Clinical Results with the Trabectome for Treatment of Open-Angle Glaucoma
Received 25 October 2004; accepted 9 December 2004. published online 09 May 2005.
Refers to erratum:
Clinical Results With the Trabectome for Treatment of Open-angle Glaucoma: Erratum, Incorrect Visual Acuity
Ophthalmology
September 2005 (Vol. 112, Issue 9, Page 1540) Full Text |
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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.
1Doheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California.
Reprint requests to Don Minckler, Doheny Eye Institute, University of Southern California Keck School of Medicine, Department of Ophthalmology, 1450 San Pablo Street, Los Angeles, CA 90033-4666.
Manuscript no. 2004-224.
Supported in part by the National Institutes of Health, Bethesda, Maryland (grant nos.: EY03040, EY015037); by an unrestricted grant from Research to Prevent Blindness, New York, New York; and by NeoMedix Corp., San Juan Capistrano, California.
Dr Baerveldt is one of the inventors of the Trabectome and has a proprietary interest in the device. NeoMedix Corp. has exclusive rights to the patent and provided the device for the surgeries reported in this series.
ABSTRACT