Abstract
Purpose: :
To present the outcomes in Trabectome™ alone versus Trabectome™ combined with phacoemulsification in patients of African decent.
Methods: :
A prospective, non-randomized, observational, comparative cohort study of 142 patients of African descent who underwent Trabectome™ surgery from 2006 to 2011 in multiple centers. The patients are stratified into the 2 groups of Trabectome™ alone versus Trabectome™ combined with cataract extraction by phacoemulsification. Inclusion criteria were open-angle glaucoma patients with uncontrolled intraocular pressure on maximum tolerated medical therapy with a 12-month postoperative follow up. The outcome measures are intraocular pressure (IOP), the number of glaucoma medications, and the occurrence of any secondary surgeries.
Results: :
All patients with Trabectome™ surgery included both alone or in combination with phacoemulsification (n=142) were evaluated at 12 months post-operatively. In the entire group, the IOP was reduced by 22%. The average preoperative and postoperative IOP decreased from 23.5±7.4 mmHg to 17.1±4.1 mmHg (p<0.01), respectively. The mean preoperative and postoperative number of glaucoma medication changed from 2.70±1.37 to 2.46±1.49 (p=0.32), respectively. Thus, the mean glaucoma medications were not statistically significantly reduced. In the subset of patients with Trabectome™ alone (n=82), the IOP was reduced by 28%. The average preoperative and postoperative IOP decreased from 26.3±7.1 mmHg to 17.9±4.6 mmHg (p<0.01), respectively. The mean preoperative and postoperative number of glaucoma medications changed from 3.09±1.32 to 3.04±1.08 (p=0.8), respectively. Thus, the mean glaucoma medications were not statistically significantly reduced. In the subset of patients with Trabectome™ combined with phacoemulsification (n=60), the IOP reduced by 15%. The average preoperative and postoperative IOP decreased from 9.6±6.1 mmHg to 16.1±3.2 mmHg (p<0.01), respectively. The mean preoperative and postoperative number of glaucoma medications changed from 2.17±1.28 to 1.83±1.63 (p=0.4), respectively. Thus, the mean glaucoma medications were not statistically significantly reduced. The percentages of secondary surgeries in the entire group, the Trabectome™ alone group, and the Trabectome™ combined with phacoemulsification group were 11%, 17%, and 3%, respectively (p<0.01).
Conclusions: :
The decrease in IOP is significant in each of the groups. There is no significant decrease in the number of glaucoma medications. The lowest rate of secondary surgeries occurs in Trabectome™ combined with phacoemulsification.
Keywords: clinical (human) or epidemiologic studies: outcomes/complications • intraocular pressure