Abstract
Purpose: :
The purpose of this study is a short term safety and efficacy evaluation of the Ex-PRESS P50 new model for the surgical treatment of POAG and refractory Glaucoma. Previous studies show that the Ex-PRESS is safe and effective in the treatment of POAG versus trabeculectomy (1). The Ex-PRESS new model P50 has been developed with minor modifications, and consists of a 50 micron internal lumen size and a back plate with a vertical split to direct flow posteriorly.
Methods: :
A single surgeon, retrospective, non-randomized study was performed at the Dean McGee Eye Institute, University of Oklahoma. Twenty-nine (29) subjects age 62.6 ± 13.4 (mean ± SD) with uncontrolled POAG, implanted with Ex-PRESS P50 model under a scleral flap, were reviewed. The follow up period was 2.31 ± 0.97 months (mean ± SD, range 1-3 months). The primary outcome included IOP control post operative medications and early post-operative complications.
Results: :
Eleven eyes (37.9%) had previous incisional surgery. The mean IOP was reduced from 30.5 +/-12.9 mmHg (mean Std) to 15.1 +/-9.6 mmHg, at 3 months. Medications were reduced from 3.4 +/-1.1 to 0.1 +/-0.2 (p<0.000) at 3 months (n=19). Complications included one patient with shallow/flat AC, one choroidal detachment, one vitrectomy from malignant glaucoma and two patients requiring needling. One patient required a CPC.
Conclusions: :
The P model was found to be safe and effective with a significant IOP and medications reduction, and with a small number of early post operative complications. Further follow-up and comparison to other available Ex-PRESS models is needed to better establish the efficacy of this device.References: P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with Ex-PRESS Miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma. 2007 Jan; 16:14-19
Keywords: clinical (human) or epidemiologic studies: outcomes/complications