Purpose: To describe the preoperative and postoperative motility disturbances encountered in the Tube Versus Trabeculectomy (TVT) Study during the first year of follow-up.
Design: Multicenter randomized clinical trial.
Methods: settings: Seventeen clinical centers. population: Patients 18 to 85 years old who had previous trabeculectomy and/or cataract surgery and uncontrolled glaucoma with intraocular pressure > or =18 mm Hg and < or =40 mm Hg on maximum tolerated medical therapy. interventions: 350-mm(2) Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). main outcome measures: Preoperative and postoperative evaluation of ocular motility and diplopia.
Results: Motility disturbances were detected in 55 patients (28%) at baseline. New-onset persistent diplopia was reported in 5 patients (5%) in the tube group and no patients in the trabeculectomy group at 1 year (P = .06). A new postoperative motility disturbance developed or worsened in 7 patients (9.9%) in the tube group and no patients in the trabeculectomy group during the first year of follow-up (P = .005). Postoperative motility disturbances were also associated with increasing age (P < .001) and right eye surgery (P = .044).
Conclusions: Preoperative motility disturbances were common among patients in the TVT Study. New postoperative motility disturbances were more frequent following tube shunt surgery than trabeculectomy with MMC after 1 year of follow-up.