INITIAL CLINICAL-EXPERIENCE WITH THE BAERVELDT IMPLANT IN COMPLICATEDGLAUCOMAS

Background: The Baerveldt glaucoma implant is an aqueous shunting devi ce with a large surface area that is installed through a conjunctival incision in one quadrant of the eye. This study presents the initial r esults of the first 13 patients who underwent Baerveldt implantation a s part of the Food and Drug Administration approval process. Methods: Thirteen patients with medically uncontrollable complicated glaucomas underwent one-stage implantation of either a 200- or 350-mm(2) Baervel dt implant without postoperative systemic antifibrosis therapy. Surgic al success was defined as intraocular pressure greater than or equal t o 6 and less than or equal to 21 mmHg without glaucoma reoperation or devastating complication. Results: Eight patients (62%) had successful surgical outcomes, with a mean followup of 17.3 +/- 7.0 months (+/- s tandard deviation) (range, 6-24 months). Seven (70%) of the ten patien ts with glaucomas associated with aphakia or pseudophakia had successf ul outcomes, whereas only one (50%) of the two patients with neovascul ar glaucomas had a successful outcome. One patient with glaucoma assoc iated with nanophthalmos and an unsuccessful filtering procedure had a failed outcome. The postoperative visual acuities remained within one line of the preoperative visual acuities or improved in 62% of the pa tients. The most frequent complications among all patients were transi ent serous choroidal effusion (23%) and hyphema (15%). Conclusion: Ini tial results of the Baerveldt implant generally are comparable with ot her implants. It is easier to install and requires less extensive conj unctival dissection than other large implants. Additional studies are needed to evaluate the effectiveness of the Baerveldt implant in affor ding long-term intraocular pressure control.