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Titolo:
Submacular surgery trials randomized pilot trial of laser photocoagulationversus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: I. Ophthalmic outcomes - Submacular surgery trials pilot study report number 1
Autore:
Bressler, NM; Bressler, SB; Hawkins, BS; Marsh, MJ; Sternberg, P; Thomas, MA; de Juan, E; Campochiaro, PA; Haller, JA; Schachat, P; Belt, J; Cain, T; Hartnett, M; Hawse, P; Herring, M; Imach, J; McDonald, J; Porter, T; Holekamp, NM; Meredith, TA; Barts, B; Breeding, L; Dahl, J; Gualdoni, JL; Hoffmeyer, G; Nobel, V; Ort, E; Capone, A; Lim, JI; Brown, JM; Gibbs, DK; Gilman, J; Johnson, J; Swords, R; Waldron, RG; Williams, GA; Garretson, BR; Cumming, KL; Medina, T; Mitchell, B; Regan, V; Streasick, P; Szydlowski, LD; Zajechowski, M; Toth, CA; Jaffe, GJ; Anderson, MM; Hawks, TJ; Heinis, R; Schirmer, R; Singerman, LJ; Rice, TA; Pendergast, SD; DuBois, J; Ilc, MA; Knight, D; Lichterman, SE; Tilocco, KA; Bergren, RL; Campbell, A; Sedory, K; Steinberg, D; Vagstad, G; Wellman, L; Wilcox, L; Lewis, H; Conway, J; Holody, LJ; Vargo, PJ; McDonald, HR; Johnson, RN; DiAngelo, M; Rozenfeld, I; Uy, J; Wild, S; Wood, P; Lambert, HM; Miller, P; Shigley, J; Brucker, AJ; Dupont, J; Lurcott, J; Weeney, L; Wood, WJ; McDowell, LC; Oldroyd, M; Slade, E; Wolfe, JL; Lopez, PF; Nichols, T; Walonker, FA; Freeman, WR; Clark, T; Ochabski, R; Ramirez, B; Wilson, M; Hammer, ME; Malenfant, WJ; Rollins, J; Traynom, J; Bressler, NM; Childs, DA; Felicetti, IL; Orr, PR; Staflin, P; Bass, EB; Hawkins, BS; Casper, RG; Dong, LM; Grubb, SC; Kiah, TR; Lassiter, LA; Marsh, MJ; McCaffrey, LD; Miskala, PH; Newhouse, MM; Prusakowski, NA; Smith, DK; Mangione, CM; Rubin, GS; Bressler, SB; Alexander, J; Manos, KS; Mills, I; Philips, DA; Strozykowski, RW; Tian, Y; Orr, PR; Gualdoni, JB; Hartnett, M; Hawse, P; Cotch, MF; Hillis, AI; Abrams, GW; Connett, JE; Grady, C; Harrison, E; Jampol, LM; Bressler, NM; Alexander, J; Hawkins, BS; Maguire, MG; Bressler, SB; Fine, SL; Green, WR; Brucker, AJ; de Juan, E; Lambert, HM; Lopez, PF; Sternberg, P; Thomas, MA; Bressler, NM; Bass, EB; Bressler, SB; Cotch, MF; Grossniklaus, HE; Haller, JA; Hawkins, BS; Holton, JL; Mangione, CM; Orr, PR; Schwartz, SD; Sipperley, JO; Sternberg, P; Thomas, MA; Williams, GA;
Indirizzi:
Barnes Retina Inst, St Louis, MO USA Barnes Retina Inst St Louis MO USABarnes Retina Inst, St Louis, MO USA Emory Univ, Ctr Eye, Atlanta, GA 30322 USA Emory Univ Atlanta GA USA 30322 mory Univ, Ctr Eye, Atlanta, GA 30322 USA Assoc Retinal Consultants, Royal Oak, MI USA Assoc Retinal Consultants Royal Oak MI USA onsultants, Royal Oak, MI USA Duke Univ, Med Ctr, Dept Ophthalmol, Durham, NC 27710 USA Duke Univ Durham NC USA 27710 Ctr, Dept Ophthalmol, Durham, NC 27710 USA Retina Associates Cleveland, Cleveland, OH USA Retina Associates Cleveland Cleveland OH USA leveland, Cleveland, OH USA Retina Vitreous Consultants, Pittsburgh, PA USA Retina Vitreous Consultants Pittsburgh PA USA ltants, Pittsburgh, PA USA Cleveland Clin Fdn, Cole Eye Inst, Cleveland, OH 44195 USA Cleveland Clin Fdn Cleveland OH USA 44195 e Inst, Cleveland, OH 44195 USA Retina & Vitreous Texas, Houston, TX USA Retina & Vitreous Texas Houston TX USA & Vitreous Texas, Houston, TX USA Scheie Eye Inst, Philadelphia, PA USA Scheie Eye Inst Philadelphia PA USA cheie Eye Inst, Philadelphia, PA USA Retina & Vitreous Associates Kentucky, Lexington, KY USA Retina & VitreousAssociates Kentucky Lexington KY USA Lexington, KY USA Doheny Eye Inst, Los Angeles, CA 90033 USA Doheny Eye Inst Los Angeles CAUSA 90033 Inst, Los Angeles, CA 90033 USA Shiley Eye Ctr, San Diego, CA USA Shiley Eye Ctr San Diego CA USAShiley Eye Ctr, San Diego, CA USA Retina Associates Florida, Tampa, FL USA Retina Associates Florida Tampa FL USA Associates Florida, Tampa, FL USA Wilmer Ophthalmol Inst, Chairmans Off, Retinal Vasc Ctr, Baltimore, MD USAWilmer Ophthalmol Inst Baltimore MD USA inal Vasc Ctr, Baltimore, MD USA Wilmer Ophthalmol Inst, Coordinating Ctr, Baltimore, MD USA Wilmer Ophthalmol Inst Baltimore MD USA rdinating Ctr, Baltimore, MD USA Wilmer Ophthalmol Inst, Wilmer Photograph Reading Ctr, Baltimore, MD USA Wilmer Ophthalmol Inst Baltimore MD USA h Reading Ctr, Baltimore, MD USA NEI, NIH, Bethesda, MD 20892 USA NEI Bethesda MD USA 20892NEI, NIH, Bethesda, MD 20892 USA
Titolo Testata:
AMERICAN JOURNAL OF OPHTHALMOLOGY
fascicolo: 4, volume: 130, anno: 2000,
pagine: 387 - 407
SICI:
0002-9394(200010)130:4<387:SSTRPT>2.0.ZU;2-5
Fonte:
ISI
Lingua:
ENG
Soggetto:
SURGICAL REMOVAL; SUBFOVEAL NEOVASCULARIZATION; MEMBRANES; MANAGEMENT;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
25
Recensione:
Indirizzi per estratti:
Indirizzo: Hawkins, BS Submacular Surg Trials Coordinating Ctr, 550 N Broadway,9th Floor, Baltimore, MD 21205 USA Submacular Surg Trials Coordinating Ctr 550 N Broadway,9th Floor Baltimore MD USA 21205
Citazione:
N.M. Bressler et al., "Submacular surgery trials randomized pilot trial of laser photocoagulationversus surgery for recurrent choroidal neovascularization secondary to age-related macular degeneration: I. Ophthalmic outcomes - Submacular surgery trials pilot study report number 1", AM J OPHTH, 130(4), 2000, pp. 387-407

Abstract

PURPOSE: To report complications and changes in vision during 2 years of follow-up of patients with age-related macular degeneration assigned randomly to surgical removal or to laser photocoagulation of subfoveal recurrent neovascular lesions in a pilot trial designed to test methods, to refine estimates of outcome rates, and to project patient accrual rates for a larger multicenter randomized trial to evaluate submacular surgery. PATIENTS AND METHODS: Eligible patients with previous laser photocoagulation of extrafoveal or juxtafoveal choroidal neovascularization secondary to age-related macular degeneration were enrolled at 15 collaborating clinicalcenters. Assignments to treatment arm were made by personnel at a central coordinating center. Adherence to eligibility criteria and treatment assignment was assessed centrally at a photograph reading center. Patients were examined at 3, 6, 12, and 24 months after treatment for data collection purposes, Outcome measures reported include treatment complications, adverse events, requirements for additional treatment, and 2-year changes in visual acuity from baseline. RESULTS: Of 70 patients enrolled, 36 were assigned to laser photocoagulation and 34 to submacular surgery; all were treated as assigned. One patient in each group died before the 2-year examination. Visual acuity was measured at the 2-year examination for 31 of the surviving patients (89%) in the laser arm and for 28 of the surviving patients (85%) in the surgery arm. The2-year measurements for 36 of the 59 patients (61%) were made by an examiner masked to treatment assignment and to the identity of the study eye. Improvements and losses of visual acuity were observed in both treatment arms;20 of 31 study eyes (65%) in the laser arm and 14 of 28 study eyes (50%) in the surgery arm had visual acuity 2 years after enrollment that was better than or no more than 1 line worse than the baseline level. Changes in visual acuity and the size of the central macular lesions from baseline to the2-year examination were similar in the treatment arms. Few serious complications were observed in either arm at the time of initial treatment; serious adverse events were rare. During follow-up, 11 laser-treated eyes and 18 surgically treated eyes had additional intraocular procedures. CONCLUSIONS: The data from this pilot trial suggest no reason to prefer submacular surgery over laser photocoagulation for treatment of patients withage-related macular degeneration who have lesions similar to those studiedin this pilot trial. Any clinical trial designed to compare submacular surgery with laser photocoagulation in eyes with age-related macular degeneration and subfoveal recurrent neovascular lesions must enroll several hundredpatients in order to reach a statistically valid conclusion regarding differences between these two methods of treatment with respect to either changes in visual acuity or complication rates. (C) 2000 by Elsevier Science Inc. All rights reserved.

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Documento generato il 18/09/20 alle ore 10:54:15