Abstract
Abstract: :
Purpose: To describe the incidence of complications that occurred both intraoperatively and within the first month after trabeculectomy surgery on previously untreated eyes, and to evaluate risk factors for the more frequent complications. Methods: Within the context of a randomized controlled clinical trial, 525 trabeculectomies were performed on previously untreated eyes of 300 patients randomized to initial surgery for newly-diagnosed open-angle glaucoma OAG). Study investigators and community ophthalmologists at 14 clinical centers performed the surgeries. Complications noted during surgery and within the first month after surgery were reported on data forms. Results: An operative complication was reported for 13.5% (72) of the 525 eyes undergoing trabeculectomy. The most frequent complication (7.1%, n=37) was intraoperative bleeding within the anterior chamber (AC). All other operative complications occurred in less than 1.0% of surgeries. No expulsive choroidal hemorrhages occurred. During the first postoperative month, with information on 517 of the 525 surgeries, five complications were reported with frequencies exceeding 10%: shallow or flat AC (14.2%), encapsulated bleb (11.9%), ptosis (11.9%), serous choroidal detachment (11.3%), and AC bleeding or hyphema (10.5%). No endophthalmitis was observed. A detailed accounting of all reported complications will be provided. The incidence of ptosis was significantly higher among African Americans (19.0% vs. 7.3%, p=0.0001), whereas the incidence of wound leak and corneal problems (dellen) was greater among whites and others vs. African Americans (7.0% vs. 2.5% and 8.1% vs. 1.5%, respectively). Conclusion: Performing trabeculectomy surgery on previously untreated eyes of patients with newly-diagnosed OAG resulted in an expected spectrum of mostly minor, non vision threatening complications during the operation and first postoperative month. These data provide estimates of incidence that will better inform patients of the risk of perioperative complications, and alert surgeons to the risk factors for specific complications.
Keywords: 353 clinical (human) or epidemiologic studies: outcomes/complications • 536 quality of life