Perioperative Complications of Trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS) HENRY D. JAMPEL, MD, MHS, DAVID C. MUSCH, PHD, MPH, BRENDA W. GILLESPIE, PHD, PAUL R. LICHTER, MD, MARTHA M. WRIGHT, MD, KENNETH E. GUIRE, MS, AND THE COLLABORATIVE INITIAL GLAUCOMA TREATMENT STUDY GROUP ● PURPOSE: To describe the incidence of, and risk factors for, surgical complications reported during and within the first post-operative month after trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). ● DESIGN: Review of prospectively collected data from a multicenter, randomized clinical trial. ● METHODS: Complications were tabulated for the 300 CIGTS patients randomized to surgery. Logistic regres- sion analyses were used to identify risk factors for complications. ● RESULTS: Among the 300 patients randomized to initial surgery, 465 trabeculectomies were performed. Intraoperative complications were reported in 55 eyes (12%). The most frequent reported complications were anterior chamber bleeding during surgery (37 eyes, 8%) and conjunctival buttonhole (five eyes, 1%). Early post- operative complications were reported in 232 eyes (50%). Complications with a frequency over 10% in- cluded shallow or flat anterior chamber (62 eyes, 13%), encapsulated bleb (56 eyes, 12%), ptosis (55 eyes, 12%), serous choroidal detachment (52 eyes, 11%), and ante- rior chamber bleeding or hyphema (48 eyes, 10%). There were three localized suprachoroidal hemorrhages (0.7%) and no cases of endophthalmitis. Older patients were more likely to experience serous choroidal detach- ment, new anterior or posterior synechiae, and wound leak. Blacks were less likely to experience anterior chamber bleeding, but more likely to experience post- operative ptosis. The number of subjects experiencing bilateral complications was higher than that which would have been predicted by chance alone. ● CONCLUSIONS: The incidence of transient and self- limiting complications was high in the perioperative period, but we observed few complications with the potential to cause severe sustained vision loss in this group of previously untreated eyes. (Am J Ophthalmol 2005;140:16 –22. © 2005 by Elsevier Inc. All rights reserved.) T HE COLLABORATIVE INITIAL GLAUCOMA TREAT- ment Study (CIGTS) is a multicenter, randomized, clinical trial comparing trabeculectomy versus top- ical medications as the initial treatment for glaucoma. Details of the study design and characteristics of the subjects have been previously reported, 1 and interim re- sults from the study regarding visual and quality of life outcomes have been published. 2,3 The interim results suggested that patients initially treated with surgery or medication differed little in terms of visual function or quality of life 3 to 5 years after surgery, but that the patients who underwent surgery first had more ocular symptoms during the first 2 post-operative years. Given the relative equivalence of treating with medi- cine or surgery first, the risk/benefit ratio of initial surgery versus initial medications might be largely determined by the incidence and severity of complications after glaucoma surgery. Furthermore, patient and surgeon apprehension about trabeculectomy is in part caused by the fear of sight-threatening surgical complications. The CIGTS Accepted for publication Feb 1, 2005. From the Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland (H.D.J.); Departments of Ophthalmology and Visual Sciences (D.C.M., P.R.L.), Epidemiology (D.C.M.), and Biostatistics (B.W.G., K.E.G.), University of Michigan, Ann Arbor, Michigan; and Department of Ophthalmology, University of Minnesota, Minneapolis, Minnesota (M.M.W.). Members of the CIGTS Study Group are listed in the Appendix to Musch DC et al. Ophthalmology 1999;106:653– 662. Dr. Jampel is the recipient of a Research to Prevent Blindness Physician-Scientist Award. Supported by National Institutes of Health, Bethesda, Maryland, grants EY09100, EY09140, EY09141, EY09142, EY09143, EY09144, EY09145, EY09148, EY09149, EY09150, and EY09639. Inquiries to Henry D. Jampel, MD, MHS, Johns Hopkins Hospital, Wilmer Ophthalmological Institute, Maumenee B-110, 600 North Wolfe Street, Baltimore, MD 21287-9205; fax: (410) 502-7493; e-mail: hjampel@jhmi.edu © 2005 BY ELSEVIER INC.ALL RIGHTS RESERVED. 16 0002-9394/05/$30.00 doi:10.1016/j.ajo.2005.02.013