THE ADVANCED GLAUCOMA INTERVENTION STUDY (AGIS) .1. STUDY DESIGN AND METHODS AND BASE-LINE CHARACTERISTICS OF STUDY PATIENTS
BROWN, RH; LYNCH, M; LEEF, D; GUNSBY, J; LOBER, K; MOORE, K; STEPKA, C; VELATHOMAS, A; GAASTERLAND, DE; COYLE, E; HUNDLEY, M; ASHBURN, F; VAYER, L; MICHELITSCH, K; LAUBER, S; BURT, E; RAE, A; WEBER, PA; DERICK, R; MCKINNEY, K; MOORE, D; BAKER, ND; KAPETANSKY, F; LEHMAN, D; GLOECKNER, B; SHARF, LJ; ROMANS, B; SATTERWHITE, Y; SIMMONS, L; HARBIN, TS; OZMENT, RR; WRIGHT, J; BUTLER, L; LASALLE, J; PERRY, M; NUMMERDOR, D; WILLE, L; ECKEL, A; SESSION, C; MARTIN, A; CYRLIN, MN; FAZIO, R; WILENSKY, JT; LINDENMUTH, K; NAIL, CA; RATHBONE, D; GATES, V; TADELMAN, M; SONTY, S; HOPKINS, G; HIGGINBOTHAM, EJ; SCHOLES, G; UVA, R; PAPPAS, L; FROHLICHSTEIN, D; FIENE, J; BERGSTROM, TJ; LICHTER, PR; STANDARDI, C; ZIEHMSCOTT, J; PAPIERNIAKDUBIEL, R; POLLACKRUNDLE, C; SKUTA, GL; BEESON, C; CREW, RP; KRUSEKE, L; MICHAEL, B; DEDERIAN, J; WICKER, D; AARON, D; BIRK, J; VANHECK, T; ALLEN, RC; NEWMAN, SA; NORLUND, JR; FENDLEY, CK; BERGHUIS, C; CHISHOLM, J; EVANS, C; MURPHY, E; SCHOTT, LJ; FORNILI, R; SCHWARTZ, AL; WEISS, H; WEHRLY, S; PAPPAS, S; ODEA, M; BOECKL, A; LOPEZ, P; CARMODY, K; MERCER, R; MONKS, V; VAWTER, K; WITOL, CV; CIRONE, M; GURLEY, J; REED, C; BROWNING, J; HARRIS, E; KATZ, LJ; SPAETH, GL; WILSON, RP; SAMUEL, F; BLOCK, A; KAO, S; BEKERSHOFF, CC; CAPRIOLI, J; MILLER, E; ROCHE, M; GROTTOLE, G; LEONE, A; TRESSLER, C; EDERER, F; SULLIVAN, EK; WAGNER, EL; ENTLER, G; BRADFORD, M; TOMLIN, KL; STINE, E; LINDBLAD, AS; KNOKE, JD; DENEKAS, M; SMITH, C; VOSS, T; MOWERY, RL; LYNCH, G; GOFF, F; FURBERG, CD; CONNETT, JE; DAVIS, MD; DUEKER, DK; GREEN, SB; HAMILTON, MP; SCHNEIDERMAN, MA; KASSOFF, A; MORRIS, M; PALMBERG, PF
Medical therapy has been the standard initial treatment for open-angle glaucoma. When some visual field has been lost and maximum tolerated and effective medical therapy does not succeed in controlling the disease, the patient is considered to have advanced glaucoma, and the first of a potential sequence of surgical treatments is usually indicated. Little is known about the long-term course and prognosis of advanced glaucoma or about the long-term effectiveness of sequential surgical treatments in controlling the disease and preventing vision loss and blindness. The Advanced Glaucoma Intervention Study was designed to study, in advanced glaucoma, the long-term clinical course and prognosis, and, in a randomized trial, the comparative outcomes of two sequences of surgical treatments. Toward these goals, 789 eyes in 591 patients were enrolled at 11 clinical centers between 1988 and 1992. Follow-up will continue until 1996. Eyes were randomly assigned to one of two sequences of surgical treatments. One sequence begins with argon laser trabeculoplasty (ALT), is followed by trabeculectomy, an incisional surgical filtering procedure, should ALT fail to control the disease, and by a second trabeculectomy should the first trabeculectomy fail. The other sequence begins with trabeculectomy, is followed by ALT should the trabeculectomy fail, and by a second trabeculectomy should ALT fail. The main outcome of interest is visual function (visual field and visual acuity). Other important outcomes are intraocular pressure, complications of surgery, time to treatment failure, and extent of need for additional medical therapy. We present in this paper the rationale, objectives, design and methods of the study, and the baseline characteristics of study patients and eyes. $$:
ISI:A1994PA96900006
ISSN: 0197-2456
CID: 103773
Effect of varying drop size on the efficacy and safety of a topical beta blocker
Charap, A D; Shin, D H; Petursson, G; Cinotti, D; Wortham, E 4th; Brown, R H; Silverstone, D E; Atkins, J M; Eto, C Y; Lue, J C
We studied the effects on efficacy and safety of varying the drop size of a topical solution of levobunolol 0.5%. In a double-masked, crossover acute study, we administered a single drop of either 35 microL of vehicle, or 20, 35, or 50 microL of levobunolol one hour before the subjects began a ten-minute treadmill challenge electrocardiogram. After exercise the mean heart rate was 111 beats per minute (bpm) in the vehicle group and 102 to 103 bpm in the three levobunolol groups, which were significantly different from the control group but not from each other. In a randomized double-masked, parallel, chronic study, 117 patients with elevated intraocular pressure (IOP) instilled one of the three drop sizes of levobunolol twice daily for three months. Mean decreases in IOP ranged from 5.1 to 6.0 mmHg in the three groups, not significantly different from each other in mean IOP, heart rate, or blood pressure. We conclude that drop size in the range tested had no clinically significant effect on either efficacy or safety of a beta blocker such as levobunolol.
PMID: 2683937
ISSN: 0003-4886
CID: 1736562