statistical Products and Services Solutions (SPSS)., Results: The ratio of retinal holes only in retinal breaks that caused retinal detachment was significantly higher in the capsulotomy group than the non-capsulotomy group (12/21 vs 14/57, p = 0.05). Only three patients in the capsulotomy group claimed significant symptoms before the detachment. There was no significant difference in mean number of retinal breaks and break location. Other risk factors predisposing to RD did not differ significantly between the two groups (13/21 vs 23/57, p = 0.12), nor did the interval from cataract surgery to RD (31.20 vs 29.44 months, p = 0.48)., Conclusions: This primitive study suggests that asymptomatic atrophic retinal holes, usually not regarded as an absolute risk factor for RD, might lead to RD preferentially after Nd:YAG laser posterior capsulotomy. Early identification and treatment of such breaks might decrease the incidence of pseudophakic RD. We suggest that it is necessary to perform detailed preoperative and postoperative fundus examination and treat prophylactically any identified breaks, including asymptomatic atrophic retinal holes, in pseudophakic eyes after Nd:YAG laser posterior capsulotomy.

Published
2001

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