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1. Integrated results from the COPERNICUS and GALILEO studies

Author

Pielen A, Clark WL, Boyer DS, Ogura Y, Holz FG, Korobelnik JF, Stemper B, Asmus F, Rittenhouse KD, Ahlers C, Vitti R, Saroj N, Zeitz O, and Haller JA

Subjects
macular edema, central retinal vein occlusion, anti-vascular endothelial growth factor, aflibercept, COPERNICUS, GALILEO, Ophthalmology, RE1-994
Abstract

Amelie Pielen,1,2 W Lloyd Clark,3 David S Boyer,4 Yuichiro Ogura,5 Frank G Holz,6 Jean-Francois Korobelnik,7,8 Brigitte Stemper,9,10 Friedrich Asmus,9 Kay D Rittenhouse,11 Christiane Ahlers,9 Robert Vitti,12 Namrata Saroj,12 Oliver Zeitz,9,13,14 Julia A Haller15 On behalf of the COPERNICUS and GALILEO study group 1Eye Center, University Hospital Freiburg, Eye Hospital, Freiburg, 2Hannover Medical School, University Eye Hospital, Hannover, Germany; 3Palmetto Retina Center, Columbia, SC, USA; 4Retina-Vitreous Associates Medical Group, Beverly Hills, CA, USA; 5Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 6Department of Ophthalmology, University of Bonn, Bonn, Germany; 7Service d’ophtalmologie, CHU de Bordeaux, 8Service d’ophtalmologie, University of Bordeaux, Inserm, Bordeaux Population Health Research Center, Team LEHA, UMR 1219, Bordeaux, France; 9Bayer AG, Berlin, 10Department of Neurology, University of Erlangen-Nuremberg, Erlangen, Germany; 11Bayer US LLC, Whippany, NJ, 12Regeneron Pharmaceuticals, Tarrytown, NY, USA; 13AKH Eye Clinic, Braunschweig, 14Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Augenheilkunde, Hamburg, Germany; 15Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA Objectives: To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients and methods: Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. Results: At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in

Published
2017

2. ONSET AND DURATION OF VISUAL ACUITY IMPROVEMENT AFTER DEXAMETHASONE INTRAVITREAL IMPLANT IN EYES WITH MACULAR EDEMA DUE TO RETINAL VEIN OCCLUSION

Author

Kuppermann BD, Haller JA, Loewenstein A, Jiao J, Li XY, Whitcup SM, BANDELLO , FRANCESCO, Kuppermann, Bd, Haller, Ja, Bandello, Francesco, Loewenstein, A, Jiao, J, Li, Xy, and Whitcup, Sm

Abstract

Purpose: To evaluate the onset and duration of improvement in best-corrected visual acuity (BCVA) in eyes treated with dexamethasone intravitreal implant 0.7 mg (DEX implant) for macular edema after branch or central retinal vein occlusion. Methods: Post hoc analysis of data from 2 previously reported multicenter, 6-month, randomized sham-controlled clinical trials. Patients received a single DEX implant (n = 427) or sham procedure (n = 426) in the study eye. The primary endpoint was the percentage of eyes with >= 15-letter improvement in BCVA from baseline at postimplant Day 7. Results: The baseline mean BCVA was 20/80. At Day 7, 10.3% of DEX implant-treated eyes versus 4.0% of sham-treated eyes (P < 0.001) had >= 15-letter improvement in the BCVA, and 27.2% of DEX implant-treated eyes versus 10.6% of sham-treated eyes had >= 10-letter improvement (P < 0.001). The mean improvement at Day 7 was 5.3 letters (branch retinal vein occlusion, 5.1; and central retinal vein occlusion, 5.8) with DEX implant and 1.6 letters (branch retinal vein occlusion, 2.3; and central retinal vein occlusion, 0.1) with sham (P < 0.001). The mean time from initial observation of >= 15-letter BCVA gain to the last observation of >= 15-letter BCVA gain was 70 days. Conclusion: Dexamethasone intravitreal implant treatment led to improvement in BCVA compared with sham procedure as early as postimplant Day 7. The duration of >= 3-line improvement was typically 2 to 3 months.

Published
2014

3. Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind

Author

Ho, AC, Humayun, MS, Dorn, JD, da Cruz, L, Dagnelie, G, Handa, J, Barale, PO, Sahel, JA, Stanga, PE, Hafezi, F, Safran, AB, Salzmann, J, Santos, A, Birch, D, Spencer, R, Cideciyan, AV, de Juan, E, Duncan, JL, Eliott, D, Fawzi, A, Olmos de Koo, LC, Brown, GC, Haller, JA, Regillo, CD, Del Priore, LV, Arditi, A, Geruschat, DR, and Greenberg, RJ

Subjects
genetic structures, eye diseases
Abstract

© 2015 American Academy of Ophthalmology. Purpose: Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation. Design: The study is a multicenter, single-arm, prospective clinical trial. Participants: There were 30 subjects in 10 centers in the United States and Europe. Subjects served as their own controls, that is, implanted eye versus fellow eye, and system on versus system off (native residual vision). Methods: The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. Main Outcome Measures: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Results: A total of 29 of 30 subjects had functioning Argus II Systems implants 3 years after implantation. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the system on than off on all visual function tests and functional vision assessments. Conclusions: The 3-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the Food and Drug Administration and a CE mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.

Published
2015
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4. Intravitreal Injection Technique Reply

Author

Haller JA, Belfort R, Gillies M, Loewenstein A, Yoon YH, Li XY, Whitcup SM, BANDELLO , FRANCESCO, Haller, Ja, Bandello, Francesco, Belfort, R, Gillies, M, Loewenstein, A, Yoon, Yh, Li, Xy, and Whitcup, Sm

Published
2012

5. Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion

Author

Haller, Ja, Bandello, F, Belfort R., Jr, Blumenkranz, M. S., Gillies, M, Heier, J, Loewenstein, A, Yoon, Yh, Jiao, J, Li, Xy, Whitcup, S. M., Aaberg, Tm, Abraham, P, Abujamra, S, Acton, J, Adamczyk Ludyga, A, Adenwalla, M, Agahigian, Dd, Agoas, V, Aguilar Mendoza, M, Aisenbrey, S, Alam, S, Albiani, D, Alexandrescu, B, Alfaiate, Mm, Allam, S, Almeida, Hp, Anagnoste, S, Anand, R, Anderson, N, Antoszyk, A, Armogan, N, Arnold, J, Ash, D, Atlas, Wg, Augustin, Ja, de Ávila MP, Awh, C, Azzolini, C, Babkova, B, Bakri, Sj, Banach, Mj, Barak, A, Barile, G, Barker, D, Barnard, T, Bartz Schmidt KU, Battaglia Parodi, M, Baumal, C, Bedrich, P, Beer, P, Belfort Mattos Junior, R, Bellini, L, Benner, J, Benson, W, Benz, M, Berger, B, Bergren, R, Bharadwaj, A, Bhavan, S, Bhavsar, A, Binder, S, Biondi, A, Bishop, F, Blair, N, Blinder, K, Blumenkranz, M, Bohm, A, Boldrey, Ee, Bornfeld, N, Borrillo, Jl, Boyer, D, Bradford, R, Bridges, W, Brigatti, L, Briggs, M, Brooks HL Jr, Brown, D, Browning, A, Browning, D, Brunner, S, Brunnerova, R, Bryan, Js, Brydak Godowska, J, Buettner, H, Burns, J, Burrows, Af, Busbee, B, Butner, R, Butter, J, Byrnes, G, Callahan, C, Campochiaro, P, Cano Hildalgo RA, Canziani, T, Capaccioli, K, Capone, A, Carmichael, T, Carnevale, K, Casella, Am, Casey, R, Castanheira Dinis, A, Celis, B, Chambers, R, Chang, S, Chang, Yh, Chechik, D, Chee, Sp, Chen, E, Chen, Jt, Chen, Sn, Chen, S, Cheng, B, Chiquet, C, Chong, K, Chong, Lp, Chong, V, Chou, T, Chow, V, Chrapek, O, Chu, T, Chua, J, Chun, D, Chung, Hw, Cialdini, Ap, Ciancas, E, Cihelkova, I, Cisiecki, S, Clark, W, Cleary, T, Coco, R, Codenotti, M, Cohen, Bz, Cohen, Ja, Cohen, J, Connolly, B, Conway, B, Cook, H, Cooper, B, Coors, L, Corwin, J, Costa, Jr, Cottrell, D, Couvillion, S, Craig, J, Cruess, A, Dabbs, T, Danesh, S, Davidorf, F, Davis, J, De Cilla, S, De Fazio, R, de la Fuente MA, de la Rua ER, De Mattia, M, Deen, A, Del Priore, L, Delyfer, Mn, Deuter, C, Devadason, Ds, Devenyi, R, D'Heurle, D, Dickinson, J, Doft, B, Dooner, J, Doubell, D, Downie, J, Drenser, K, Dreyer, R, D'Sousa, Y, Du, T, Duarte, L, Dubiner, Hb, Dubovy, S, Dubska, Z, Dugel, P, Dunn, W, Dusova, J, Dvorak, J, Dyer, D, Dziegielewska, K, Earl, M, Egan, C, Eichenbaum, D, Eifrig, C, Ells, A, El Shabrawi, Y, Elsherbiny, S, Engel, H, Engelbrecht, N, Ernest, J, Essex, R, Eter, N, Evans, R, Fakadej, A, Falcone, P, Fan, D, Fan, Jt, Eid Farah, M, Farah, S, Feiner, L, Feldman, Rm, Ferencz, J, Fernandez Vega Sanz, A, Ferreira, Jl, Figueira, J, Fineman, M, Fiser, I, Fish, G, Fish, Rh, Fishburne, B, Fisher, Sj, Fitzsimons, R, Flaxel, C, Fletcher, E, Flores Aguilar, M, Florez, S, Flynn, H, Fogarty, S, Folgado, A, Foster, Bs, Fox, Gm, Frambach, D, Framme, C, Fransen, S, Fraser Bell, S, Frederick, A, Freeman, W, Freisberg, L, Friedman, E, Friedman, L, Fucik, M, Fuller, Dg, Gaitan, J, Gallemore, R, Gallogly, P, Arumi, Jg, Garg, S, Garretson, B, Gastaud, P, Gaudric, A, Gawrilow, P, Gehlbach, Pl, Geyer, O, Ghuman, At, Giansanti, F, Luiz Gil, A, Gilbert, Hd, Girmens, Jf, Giubilato, A, Glacet Bernard, A, Glaser, D, Glatzer, R, Goldstein, D, Gomes, Am, Gon Yu, H, Gonçalves, Fp, Gonzales, C, Googe, J, Gopal, L, Gordon, A, Gous, P, Grand, M, Cristina, P, Magro, G, Granero Riano, M, Grassi, M, Green, J, Green, S, Gregor, Z, Gregori, N, Grizzard, Ws, Groenewald, C, Gross, Jg, Gross, Ne, Gruber, A, Grutow, G, Guillet, E, Gupta, A, Gyorgyova, D, Haas, A, Haas, K, Hadden, P, Hagemann, L, Hainsworth, D, Haivala, D, Haller, J, Halperin, L, Hamer, P, Hammer, M, Han, D, Handa, Jt, Handelman, I, Handza, J, Harder, B, Harding, S, Hariprasad, Sm, Hartley, K, Hartman, P, Hartnett, Me, Harvey, P, Hassan, T, Headon, M, Hejsek, L, Higgins, P, Hillenkamp, J, Ho, A, Ho, T, Holekamp, N, Holz, E, Holz, F, Hooper, P, Hopkins, Jj, Hoskin Mott, A, Hoskins, J, Hrisomalos, N, Hsu, J, 3rd, Hubbard B., Hudson, H, Hughes, E, Hunt, A, Hunyor, A, Hwang, T, Hwang, Jf, Ibarra, M, Incarnato, N, Inhetvin Hutter, C, Introini, U, Isaacs, T, Islam, N, Iyer, Mn, Jablonski, C, Jack, Rl, Jager, R, Jahn, C, Jao, C, Jehan, F, Jonas, J, Joseph, D, Joshi, M, Jost, B, Jurklies, B, Kaincova, I, Kaiser, P, Kaiser, R, Kalvodova, B, Kamppeter, B, Kanann, Nb, Kang, K, Katz, Rs, Kaushal, S, Kecik, D, Kellaway, J, Kelly, K, Kelly, S, Khan, J, Kherani, A, Kim, R, Kim, I, Kim, J, Kim, Jg, Kim, N, Kim, Tw, Kingsley, R, Klein, R, Klemperer, I, Kociecki, J, Korbasova, M, Korda, V, Korobelnik, Jf, Koshy, Z, Kostamaa, H, Kovach, J, Kozak, I, Kozousek, V, Krasny, J, Kreiger, A, Krivosic, V, Krug JV Jr, Kruger, L, Kunimoto, D, Kuppermann, Bd, Kurtz, R, Kuznik Borkowska, A, Lai, J, Lai, W, Lake, S, Lalwani, G, Lam, Wc, Lanning, Rc, Lanzetta, Paolo, Lara, W, Larrison, Wi, Lattanzio, R, Lavina, A, Lavinsky, J, Lazzaroni, F, Lee, E, Yong Lee, J, Lee, M, Young Lee, S, Lee, V, Leff, S, Lehr, J, Lenfesty, P, Leonard, R, Levine, A, Levitan, M, Lewis, H, Liew, S, Lim, J, Lim, R, Lin, R, Lip, Pl, Liu, J, Lobes, La, Loose, I, Lotery, A, Lottenberg, Cl, Loutchkina, D, Lu, Dw, Lubczynska, A, Lujan, B, Lyssek Boron, A, Ma, C, Ma, P, Maberley, D, Maccumber, M, Madhusudhana, Kc, Madreperla, S, Magee, M, Magolan, J, Maia Junior Ode, O, Maia, A, Majji, A, Malthieu, D, Mango, C, Marmor, M, Marques, L, Martin, D, Martinez, Ja, Massaoutis, P, Mathai, A, Mathur, R, Mattioli, S, Maturi, Rk, Mazur Michalek, I, Mcallister, I, Mccabe, F, Mccannel, Ca, Mcgimpsey, S, Mchugh, Jd, Mckibbin, M, McLean WC Jr, Mcmillan, T, Meireles, R, de Melo CS, Menchini, U, Meredith, T, Merrill, P, Mian, U, Michels, M, Midena, E, Mieler, Wf, Migliavacca, L, Miller, D, Miller, J, Mincey, G, Mitchell, P, Katsuki Mizubuti, S, Mohamed, S, Mohammed, M, Moinfar, N, Moisseiev, J, Mones, J, Montemayor Lobo, R, Montero, J, de Moraes NI, Moreira CA Jr, Morely, M, Moreno, Jm, Moron, Jt, Morrison, Vl, Morse, L, Moshfeghi, A, Moshfeghi, D, Muccioli, C, Munshi, V, Murthy, Rc, Naing, T, Nair, R, Nascimento, J, Nascimento, Vp, Nawrocka, Z, Nawrocki, J, Newell, C, Newsom, R, Nguyen, J, Nguyen, Q, Nguyen, Rl, Nichols, J, Nilanjana, D, Noguchi, B, Noorily, S, Novack, R, Novak, M, Novalis, G, O'Brien, D, Offermann, I, Oguido, Ap, Oh, K, Okruszko, A, de Oliveira TL, Oliver, S, Ong, S, Orellana, J, Orzalesi, N, O'Toole, L, Ovando, Y, Paccione, J, Pach, J, Packo, K, Packowska, Ma, Palmer, J, Palmer, H, Palombi, K, Papp, A, Paques, M, Paranhos A., Jr, Park, D, Park, Ri, Park, S, Parke, D, Parravano, M, Pastor Jimeno JC, Patel, S, Patra, S, Pavan, Pr, Pearce, I, Pecold, K, Pedio, M, Peh, Kk, Pelosini, L, Pendergast, S, Perez, Br, Perez Ortiz DJ, Perkins, S, Peters, M, Pheasant, T, Pilat, J, Pilotto, E, Piltz Seymour, J, Pirracchio, A, Pollack, A, Portella, E, Pracharova, Z, Prati, M, Prensky, Jg, Preston, R, Prieto, F, Puls, S, Purohit, Ar, Quintao, T, Rahhal, F, Rahman, W, Ramos, Ar, Ramsey, S, Rani, A, Rao, Pk, Rapizzi, E, Raskauskas, P, Ratiglia, R, Ratnakaram, R, Rauser, Me, Regillo, C, Rehak, J, Reichel, E, Reid, Da, Rejmont, L, Rougier, Mb, Ribon, Ri, Ricarova, R, Rich, R, Riley, A, Ripandelli, G, Rishi, E, Rivett, K, Rogers, A, Romanet, Jp, Rosa, Pj, Rosberger, D, Rose, S, Rosenfeld, P, Ross, Rr, Rotberg, M, Roth, Cb, Roth, D, Rubaltelli, D, Rubsamen, P, Ruby, A, Ruiz Moreno JM, Ruiz, R, Russell Gonder, J, Russell, M, Ryu, Jw, Sachs, H, Sadda, S, Safar, A, Salinas, C, Sall, K, Samad, A, Samkova, K, Sanders, J, Sandhu, R, Sandhu, Ss, Sandner, D, Sanislo, Sr, Sartani, G, Saviano, S, Savy, O, Schechter, Ba, Schenker, Hi, Schiff, W, Schlichtenbrede, F, Schneider, B, Schneider, L, Schneiderman, T, Schocket, L, Schoenherr, U, Schoenleber, D, Scholl, Hp, Schreiber, J, Schwartz, Sd, Sears, J, Sedlakova, J, Seery, C, Sell, C, Shah, G, Shapiro, M, Sharma, A, Sheidow, T, Sheu, Sj, Sheufele, T, Shukla, D, Siewec Proscinska, J, Silva, Er, Singer, M, Singer, S, Singerman, Lj, Singh, M, Siow, Yc, Sipperley, Jo, Sivaprasad, S, Sjaarda, R, Snyder, W, Sobrin, L, Sodi, A, Solomon, S, Sonkin, P, Soubrane, G, Soucek, P, Spirn, B, Srivastava, S, Stannard, K, Staurenghi, G, Steinmetz, R, Stepien, K, Stern, W, Stevenson, Od, Stewart, D, Stewart, J, Stolba, U, Stoller, G, Stone, C, Stout, Jt, Stringfellow, G, Studnicka, J, Suarez Figueroa, M, Sung, J, Susini, A, Syracuse, R, Szaflik, J, Tabandeh, H, Tadayoni, R, Takahashi, Wy, Taleb, Ac, Talks, Sj, Tamayo, L, Tan, M, Taney, B, Tarnawska, D, Tassinari, G, Taylor, J, Telander, D, Territo, C, Thomas, El, Thomas, M, Thompson, Jt, Thompson, Ws, Tiedeman, Js, Topping, T, Trese, M, Truong, S, Tsang, Cw, Tufail, A, Ufret Vincenty, R, Uhmannova, R, 2nd, Ulanski L., Ulinska, M, Urminsky, J, Uy, H, Vaishnav, H, Varano, M, Vavvas, D, Vega Sanz BF, Veloso, A, Vicha, I, Viola, F, Visser, L, Vlkova, E, Voelker, M, Volkert, D, Vossmerbaumer, U, Vu, C, Vyas, S, Wald, Kj, Walker, J, Walter, A, Wang, R, Wasiak, K, Watt, Dr, Weger, M, 3rd, Weidman F., Weinberger, D, Weisz, Jm, 3rd, Wells J., Wheatley, M, Wickremasingh, S, Wiegand, T, Wieland, M, Will, D, Williams, G, Williams, Rg, Wilson, D, Win, Ph, Wing, Gl, Wirostko, W, Wirthlin, R, Wong, Al, Wong, T, Woo, J, Wu, Tt, Wylegala, E, Yan, J, Yang, Ch, Yang, Cm, Yang, Y, Yang, Yc, Yarian, D, Yates, P, Yedavally, S, Yoken, J, Young, L, Young, S, Zago, Rj, Zakov, Z, Zaras, M, Zegarra, H, Ziemianski, M, Zimmer Galler, I, Zourdani, A, and Zur, C.

Published
2011

6. Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion

Author

Haller, Ja, Bandello, F, Belfort R., Jr, Blumenkranz, Ms, Gillies, M, Heier, J, Loewenstein, A, Yoon, Yh, Jacques, Ml, Jiao, J, Li, Xy, Whitcup, Sm, OZURDEX GENEVA Study Group, Aaberg, Tm, Abraham, P, Abujamra, S, Acton, J, Adamczyk Ludyga, A, Adenwalla, M, Agahigian, Dd, Agoas, V, Aguilar Mendoza, M, Aisenbrey, S, Alam, S, Albiani, D, Alexandrescu, B, Alfaiate, Mm, Allam, S, Almeida, Hp, Anagnoste, S, Anand, R, Anderson, N, Antoszyk, A, Armogan, N, Arnold, J, Ash, D, Atlas, Wg, Augustin, Ja, de Avila MP, Awh, C, Azzolini, C, Babkova, B, Bakri, Sj, Banach, Mj, Barak, A, Barile, G, Barker, D, Barnard, T, Bartz Schmidt KU, Parodi, Mb, Baumal, C, Bedrich, P, Beer, P, Mattos RB Jr, Bellini, L, Benner, J, Benson, W, Benz, M, Berger, B, Bergren, R, Bharadwaj, A, Bhavan, S, Bhavsar, A, Binder, S, Biondi, A, Bishop, F, Blair, N, Blinder, K, Blumenkranz, M, Bohm, A, Boldrey, Ee, Bornfeld, N, Borrillo, Jl, Boyer, D, Bradford, R, Bridges, W, Brigatti, L, Briggs, M, Brooks HL Jr, Brown, D, Browning, A, Browning, D, Brunner, S, Brunnerova, R, Renata, Js, Brydak Godowska, J, Buettner, H, Burns, J, Burrows, Af, Busbee, B, Butner, R, Butter, J, Byrnes, G, Callahan, C, Campochiaro, P, Cano Hildalgo RA, Canziani, T, Capone, A, Carmichael, T, Carnevale, K, Casella, Am, Casey, R, Castanheira Dinis, A, Celis, B, Chambers, R, Chang, S, Chang, Yh, Chechik, D, Chee, Sp, Chen, E, Chen, Jt, Chen, Sn, Chen, S, Cheng, B, Chiquet, C, Chong, K, Chong, Lp, Chong, V, Chou, T, Chow, V, Chrapek, O, Chu, T, Chua, J, Chun, D, Chung, Hw, Cialdini, Ap, Ciancas, E, Cihelkova, I, Cisiecki, S, Clark, W, Cleary, T, Coco, R, Codenotti, M, Cohen, Bz, Cohen, Ja, Cohen, J, Connolly, B, Conway, B, Cook, H, Cooper, B, Coors, L, Corwin, J, Costa, Jr, Cottrell, D, Couvillion, S, Craig, J, Cruess, A, Cupo, G, Dabbs, T, Danesh, S, Davidorf, F, Davis, J, De Cilla, S, De Fazio, R, de la Fuente MA, de la Rua ER, De Mattia, M, Deen, A, Del Priore, L, Delyfer, Mn, Deuter, C, Devadason, Ds, Devenyi, R, D'Heurle, D, Dickinson, J, Doft, B, Dooner, J, Doubell, D, Downie, J, Drenser, K, Dreyer, R, D'Sousa, Y, Du, T, Duarte, L, Dubiner, Hb, Dubovy, S, Dubska, Z, Dugel, P, Dunn, W, Dusova, J, Dvorak, J, Dyer, D, Dziegielewska, K, Earl, M, Egan, C, Eichenbaum, D, Eifrig, C, Ells, A, El Shabrawi, Y, Elsherbiny, S, Engel, H, Engelbrecht, N, Ernest, J, Essex, R, Eter, N, Evans, R, Fakadej, A, Falcone, P, Fan, D, Fan, Jt, Farah, Me, Farah, S, Feiner, L, Feldman, Rm, Ferencz, J, Fernandez Vega Sanz, A, Ferreira, Jl, Figueira, J, Fineman, M, Fiser, I, Fish, G, Fish, Rh, Fishburne, B, Fisher, Sj, Fitzsimons, R, Flaxel, C, Fletcher, E, Flores Aguilar, M, Florez, S, Flynn, H, Fogarty, S, Folgado, A, Foster, Bs, Fox, Gm, Frambach, D, Fransen, S, Fraser Bell, S, Frederick, A, Freeman, W, Freisberg, L, Friedman, E, Friedman, L, Fucik, M, Fuller, Dg, Gaitan, J, Gallemore, R, Gallogly, P, Garcia Arumi, J, Garg, S, Garretson, B, Gastaud, P, Gaudric, A, Gawrilow, P, Gehlbach, Pl, Geyer, O, Ghuman, At, Giansanti, F, Gil, Al, Gilbert, Hd, Girmens, Jf, Giubilato, A, Glacet Bernard, A, Glaser, D, Glatzer, R, Goldstein, D, Gomes, Am, Gon Yu, H, Gonçalves, Fp, Gonzales, C, Googe, J, Gopal, L, Gordon, A, Gous, P, Grand, M, Grandao Magro PC, Granero Riano, M, Grassi, M, Green, J, Green, S, Gregor, Z, Gregori, N, Grizzard, Ws, Groenewald, C, Gross, Jg, Gross, Ne, Gruber, A, Grutow, G, Guillet, E, Gyorgyova, D, Haas, A, Haas, K, Hadden, P, Hagemann, L, Hainsworth, D, Haivala, D, Haller, J, Halperin, L, Hamer, P, Hammer, M, Han, D, Handa, Jt, Handelman, I, Handza, J, Harder, B, Harding, S, Hariprasad, Sm, Hartley, K, Hartman, P, Hartnett, Me, Harvey, P, Hassan, T, Headon, M, Hejsek, L, Higgins, P, Hillenkamp, J, Ho, A, Ho, T, Holekamp, N, Holz, E, Holz, F, Hooper, P, Hopkins, Jj, Hoskin Mott, A, Hoskins, J, Hrisomalos, N, Hsu, J, 3rd, Hubbard B., Hudson, H, Hughes, E, Hunt, A, Hunyor, A, Hwang, T, Hwang, Jf, Ibarra, M, Incarnato, N, Inhetvin Hutter, C, Introini, U, Isaacs, T, Islam, N, Iyer, Mn, Jablonski, C, Jack, Rl, Jager, R, Jahn, C, Jao, C, Jehan, F, Jonas, J, Joseph, D, Joshi, M, Jost, B, Jurklies, B, Kaincova, I, Kaiser, P, Kaiser, R, Kalvodova, B, Kamppeter, B, Kanann, Nb, Kang, K, Katz, Rs, Kaushal, S, Kecik, D, Kellaway, J, Kelly, K, Kelly, S, Khan, J, Kherani, A, Kim, R, Kim, I, Kim, J, Kim, Jg, Kim, N, Kim, Tw, Kingsley, R, Klein, R, Klemperer, I, Kociecki, J, Korbasova, M, Korda, V, Korobelnik, Jf, Koshy, Z, Kostamaa, H, Kovach, J, Kozak, I, Kozousek, V, Krasny, J, Kreiger, A, Krivosic, V, Krug JV Jr, Kruger, L, Kunimoto, D, Kuppermann, Bd, Kurtz, R, Kuznik Borkowska, A, Lai, J, Lai, W, Lake, S, Lalwani, G, Lam, Wc, Lanning, Rc, Lanzetta, Paolo, Lara, W, Larrison, Wi, Lattanzio, R, Lavina, A, Lavinsky, J, Lazzaroni, F, Lee, E, Lee, Jy, Lee, M, Lee, Sy, Lee, V, Leff, S, Lehr, J, Lenfesty, P, Leonard, R, Levine, A, Levitan, M, Lewis, H, Liew, S, Lim, J, Lim, R, Lin, R, Lip, Pl, Liu, J, Lobes, La, Loose, I, Lottenberg, Cl, Loutchkina, D, Lu, Dw, Lubczynska, A, Lujan, B, Lyssek Boron, A, Ma, C, Ma, P, Maberley, D, Maccumber, M, Madhusudhana, Kc, Madreperla, S, Magee, M, Magolan, J, Maia Ode O., Jr, Maia, A, Majji, A, Malthieu, D, Mango, C, Marmor, M, Marques, L, Martin, D, Martinez, Ja, Massaoutis, P, Mathur, R, Mattioli, S, Maturi, Rk, Mazur Michalek, I, Mcallister, I, Mccabe, F, Mccannel, Ca, Mcgimpsey, S, Mchugh, Jd, Mckibbin, M, McLean WC Jr, Mcmillan, T, Meireles, R, de Melo CS, Menchini, U, Meredith, T, Merrill, P, Mian, U, Michels, M, Midena, E, Mieler, Wf, Migliavacca, L, Miller, D, Miller, J, Mincey, G, Mitchell, P, Mizubuti, Sk, Mohamed, S, Mohammed, M, Moinfar, N, Moisseiev, J, Mones, J, Montemayor Lobo, R, Montero, J, de Moraes NI, Moreira CA Jr, Morely, M, Moreno, Jm, Moron, Jt, Morrison, Vl, Morse, L, Moshfeghi, A, Moshfeghi, D, Muccioli, C, Munshi, V, Murthy, Rc, Naing, T, Nair, R, Nascimento, J, Nascimento, Vp, Nawrocka, Z, Nawrocki, J, Newell, C, Newsom, R, Nguyen, J, Nguyen, Q, Nguyen, Rl, Nichols, J, Nilanjana, D, Noguchi, B, Noorily, S, Novack, R, Novak, M, Novalis, G, O'Brien, D, Offermann, I, Oguido, Ap, Oh, K, Okruszko, A, de Oliveira TL, Oliver, S, Ong, S, Orellana, J, Orzalesi, N, O'Toole, L, Ovando, Y, Paccione, J, Pach, J, Packo, K, Packowska, Ma, Palmer, J, Palmer, H, Palombi, K, Papp, A, Paques, M, Paranhos A., Jr, Park, D, Park, Ri, Park, S, Parke, D, Pastor Jimeno JC, Patel, S, Patra, S, Pavan, Pr, Pearce, I, Pecold, K, Pedio, M, Peh, Kk, Pelosini, L, Pendergast, S, Perez, Br, Perez Ortiz DJ, Perkins, S, Peters, M, Pheasant, T, Pilat, J, Pilotto, E, Piltz Seymour, J, Pirracchio, A, Pollack, A, Portella, E, Pracharova, Z, Prati, M, Prensky, Jg, Preston, R, Prieto, F, Puls, S, Purohit, Ar, Quintao, T, Rahhal, F, Rahman, W, Ramos, Ar, Ramsey, S, Rani, A, Rao, Pk, Rapizzi, E, Raskauskas, P, Ratiglia, R, Ratnakaram, R, Rauser, Me, Regillo, C, Rehak, J, Reichel, E, Reid, Da, Rejmont, L, Renaud Rougier MB, Ribon, Ri, Ricarova, R, Rich, R, Riley, A, Ripandelli, G, Rishi, E, Rivett, K, Rogers, A, Romanet, Jp, Rosa, Pj, Rosberger, D, Rose, S, Rosenfeld, P, Ross, Rr, Rotberg, M, Roth, Cb, Roth, D, Rubaltelli, D, Rubsamen, P, Ruby, A, Ruiz Moreno JM, Ruiz, R, Russell Gonder, J, Russell, M, Ryu, Jw, Sachs, H, Sadda, S, Safar, A, Salinas, C, Sall, K, Samad, A, Samkova, K, Sanders, J, Sandhu, R, Sandhu, Ss, Sandner, D, Sanislo, Sr, Sartani, G, Saviano, S, Savy, O, Schechter, Ba, Schenker, Hi, Schiff, W, Schlichtenbrede, F, Schneider, B, Schneider, L, Schneiderman, T, Schocket, L, Schoenherr, Schoenleber, D, Scholl, Hp, Schreiber, J, Schwartz, Sd, Sears, J, Sedlakova, J, Seery, C, Sell, C, Shah, G, Shapiro, M, Sharma, A, Sheidow, T, Sheu, Sj, Sheufele, T, Shukla, D, Siewec Proscinska, J, Silva, E, Singer, M, Singer, S, Singerman, Lj, Singh, M, Siow, Yc, Sipperley, Jo, Sivaprasad, S, Sjaarda, R, Snyder, W, Sobrin, L, Sodi, A, Solomon, S, Sonkin, P, Soubrane, G, Gisèle, P, Spirn, B, Srivastava, S, Stannard, K, Staurenghi, G, Steinmetz, R, Stepien, K, Stern, W, Stevenson, Od, Stewart, D, Stolba, U, Stoller, G, Stone, C, Stout, Jt, Stringfellow, G, Studnicka, J, Suarez Figueroa, M, Sung, J, Susini, A, Syracuse, R, Szaflik, J, Szlechter, M, Tabandeh, H, Tadayoni, R, Takahashi, Wy, Taleb, Ac, Talks, Sj, Tamayo, L, Tan, M, Taney, B, Tarnawska, D, Tassinari, G, Taylor, J, Telander, D, Territo, C, Thomas, M, Thompson, Jt, Thompson, Ws, Tiedeman, Js, Topping, T, Trese, M, Truong, S, Tsang, Cw, Tufail, T, Ufret Vincenty, R, Uhmannova, R, 2nd, Ulanski L., Ulinska, M, Urminsky, J, Uy, H, Vaishnav, H, Varano, M, Vavvas, D, Vega Sanz BF, Veloso, A, Vicha, I, Viola, F, Visser, L, Vlkova, E, Voelker, M, Volkert, D, Vossmerbaumer, U, Vu, C, Vyas, S, Walker, J, Walter, A, Andreas, R, Wasiak, K, Watt, Dr, Weger, M, 3rd, Weidman F., Weinberger, D, Weisz, Jm, 3rd, Wells J., Wheatley, M, Wickremasingh, S, Wiegand, T, Wieland, M, Will, D, Williams, G, Williams, Rg, Wilson, D, Win, Ph, Wing, Gl, Wirostko, W, Wirthlin, R, Wong, Al, Wong, T, Woo, J, Wu, Tt, Wylegala, E, Yan, J, Yang, Ch, Yang, Cm, Yang, Y, Yang, Yc, Yarian, D, Yates, P, Yedavally, S, Yoken, J, Young, L, Young, S, Zago, Rj, Zakov, Z, Zaras, M, Zegarra, H, Ziemianski, M, Zimmer Galler, I, Zourdani, A, and Zur, C.

Published
2010

9. Blunt trauma to the abdomen

Author

Haller Ja

Subjects
medicine.medical_specialty, Energy transfer, Resuscitation, Abdominal Injuries, Wounds, Nonpenetrating, Blunt, Medicine, Humans, Child, Cause of death, business.industry, Major trauma, Decision Trees, Infant, Newborn, Infant, medicine.disease, Surgery, medicine.anatomical_structure, Blunt trauma, Child, Preschool, Pediatrics, Perinatology and Child Health, Emergency medicine, Abdomen, business, Algorithms, Motor vehicle crash
Abstract

Serious injuries remain the number one cause of death among American children. Major trauma is responsible for more than 50% of the mortality in children between the ages of 1 and 14 years. The majority of these life-threatening injuries result from blunt trauma rather than from penetrating injuries, which are much more common in adults. The most common causes of blunt trauma to children are: motor vehicle crashes when a child is either a pedestrian, bicycle rider, or automobile occupant; falls from windows or farm buildings and machinery; and house fires. Children die in motor vehicle crashes as a result of multiple systems injuries, of which the most serious is to the head. Major blunt trauma to the abdomen frequently is associated with this series of injuries. This is a difficult injury to evaluate because often there are few signs of external damage to reflect the life-threatening trauma to internal abdominal organs. In addition, as noted previously, children commonly have associated head injuries and are unconscious at the time of evaluation, which makes early diagnosis and definitive treatment even more difficult, often resulting in disastrous delays in specific treatment. The pathophysiology of blunt injuries to the abdomen results from energy transfer of compression and crush forces or from rapid deceleration/acceleration forces, which cause shearing stresses within the abdomen.

Published
1996

10. Nonoperative management of solid organ injuries in children. Is it safe?

Author

Haller Ja, Pat A. Papa, Paul M. Colombani, and George Drugas

Subjects
medicine.medical_specialty, Adolescent, medicine.medical_treatment, Splenectomy, Poison control, Abdominal Injuries, Wounds, Nonpenetrating, Clinical Protocols, Laparotomy, Injury prevention, medicine, Humans, Prospective Studies, Child, Pediatric intensive care unit, business.industry, Infant, medicine.disease, Nephrectomy, Surgery, medicine.anatomical_structure, Treatment Outcome, Child, Preschool, Abdomen, business, Pediatric trauma, Research Article
Abstract

OBJECTIVE: The authors reviewed their experience with life-threatening blunt injuries in approximately 2900 children (0-14 years) admitted to the designated state pediatric shock trauma unit between 1990 and 1993. METHODS: During this time, the authors treated all severely injured children with a prospective, nonoperative protocol if they were hemodynamically stable after less than 40 mL/kg fluid replacement, had proven evidence of solid organ injuries and remained stable in the pediatric intensive care unit under surgical management. RESULTS: Twenty-eight children had computed tomography (CT) or operatively proven lacerations of the spleen, 25 had lacerations of the liver, 18 had lacerations of the kidney, 7 had lacerations of the pancreas, and 11 had two or more solid organ injuries. Three of the 28 children with injured spleens required laparotomy (two splenectomy, one splenorrhaphy). Two of the 25 children with liver injuries required laparotomy (one suturing, one partial resection). One of the 18 children with kidney injuries required laparotomy (nephrectomy), and 3 of the 7 children with pancreas injuries required laparotomy (two resection, one pseudocyst). There were three deaths after laparotomy (two head, one chest/abdominal). There were no deaths in the children managed nonoperatively, and there were no immediate or long-range complications. CONCLUSIONS: Comparison of the authors' data with the National Pediatric Trauma Registry shows similar results. The authors believe that nonoperative management of solid organ injuries under careful surgical observation in a pediatric intensive care unit is safe and appropriate. Language: en

Published
1994

12. To the editor

Author

White Jj and Haller Ja

Subjects
medicine.medical_specialty, business.industry, Gastroschisis, Pediatrics, Perinatology and Child Health, Silo, medicine, Surgery, General Medicine, Silastic, business, medicine.disease
Published
2000
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15. Panel

Author

Lewis Fr, Luterman A, Jacobs Lm, Aprahamian C, Border, and Haller Ja

Subjects
business.industry, SCOOP, Medicine, Surgery, Medical emergency, Critical Care and Intensive Care Medicine, Trauma care, business, medicine.disease, computer, computer.programming_language
Published
1983
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16. Reoperation after total correction of tetralogy of Fallot

Author

Vincent L. Gott, Robert K. Brawley, James S. Donahoo, and Haller Ja

Subjects
Pulmonary and Respiratory Medicine, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, business.industry, Mortality rate, Regurgitation (circulation), medicine.disease, Ventriculotomy, Right ventricular hypertension, Tricuspid Valve Insufficiency, Internal medicine, Primary operation, cardiovascular system, Cardiology, Medicine, Surgery, cardiovascular diseases, Tetralogy, Cardiology and Cardiovascular Medicine, business, Tetralogy of Fallot
Abstract

Fifteen patients have required repeat heart surgery after total correction of tetralogy of Fallot. Indications for reoperation included recurrent ventricular septal defect (VSD), 9 patients; tricuspid regurgitation, 2 patients; residual right ventricular hypertension, 1 patient; and infection of the right ventriculotomy, 3 patients. From this experience, we have drawn the following conclusions: (1) The need for reoperation after correction of Fallot's tetralogy is unusual; (2) although technically more difficult than the primary operation, the second operation does not cause an excessive mortality rate (13 of 15 survived), and (3) properly selected patients derive substantial benefit from reoperation.

Published
1974
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17. Neonatal Necrotizing Enterocolitis: An Update

Author

Schneider Pa, Ghory Mj, Colombani P, Haller Ja, Buck, and David L. Dudgeon

Subjects
Pediatrics, medicine.medical_specialty, Neonatal necrotizing enterocolitis, business.industry, Perforation (oil well), Infant, Newborn, Gestational age, Gestational Age, Retrospective cohort study, General Medicine, Disease, medicine.disease, Infant newborn, Intensive care unit, Infant, Newborn, Diseases, law.invention, Sepsis, Recurrence, law, medicine, Humans, business, Enterocolitis, Pseudomembranous, Retrospective Studies
Abstract

We reviewed 91 cases of neonatal necrotizing enterocolitis (NNEC), which continues to be a devastating disease occurring in 2% to 4% of all newborn intensive care unit admissions. Onset now occurs in older infants (11.9 days). The morbidity is significant (22%), with strictures (8%) and recurrences (8%) the primary problems. Recurrences are more likely to require surgical intervention and result in a high mortality. Early diagnosis of necrotic bowel before perforation, peritoneal contamination, and sepsis is difficult and contributes to the still high, but improved, overall mortality of 36%.

Published
1984
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18. Thrombectomy for Deep Thrombophlebitis of the Leg

Author

Haller Ja

Subjects
Peripheral Vascular Diseases, Venous Thrombosis, Leg, medicine.medical_specialty, business.industry, Deep thrombophlebitis, General Medicine, Thrombophlebitis, Normal flow, Surgery, Conservative treatment, Humans, Medicine, Vascular Diseases, High incidence, business, Complication, Thrombectomy
Abstract

Dissatisfaction with the high incidence of postphlebitic limb after massive deep thrombophlebitis has prompted the use of thrombectomy in an attempt to diminish this discouraging complication. In the belief that thrombectomy will not only remove a fresh clot that might become fragmented but also restore normal flow through undamaged valves 33 patients were operated upon in the acute phase of the disease. It is the purpose of this paper to report the results of this experience in the University of Louisville Hospitals. The conservative treatment of deep thrombophlebitis has been directed toward the prevention of two serious complications: fragmentation of . . .

Published
1962
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21. Pectus excavatum

Author

John J. White, Mazur D, Peters Gn, and Haller Ja

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Pectus excavatum, business.industry, General surgery, Medicine, Surgery, Cardiology and Cardiovascular Medicine, business, medicine.disease
Published
1970
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22. Cinefluorographic and Manometric Evaluation of the Motor Function of the Esophagus Following Segmental Resection in Newborn Dogs

Author

Gatewood Om, John J. Vanhoutte, Talbert Jl, Haller Ja, and Andrew F. Brooker

Subjects
medicine.medical_specialty, Manometry, business.industry, Cineradiography, Lumen (anatomy), Tracheoesophageal fistula, Anastomosis, medicine.disease, Dysphagia, Surgery, Dogs, Esophagus, medicine.anatomical_structure, Esophagoplasty, Atresia, medicine, Animals, Radiology, Nuclear Medicine and imaging, Segmental resection, medicine.symptom, Abnormality, business
Abstract

The most common long-term sequelae encountered in patients with reconstructions for esophageal atresia and tracheoesophageal fistula are dysphagia and recurrent pneumonia. Earlier observers have considered these secondary to narrowing at the site of the anastomosis (7, 9, 10). More recent observations have demonstrated that a correlation does not always exist between the size of the lumen of the esophagus at the anastomosis and the patient's clinical symptoms (2, 5, 8). Delayed emptying of the esophagus below the anastomosis has also been noted (2, 8). Abnormal motility patterns in the esophagus distal to the site of surgical intervention have been roentgenographically and manometrically demonstrated by several authors (2, 4, 5, 8, 11). Two explanations for this abnormal behavior have been advanced : (a) it results from a coexistent congenital neuromuscular abnormality of the esophagus, and (b) it is the consequence of trauma to the vagus nerves at the time of surgical reconstruction (2, 8). The following...

Published
1966
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23. Surgical Treatment of Deep Thrombophlebitis of the Leg

Author

Haller Ja

Subjects
Venous Thrombosis, Leg, medicine.medical_specialty, Heparin, business.industry, Deep thrombophlebitis, Anticoagulants, Extremities, General Medicine, Thrombophlebitis, Vascular surgery, medicine.disease, Surgery, Edema, medicine, Humans, medicine.symptom, Surgical treatment, business, Vascular Surgical Procedures, medicine.drug
Published
1964
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24. Combined Aortic and Mitral Insufficiency–Hemodynamic Effects of the Hufnagel Valve

Author

Andrew G. Morrow, Roshe J, and Haller Ja

Subjects
Heart Defects, Congenital, Aortic valve disease, medicine.medical_specialty, Heart Diseases, business.industry, Mitral valve diseases, Heart Valve Diseases, Hemodynamics, Mitral Valve Insufficiency, Articles, Bicuspid Aortic Valve Disease, Aortic Valve, Internal medicine, Cardiology, medicine, Humans, Mitral Valve, Disease, Surgery, business, Aorta, Hemodynamic effects
Published
1956
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25. Diagnosis and Surgical Correction of Congenital Coronary Artery-Coronary Sinus Fistula

Author

Haller Ja and Little Ja

Subjects
Heart Defects, Congenital, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, Fistula, Figural Aftereffect, Physiology (medical), Ductus arteriosus, Humans, Medicine, cardiovascular diseases, Cardiac Surgical Procedures, Coronary sinus, business.industry, Coronary Sinus, Thoracic Surgery, Congenital coronary arteriovenous fistula, Surgical correction, medicine.disease, Coronary Vessels, medicine.anatomical_structure, Cardiothoracic surgery, cardiovascular system, Radiology, Abnormality, Cardiology and Cardiovascular Medicine, business, Artery
Abstract

Congenital coronary arteriovenous fistula is easily confused with patent ductus arteriosus. An illustrative case is presented which emphasizes the special tests that are necessary to establish the diagnosis. Finally, the successful surgical correction of this abnormality is described.

Published
1963
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26. TRAUMA WORKSHOP REPORT

Author

Haller Ja and Talbert Jl

Subjects
Injury control, business.industry, Accident prevention, Human factors and ergonomics, Poison control, Critical Care and Intensive Care Medicine, medicine.disease, Suicide prevention, Occupational safety and health, Injury prevention, Medicine, Surgery, Medical emergency, business
Published
1970
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27. Special problems of vascular injuries in children

Author

White Jj, Richard D. Signer, Shaker Ij, Haller Ja, and Golladay Es

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Incidence (epidemiology), Iatrogenic Disease, Pediatric age, Wounds, Penetrating, Critical Care and Intensive Care Medicine, Wounds, Nonpenetrating, Frequent use, Blood Vessel Prosthesis, Catheterization, medicine, Blood Vessels, Humans, Surgery, business, Child, Ligation, Growth Disorders
Abstract

Vascular injuries in children are not rare. The rising incidence of general trauma in children and the frequent use of diagnostic procedures in this age group may contribute to an overall increase in these injuries. A 10-year experience with severe vascular injuries in children at The Johns Hopkins Hospital has been reviewed. The mechanisms of production may be similar to those in adults, but many injuries are unique to the pediatric age group. The sequelae of such injuries in infants and children may include abnormal growth and development of the involved extremity. Complications and special surgical management of our group of 71 children have been discussed and preventive measures have been suggested.

Published
1976

28. Organization and function of a regional pediatric trauma center: does a system of management improve outcome?

Author

James R. Buck, Hall J, Shorter N, Paul M. Colombani, Haller Ja, and D. Miller

Subjects
medicine.medical_specialty, Adolescent, Critical Care and Intensive Care Medicine, Regional Health Planning, law.invention, Management Information Systems, Trauma Centers, law, medicine, Humans, Intensive care medicine, Child, Pediatric intensive care unit, Coma, Maryland, business.industry, Mortality rate, Trauma center, Infant, Newborn, Infant, Hospital Bed Capacity, 500 and over, medicine.disease, Intensive care unit, Outcome and Process Assessment, Health Care, Blunt trauma, Child, Preschool, Emergency medicine, Wounds and Injuries, Surgery, medicine.symptom, business, Pediatric trauma, First aid, Information Systems
Abstract

Since 1975, more than one thousand children with life-threatening injuries have been preferentially transported to our statewide Regional Pediatric Trauma Center by helicopter or city ambulance. Initial care is provided by emergency medical technicians with special instruction in the handling of pediatric trauma. More than half the children admitted to our service were injured in motor vehicle/pedestrian or motor vehicle/bicycle accidents. Have care and outcome improved? This system provides for excellent first aid at the scene and more rapid radio-directed transport to the trauma center where in-hospital management is provided by pediatric and surgical personnel experienced in the treatment of all aspects of childhood trauma. We have organized weekly trauma morbidity and mortality rounds and have established a trauma registry and index of severity. Pelvic fractures from blunt trauma had a mortality in this series of 1.4%, the lowest of any reported experience. Between January 1976 and December 1979, 46 children with coma of longer than 24 hours' duration were treated in the Pediatric Intensive Care Unit. The mortality rate was still high (38%) but employing intracranial monitoring and aggressive control of brain edema, 88% of the survivors had a good recovery without major motor or intellectual defects. The large volume of cases allows for development and evaluation of new techniques in trauma management and invaluable experience in the training of general surgical residents, pediatricians, and emergency physicians.

Published
1983

29. Acute thoracic injuries in children

Author

Shermeta Dw and Haller Ja

Subjects
medicine.medical_specialty, Rib Fractures, Thoracic Injuries, business.industry, Respiration, Hemorrhage, Pulmonary Edema, Arteries, Airway Obstruction, Text mining, Heart Injuries, Pediatrics, Perinatology and Child Health, Emergency medicine, Acute Disease, Medicine, Humans, business, Child, Physical Examination
Published
1976

30. Spontaneous rupture of the stomach in the newborn: clinical and experimental evaluation

Author

Haller Ja, James Ae, White Jj, John P. Dorst, Shaker Ij, Schaefer Ja, and Richard M. Heller

Subjects
Spontaneous rupture, medicine.medical_specialty, Supine position, Guinea Pigs, Infant, Newborn, Diseases, Stomach Rupture, Dogs, medicine, Pressure, Animals, Humans, business.industry, Experimental model, Stomach, Air, digestive, oral, and skin physiology, Age Factors, Infant, Newborn, digestive system diseases, Surgery, Rats, Disease Models, Animal, medicine.anatomical_structure, Animals, Newborn, Anesthesia, Pediatrics, Perinatology and Child Health, business
Abstract

Our study presents an experimental model for studying gastric rupture in the newborn. We showed that gastric rupture could be produced in eight newborn rodents and in three puppies less than 10 days old after injection of 120 ml air at 100 mm Hg pressure in the rodents and 175 ml air at 240 mm Hg pressure in the puppies. Gastric rupture occurred with animals supine and with approximately 20 ml barium injected into the stomach. Positioning of the animal in the supine position permitted the barium to pool in the antral-pyloric region of the stomach.

Published
1976

31. Patent ductus arteriosus with reverse flow

Author

Stevenson Td, Morrow Ag, London F, and Haller Ja

Subjects
medicine.medical_specialty, medicine.anatomical_structure, DUCTUS ARTERIOSUS PATENT, business.industry, Ductus arteriosus, Internal medicine, Cardiology, Medicine, Humans, General Medicine, Ductus Arteriosus, business, Ductus Arteriosus, Patent
Published
1957

32. Congenital inguinal hernia and inguinal herniography

Author

Haller Ja, Dorst Jp, and John J. White

Subjects
Male, medicine.medical_specialty, Congenital inguinal hernia, business.industry, General surgery, Radiography, MEDLINE, Infant, Newborn, Infant, Hernia, Inguinal, medicine.disease, Surgery, Child, Preschool, Methods, Medicine, Humans, Hernia, Female, business
Published
1970

33. Metabolic alterations in shock: the effect of controlled reduction of blood flow on oxidative metabolism and catecholamine response

Author

Cahill Jl, Haller Ja, and Ward Mj

Subjects
medicine.medical_specialty, Extracorporeal Circulation, Epinephrine, medicine.medical_treatment, Blood Pressure, Critical Care and Intensive Care Medicine, Body Temperature, Catecholamines, Dogs, Internal medicine, medicine, Animals, Cardiac Output, Pyruvates, Reduction (orthopedic surgery), Acid-Base Equilibrium, Oxidative metabolism, business.industry, Shock, Blood flow, Models, Theoretical, Endocrinology, Shock (circulatory), Catecholamine, Lactates, Surgery, medicine.symptom, Blood Gas Analysis, business, Blood Flow Velocity, medicine.drug
Published
1967

34. Treatment of deep-vein thrombosis

Author

Haller Ja

Subjects
Venous Thrombosis, medicine.medical_specialty, business.industry, Deep vein, Femoral vein, Thrombosis, General Medicine, Femoral Vein, Iliac Vein, medicine.disease, Surgery, medicine.anatomical_structure, Medicine, Humans, business
Published
1962

35. THE EFFECT OF NEONATAL SPLENECTOMY ON MORTALITY FROM RUNT DISEASE IN MICE

Author

Haller Ja

Subjects
Transplantation, Cachexia, business.industry, medicine.medical_treatment, Research, Splenectomy, Graft vs Host Disease, Spleen, Growth, medicine.disease, Congenital Abnormalities, Runt disease, Mice, medicine.anatomical_structure, Animals, Newborn, Immunology, Genetics, Medicine, Animals, business
Published
1964

36. The treatment of single gunshot wounds of the chest

Author

Haller Ja, Canan Ed, and Ransdell Ht

Subjects
Thorax, medicine.medical_specialty, Thoracic Injuries, business.industry, MEDLINE, Medicine, Humans, Surgery, Wounds, Gunshot, Radiology, Critical Care and Intensive Care Medicine, business
Published
1962

37. Studies of the origin of the vasculature in free skin grafts

Author

R E Billingham and Haller Ja

Subjects
Pathology, medicine.medical_specialty, Text mining, business.industry, Cricetinae, Medicine, Animals, Transplantation, Homologous, Surgery, Skin Transplantation, business, Skin, Research Article
Published
1967

38. Long-Term Evaluation of Tetralogy Patients with Pulmonary Valvular Insufficiency Resulting from Outflow-Patch Correction Across the Pulmonic Annulus

Author

C R Conti, Jones El, Robert K. Brawley, Haller Ja, Catherine A. Neill, and Vincent L. Gott

Subjects
Adult, Cardiac Catheterization, medicine.medical_specialty, Adolescent, Heart Ventricles, medicine.medical_treatment, Blood Pressure, Pulmonary Artery, Asymptomatic, Electrocardiography, Postoperative Complications, Physiology (medical), Internal medicine, medicine, Humans, Ventricular outflow tract, cardiovascular diseases, Tetralogy, Heart Aneurysm, Polytetrafluoroethylene, Tetralogy of Fallot, Cardiac catheterization, Annulus (mycology), Pulmonary Valve, Polyethylene Terephthalates, business.industry, Mortality rate, Prostheses and Implants, medicine.disease, Pulmonary Valve Insufficiency, Tricuspid Valve Insufficiency, Surgery, cardiovascular system, Cardiology, Ventricular pressure, Cineangiography, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract

In the operative correction of tetralogy of Fallot with a severely narrowed right ventricular outflow tract, widening of the pulmonic annulus is frequently necessary to prevent a high residual pressure gradient and to reduce right ventricular pressure overload. This can be accomplished by incising the pulmonic annulus and inserting a patch graft across the valve, but this usually results in pulmonary valvular insufficiency. Of 426 patients who underwent total correction of Fallot's tetralogy between 1959 and 1970, 63 required a patch across the pulmonic annulus. The mortality rate for this group was 30.1%, compared with a total mortality among the 426 patients of 18%. The high mortality rate is influenced by the fact that the majority were corrected in the early years of the series. Fifteen patients were restudied by cardiac catheterization and cineangiography an average of 9.1 years after total correction. Twelve patients were asymptomatic and three patients had only mild symptoms on exertion in spite of angiographically significant pulmonic regurgitation. The average right ventricular systolic pressure was 40 mm Hg; right ventricular end-diastolic pressure was 7 mm Hg; and the right ventricular/pulmonary arterial peak systolic pressure gradient was 14.9 mm Hg. This experience suggests that after a more difficult immediate postoperative period, patients who have right ventricular outflow reconstruction with patches across the pulmonic ic annulus tolerate their chronic pulmonic regurgitation very well.

Published
1973
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39. Effect of newborn splenectomy on homograft survival in inbred mice

Author

van der Salm T, Haller Ja, and Rauenhorst J

Subjects
Litter (animal), Transplantation, medicine.medical_specialty, business.industry, medicine.medical_treatment, Splenectomy, Physiology, Skin Transplantation, Surgery, Serology, body regions, Homograft rejection, Mice, surgical procedures, operative, Animals, Newborn, Transplantation Immunology, Immunology, Immune Tolerance, medicine, Animals, Transplantation, Homologous, business
Abstract

Splenectomy was carried out in newborn and in 3-, 6-, and 9-day-old mice. The survivors and their sham-operated litter mates were homografted with skin at 42+ days of age. The survival times of the homografts were normal and identical in the two groups of mice. These results suggest that splenectomy at birth and shortly thereafter does not alter the immunologic mechanism responsible for homograft rejection in mice.

Published
1967

41. Regional Pediatric Trauma Center: Does a System of Management Improve Outcome?1

Author

Haller Ja and Shorter N

Subjects
medicine.medical_specialty, business.industry, Trauma center, Human factors and ergonomics, Poison control, Traumatology, medicine.disease, Suicide prevention, Occupational safety and health, Pediatrics, Perinatology and Child Health, Injury prevention, Emergency medicine, Medicine, Surgery, Medical emergency, business, Pediatric trauma
Abstract

The Pediatric Trauma Center has existed in Maryland since 1973 for the entire state with the exception of burns and isolated eye or hand injuries which are managed in affiliated hospitals. The article reviews the system and the results obtained in 600 children treated between 1975 and 1981. The authors underline the need for a regional trauma center because this system can reduce the morbidity and mortality associated with trauma in the pediatric age group. Language: en

Published
1982
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42. Pediatric trauma. The No. 1 killer of children

Author

Haller Ja

Subjects
Pediatrics, medicine.medical_specialty, education.field_of_study, Rehabilitation, business.industry, medicine.medical_treatment, Population, Age Factors, Poison control, General Medicine, medicine.disease, Suicide prevention, United States, Occupational safety and health, Trauma Centers, Injury prevention, Emergency Medicine, medicine, Humans, Wounds and Injuries, Tragedy (event), Child, education, business, Pediatric trauma
Abstract

WE HEAR so much about the tragic loss of children from congenital heart disease, lung abnormalities, and malignancy that we have overlooked the fact that more than half of the children who die in the United States die as a result of serious injuries. Almost half of the deaths in children last year resulted from trauma, as compared with approximately one death in 20 in the general population due to injuries. The death of a child is, in itself, a tragedy, but crippling injuries to a child and the resulting need for rehabilitation may have a far greater impact on society and our health care system than a child's death will. The expenditure of resources and personnel and the economic loss caused by termination of work potential when a child is seriously handicapped are relatively enormous when compared with similar losses following injuries in adults. A child is usually affected

Published
1983
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45. Efficacy and Safety of Intravitreal Gene Therapy for Leber Hereditary Optic Neuropathy Treated within 6 Months of Disease Onset

Author

Irena Tsui, Claudia B. Catarino, Piero Barboni, Günther Rudolph, Nancy J. Newman, Sara Silvestri, Alfredo A. Sadun, Michael Dattilo, Neringa Jurkute, Jean-François Girmens, Cosima Schertler, Magali Taiel, Rustum Karanjia, Claudia Priglinger, Maria K Gemenetzi, Armin Wolf, Manuela Contin, Jasmina Al-Tamami, Thomas Klopstock, James Acheson, Robert C. Sergott, Deborah Gibbs, Rabih Hage, Stephan R. Thurau, Adam A. DeBusk, Lidia Di Vito, Mark L. Moster, Valérie Biousse, Med Lindreth DuBois, Valerio Carelli, Gad Heilweil, Chiara La Morgia, Michele Carbonelli, Andrew Hendrick, Patrick Yu-Wai-Man, Jason H. Peragallo, Gerard Smits, Angelika Pressler, Martin Hildebrandt, Alcides Fernandes Filho, Michael Neuenhahn, Bettina von Livonius, Barrett Katz, Daniel R Muth, Siegfried G. Priglinger, Lauren Leitch-Devlin, Susan Mohamed, William R. Tucker, Maria Massini, Maria Eleftheriadou, Laure Blouin, Catherine Vignal-Clermont, Eman Hawy, Simona Degli Esposti, Heather Tollis, G. Baker Hubbard, Jannah Rutter Dobbs, José-Alain Sahel, Catherine Vignal, Melissa SantaMaria, Julie A. Haller, Emory University School of Medicine, Emory University [Atlanta, GA], Addenbrooke's Hospital, Cambridge University NHS Trust, Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), University of Bologna, Jefferson (Philadelphia University + Thomas Jefferson University), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO), Ludwig-Maximilians-Universität München (LMU), University of California [Los Angeles] (UCLA), University of California, Ludwig Maximilian University [Munich] (LMU), Institut de la Vision, Centre National de la Recherche Scientifique (CNRS)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Pittsburgh School of Medicine, Pennsylvania Commonwealth System of Higher Education (PCSHE), Institut Hospitalo-Universitaire FOReSIGHT, Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO)-Sorbonne Université (SU), Newman, NJ, Yu-Wai-Man, P, Carelli, V, Moster, ML, Biousse, V, Vignal-Clermont, C, Sergott, RC, Klopstock, T, Sadun, AA, Barboni, P, DeBusk, AA, Girmens, JF, Rudolph, G, Karanjia, R, Taiel, M, Blouin, L, Smits, G, Katz, B, Sahel, J-A, Vignal, C, Hage, R, Catarino, CB, Priglinger, C, Priglinger, S, Thurau, S, von Livonius, B, Muth, D, Wolf, A, Al-Tamami, J, Pressler, A, Schertler, C, Hildebrandt, M, Neuenhahn, M, Heilweil, G, Tsui, I, Hubbard, GB, Hendrick, A, Dattilo, M, Peragallo, J, Hawy, E, DuBois, Med L, Gibbs, D, Filho, AF, Dobbs, J, Carbonelli, M, Di Vito, L, Contin, M, Mohamed, S, La Morgia, C, Silvestri, S, Acheson, J, Eleftheriadou, M, Esposti, S, Gemenetzi, M, Leitch-Devlin, L, Tucker, WR, Jurkute, N, SantaMaria, M, Tollis, H, Haller, JA, and Massini, M.

Subjects
Male, Time Factors, Visual acuity, genetic structures, physiology [Visual Fields], [SDV]Life Sciences [q-bio], efficacy, Visual Acuity, Phases of clinical research, genetics [Dependovirus], chemistry.chemical_compound, 0302 clinical medicine, Visual Field Test, Quality of life, Clinical endpoint, Contrast (vision), intravitreal gene therapy, media_common, 0303 health sciences, physiology [Visual Acuity], Diabetic retinopathy, Dependovirus, Middle Aged, Dependoviru, genetics [DNA, Mitochondrial], Phase 3 randomized double-masked clinical trial, Treatment Outcome, Intravitreal Injections, diagnosis [Optic Atrophy, Hereditary, Leber], Female, Genetic Vector, medicine.symptom, Human, Adult, safety, LEBER HEREDITARY OPTIC NEUROPATHY, medicine.medical_specialty, retinal anatomic measures, Time Factor, Adolescent, media_common.quotation_subject, psychology [Optic Atrophy, Hereditary, Leber], Genetic Vectors, Visual Field, Humphrey visual field perimetry, Optic Atrophy, Hereditary, Leber, therapy [Optic Atrophy, Hereditary, Leber], DNA, Mitochondrial, bilateral visual improvement, Follow-Up Studie, Leber Hereditary Optic Neuropathy, Young Adult, 03 medical and health sciences, Double-Blind Method, Ophthalmology, psychology [Quality of Life], Electroretinography, medicine, Humans, ddc:610, Aged, 030304 developmental biology, contrast sensitivity, business.industry, Intravitreal Injection, Retinal, Genetic Therapy, retinal anatomic measure, medicine.disease, eye diseases, genetics [Optic Atrophy, Hereditary, Leber], chemistry, Mutation, 030221 ophthalmology & optometry, Visual Field Tests, sense organs, Visual Fields, business, Follow-Up Studies, best-corrected visual acuity
Abstract

International audience; Purpose: To evaluate the efficacy of a single intravitreal injection of rAAV2/2-ND4 in subjects with visual loss from Leber hereditary optic neuropathy (LHON).Design: RESCUE is a multicenter, randomized, double-masked, sham-controlled, phase 3 clinical trial.Participants: Subjects with the m.11778G>A mitochondrial DNA mutation and vision loss ≤6 months from onset in 1 or both eyes were included.Methods: Each subject's right eye was randomly assigned (1:1) to treatment with rAAV2/2-ND4 (single injection of 9 × 1010 viral genomes in 90 μl) or to sham injection. The left eye received the treatment not allocated to the right eye.Main outcome measures: The primary end point was the difference of the change from baseline in best-corrected visual acuity (BCVA) between rAAV2/2-ND4-treated and sham-treated eyes at week 48. Other outcome measures included contrast sensitivity, Humphrey visual field perimetry, retinal anatomic measures, and quality of life. Follow-up extended to week 96.Results: Efficacy analysis included 38 subjects. Mean age was 36.8 years, and 82% were male. Mean duration of vision loss at time of treatment was 3.6 months and 3.9 months in the rAAV2/2-ND4-treated eyes and sham-treated eyes, respectively. Mean baseline logarithm of the minimum angle of resolution (logMAR) BCVA (standard deviation) was 1.31 (0.52) in rAAV2/2-ND4-treated eyes and 1.26 (0.62) in sham-treated eyes, with a range from -0.20 to 2.51. At week 48, the difference of the change in BCVA from baseline between rAAV2/2-ND4-treated and sham-treated eyes was -0.01 logMAR (P = 0.89); the primary end point of a -0.3 logMAR (15-letter) difference was not met. The mean BCVA for both groups deteriorated over the initial weeks, reaching the worst levels at week 24, followed by a plateau phase until week 48, and then an improvement of +10 and +9 Early Treatment Diabetic Retinopathy Study letters equivalent from the plateau level in the rAAV2/2-ND4-treated and sham-treated eyes, respectively.Conclusions: At 96 weeks after unilateral injection of rAAV2/2-ND4, LHON subjects carrying the m.11778G>A mutation treated within 6 months after vision loss achieved comparable visual outcomes in the injected and uninjected eyes.

Published
2021
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46. Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion

Author

Peter Kaiser, Beatriz Fernandez-Vega Sanz, Jan Studnicka, Magdalena Ulinska, Lilianne Duarte, Sobha Sivaprasad, Richard Newsom, Nicole Eter, Alain Gaudric, Jose M Ruiz-Moreno, Tom Sheidow, AGNES GLACET-BERNARD, Darius Mohammad Moshfeghi, Rubens Belfort Jr, Rohan Essex, Jose Garcia-Arumi, Dirk Sandner, Francesco Bandello, CHUNG-MAY YANG, António Joaquim Rodrigues Castanheira Dinis, Dorota Tarnawska, Orna Geyer, Jean-Francois GIRMENS, Victor Chong, Demetrios Vavvas, Samantha Fraser-Bell, Michel Paques, Haller, Ja, Bandello, Francesco, Belfort, R, Blumenkranz, M, Gillies, M, Heier, J, Loewenstein, A, Yoon, Yh, Jiao, J, Li, Xy, and Whitcup, Sm

Subjects
Intraocular pressure, medicine.medical_specialty, Visual acuity, genetic structures, business.industry, medicine.medical_treatment, Cataract surgery, medicine.disease, eye diseases, Surgery, Ophthalmology, Central retinal vein occlusion, medicine, Dexamethasone Intravitreal Implant, sense organs, Implant, medicine.symptom, Prospective cohort study, business, Macular edema
Abstract

Objective: To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO). Design: Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension. Participants: We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO. Methods: At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was 250 mu m. Main Outcome Measures: The primary outcome for the open-label extension was safety; BCVA was also evaluated. Results: At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a >= 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A >= 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively. Conclusions: Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2011; 118: 2453-2460 (C) 2011 by the American Academy of Ophthalmology.

Published
2011

47. Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion

Author

Peter Kaiser, Beatriz Fernandez-Vega Sanz, Jan Studnicka, Magdalena Ulinska, Lilianne Duarte, Sobha Sivaprasad, Richard Newsom, Nicole Eter, Alain Gaudric, Jose M Ruiz-Moreno, Tom Sheidow, AGNES GLACET-BERNARD, Darius Mohammad Moshfeghi, Rubens Belfort Jr, Rohan Essex, Jose Garcia-Arumi, Dirk Sandner, Francesco Bandello, CHUNG-MAY YANG, António Joaquim Rodrigues Castanheira Dinis, Dorota Tarnawska, Orna Geyer, Jean-Francois GIRMENS, Victor Chong, Demetrios Vavvas, Samantha Fraser-Bell, Michel Paques, Haller, Ja, Bandello, Francesco, Belfort, R, Blumenkranz, M, Gillies, M, Heier, J, Loewenstein, A, Yoon, Yh, Jacques, Ml, Jiao, J, Li, Xy, and Whitcup, Sm

Subjects
medicine.medical_specialty, Intraocular pressure, Visual acuity, genetic structures, business.industry, medicine.medical_treatment, Cataract surgery, medicine.disease, eye diseases, Surgery, Ophthalmology, Central retinal vein occlusion, Dexamethasone Intravitreal Implant, Medicine, Branch retinal vein occlusion, Implant, medicine.symptom, business, Macular edema
Abstract

Objective: To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Design: Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO). Participants: A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO. Intervention: A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426). Main Outcome Measures: The primary outcome measure for the pooled data from the 2 studies was time to achieve a >= 15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety. Results: After a single administration, the time to achieve a >= 15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P= 15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P= 15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P 25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. There was no significant between-group difference in the occurrence of cataract or cataract surgery. Conclusions: Dexamethasone intravitreal implant can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with ME secondary to BRVO or CRVO and may be a useful therapeutic option for eyes with these conditions.

Published
2010

48. Disparities in Retinal Vein Occlusion Presentation and Initiation of Anti-VEGF Therapy: An Academy IRIS® Registry Analysis.

Author

Haller JA, Tomaiuolo M, Lucas MM, Yang CC, and Hyman L

Subjects
Humans, Female, Male, Retrospective Studies, Aged, Middle Aged, Bevacizumab administration & dosage, Academies and Institutes, United States epidemiology, Tomography, Optical Coherence methods, Follow-Up Studies, Ranibizumab administration & dosage, Receptors, Vascular Endothelial Growth Factor administration & dosage, Receptors, Vascular Endothelial Growth Factor antagonists & inhibitors, Aged, 80 and over, Retinal Vein Occlusion drug therapy, Retinal Vein Occlusion diagnosis, Angiogenesis Inhibitors administration & dosage, Vascular Endothelial Growth Factor A antagonists & inhibitors, Registries, Intravitreal Injections, Visual Acuity
Abstract

Objective: Investigate disparities in retinal vein occlusion (RVO) presentation and initiation of anti-VEGF treatment., Design: Retrospective cohort study., Subjects: Patients in the American Academy of Ophthalmology IRIS® (Intelligent Research in Sight) Registry database (2015-2021) with branch or central RVO and macular edema (ME)., Methods: The association of demographic characteristics and presenting visual acuity (VA) with anti-VEGF treatment initiation were quantified using multivariable logistic regression., Main Outcome Measures: Treatment with ≥ 1 anti-VEGF injection within 12 months after RVO diagnosis., Results: A total of 304 558 eligible patients with RVO and ME were identified. Age at presentation varied by race, ethnicity, sex, and RVO type (all P values < 0.001). Within the first year after RVO presentation, 192 602 (63.2%) patients received ≥ 1 anti-VEGF injection. In a multivariable regression model adjusting for relevant covariates, female (vs. male) patients had lower odds of receiving injections (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.93-0.96; P < 0.0001) as did Black/African American (vs. White) patients (OR, 0.90; 95% CI, 0.88-0.92; P < 0.0001) and Asian (vs. White) patients (OR, 0.95; 95% CI, 0.91-0.99; P = 0.02), whereas older patients (vs. patients aged < 51 years) had higher odds (61-70 years: OR, 1.20; 95% CI, 1.16-1.24; 71-80 years: OR, 1.20; 95% CI, 1.16-1.24; > 80 years: OR, 1.15; 95% CI, 1.11-1.18; all P values < 0.0001). Hispanic (vs. non-Hispanic) patients had a small increased odds of treatment initiation (OR, 1.08; 95% CI, 1.04-1.11; P < 0.0001). Results were similar in the subset of 226 143 patients with VA data. In this subset, patients with presenting VA < 20/40 to 20/200 were most frequently treated in the first year after diagnosis (∼ 70%) and patients with light perception/no light perception (LP-NLP) vision or VA of 20/20 or better were treated least frequently (36.9% and 41.9%, respectively)., Conclusions: In this large national clinical registry, 37% of RVO patients with ME had no anti-VEGF treatment documented in the first year after diagnosis. Black/African American, Asian, and female patients and patients with VA of LP-NLP were least likely to receive treatment. Awareness of this undertreatment and these disparities highlight the need for initiatives to ensure all RVO patients receive timely anti-VEGF injections for optimized visual outcomes., Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Published
2024
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49. Exploring the Associated Genetic Causes of Diabetic Retinopathy as a Model of Inflammation in Retinal Diseases.

Author

Cappellani F, Regillo CD, Haller JA, Gagliano C, and Pulido JS

Subjects
Humans, Proteomics methods, Transcriptome, Gene Ontology, Protein Interaction Maps genetics, Gene Expression Profiling, Diabetic Retinopathy genetics, Diabetic Retinopathy metabolism, Biomarkers, Inflammation genetics, Inflammation metabolism
Abstract

To investigate potential biomarkers and biological processes associated with diabetic retinopathy (DR) using transcriptomic and proteomic data. The OmicsPred PheWAS application was interrogated to identify genes and proteins associated with DR and diabetes mellitus (DM) at a false discovery rate (FDR)-adjusted p -value of <0.05 and also <0.005. Gene Ontology PANTHER analysis and STRING database analysis were conducted to explore the biological processes and protein interactions related to the identified biomarkers. The interrogation identified 49 genes and 22 proteins associated with DR and/or DM; these were divided into those uniquely associated with diabetic retinopathy, uniquely associated with diabetes mellitus, and the ones seen in both conditions. The Gene Ontology PANTHER and STRING database analyses highlighted associations of several genes and proteins associated with diabetic retinopathy with adaptive immune response, valyl-TRNA aminoacylation, complement activation, and immune system processes. Our analyses highlight potential transcriptomic and proteomic biomarkers for DR and emphasize the association of known aspects of immune response, the complement system, advanced glycosylation end-product formation, and specific receptor and mitochondrial function with DR pathophysiology. These findings may suggest pathways for future research into novel diagnostic and therapeutic strategies for DR.

Published
2024
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50. Reliability and accuracy of artificial intelligence ChatGPT in providing information on ophthalmic diseases and management to patients.

Author

Cappellani F, Card KR, Shields CL, Pulido JS, and Haller JA

Subjects
Humans, Reproducibility of Results, Surveys and Questionnaires, Patient Education as Topic, Artificial Intelligence, Eye Diseases diagnosis, Eye Diseases therapy, Ophthalmology
Abstract

Purpose: To assess the accuracy of ophthalmic information provided by an artificial intelligence chatbot (ChatGPT)., Methods: Five diseases from 8 subspecialties of Ophthalmology were assessed by ChatGPT version 3.5. Three questions were asked to ChatGPT for each disease: what is x?; how is x diagnosed?; how is x treated? (x = name of the disease). Responses were graded by comparing them to the American Academy of Ophthalmology (AAO) guidelines for patients, with scores ranging from -3 (unvalidated and potentially harmful to a patient's health or well-being if they pursue such a suggestion) to 2 (correct and complete)., Main Outcomes: Accuracy of responses from ChatGPT in response to prompts related to ophthalmic health information in the form of scores on a scale from -3 to 2., Results: Of the 120 questions, 93 (77.5%) scored ≥ 1. 27. (22.5%) scored ≤ -1; among these, 9 (7.5%) obtained a score of -3. The overall median score amongst all subspecialties was 2 for the question "What is x", 1.5 for "How is x diagnosed", and 1 for "How is x treated", though this did not achieve significance by Kruskal-Wallis testing., Conclusions: Despite the positive scores, ChatGPT on its own still provides incomplete, incorrect, and potentially harmful information about common ophthalmic conditions, defined as the recommendation of invasive procedures or other interventions with potential for adverse sequelae which are not supported by the AAO for the disease in question. ChatGPT may be a valuable adjunct to patient education, but currently, it is not sufficient without concomitant human medical supervision., (© 2024. The Author(s).)

Published
2024
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