Objective: To describe clinical results from a pilot study of a novel glaucoma surgical device.
Design: Prospective interventional case series.
Participants: Thirty-seven adult Hispanic and Caucasian patients (17 male, 20 female) with uncontrolled open-angle glaucoma (OAG) in one or both eyes with or without previous surgery or laser treatment were recruited from a clinical practice in Tijuana, Mexico.
Intervention: Surgery was performed with the Trabectome (NeoMedix Corp., San Juan Capistrano, CA) in one eye of each patient.
Main outcome measures: Goldmann applanation intraocular pressures and Snellen visual acuities were measured before and after surgery. Intraoperative and postoperative adverse events were tabulated, and numbers of preoperative and postoperative adjunctive medications were compared before and after surgery.
Results: Preoperative pressures after 1 week of medication washout averaged 28.2+/-4.4 mmHg (n = 37). Only 3 patients were not using topical medications preoperatively. Follow-up ranged between 3 months (n = 37) and 13 months (n = 11). Mean postoperative IOPs were 18.4+/-10.9 mmHg (n = 37) at 1 day, 17.5+/-5.9 mmHg (n = 37) at 1 week, 17.4+/-3.5 mmHg (n = 25) at 6 months, and 16.3+/-2.0 mmHg (n = 15) at 12 months. Visions returned to within 2 lines of preoperative levels and remained stable in all patients beyond 3 weeks postoperatively except one, not sutured at surgery, who had a late hyphema probably associated with corneal wound gaping after accidental blunt trauma. The number of adjunctive medications decreased from 1.2+/-0.6 among preoperative patients on medications (n = 34) to 0.4+/-0.6 among all patients at 6 months (n = 25). Blood reflux occurred in all eyes on instrument withdrawal after angle surgery and was present at day 1 in 22 eyes (59%) with clearing by slit-lamp examination at a mean of 6.4+/-4.1 days postoperatively.
Conclusions: The Trabectome seems to offer a safe and effective method of lowering IOP in OAG.