Abstract
Purpose: :
Evaluate the intermediate to long-term clinical outcomes of the Ex-PRESS glaucoma filtration device.
Methods: :
Retrospective study of 45 consecutive eyes of 34 patients that received an Ex-PRESS glaucoma filtration device at one institution over a 6 year time period with at least 2 years of follow-up. Thirty eyes received the Ex-PRESS alone and 15 combined with phacoemulsification surgery. Outcome variables were intraocular pressure (IOP), number of anti-glaucoma medications, best corrected visual acuity (BCVA), visual field (VF)/ cup-to-disk ratio (CDR) progression, long term complications, and additional glaucoma procedures. Success was denoted by an IOP between 4 and 18mmHg with or without glaucoma medications and without further invasive glaucoma surgery or laser trabeculoplasty at the last follow-up visit.
Results: :
The patients were followed for an average of 46.4 ± 14.3 (range 24 to 72) months. Average preoperative IOP was 21.7±6.61 mmHg and average preoperative number of anti-glaucoma medications was 3.58±0.75. The IOP was 12.6±5.5, 12.0±4.95, 11.4±5.4, 11.7±5.37, 11.7±4.8 and 11±4.9mmHg at 1, 2, 3, 4, 5 and 6 years of follow-up respectively. The number of anti-glaucoma medications was 1.02±1.5, 1.14±1.5, 1.24±1.6, 1.23±1.5, 1.59±1.7 and 0.25±0.5 at those same time points respectively. There was no significant change in BCVA during the post-operative time period (p=0.4). CDR and VF rates of progression were estimated to be 0.00306 (p= 0.002) and 0.0345 (p= 0.0004) respectively. Post-operative complications were observed in nine (20%) eyes: hypotony (IOP<6mmHg) (7 eyes; 15.5%), corneal decompensation (2 eyes; 4.4%), choroidal detachment (1 eye; 2.2%), and Ex-PRESS shunt dislocation (1 eye; 2.2%). Out of all the complications, only corneal decompensation had a significant negative long-term effect on BCVA. Twenty-one (46.6%) eyes required further interventions after the initial glaucoma surgery: argon laser suture lysis (14 eyes; 31.1%), YAG laser to shunt tip (5 eyes; 11.1%), compression suture (1 eye; 2.2%), bleb needling (9 eyes; 20%), replacement of an Ex-PRESS shunt (1 eye; 2.2%) and other glaucoma surgery (2 eyes; 4.4%). The overall success rate was 82.2% at the last follow-up visit.
Conclusions: :
The Ex-PRESS glaucoma filtration device is clinically safe and effective, maintaining a long term reduction in IOP and number of anti-glaucoma medications, with minimal progression in visual field and cup-to-disk ratio.
Keywords: clinical (human) or epidemiologic studies: outcomes/complications