Cutting Edge Glaucoma - Issue 2

32 • CUTTING EDGE - GLAUCOMA Table 1: Patient demographics and baseline characteristics (mITT population). Demographics/characteristics Implant alone N = 106 Phaco + implant N = 79 Total N = 185 Mean age, years (SD) 68.3 (11.7) 76.5 (6.1) 71.8 (10.5) Sex, n (%) Female 55 (51.9) 40 (50.6) 95 (51.4) Male 51 (48.1) 39 (49.4) 90 (48.6) Race, n (%) White 103 (97.2) 75 (94.9) 178 (96.2) Black/African-American 2 (1.9) 1 (1.3) 3 (1.6) Asian 1 (0.9) 3 (3.8) 4 (2.2) Preoperative IOP, mmHg (SD) a 21.7 (3.8) 21.0 (3.4) 21.4 (3.6) Mean IOP-lowering medications, n (SD) a 2.7 (0.9) 2.5 (0.9) 2.7 (0.9) Use of IOP-lowering agents, n (%) a,b β-blockers 94 (82.5) 66 (75.0) 160 (79.2) Carbonic anhydrase inhibitors 82 (71.9) 51 (58.0) 133 (65.8) Parasympathomimetics 1 (0.9) 3 (3.4) 4 (2.0) Prostaglandin analogs 102 (89.5) 83 (94.3) 185 (91.6) Sympathomimetics 40 (35.1) 26 (29.5) 66 (32.7) Pseudophakic, n (%) 25 (23.6) c 0 25 (13.5) Average visual field mean deviation, dB (SD) a − 7.9 (8.6) − 8.0 (9.2) − 8.0 (8.9) IOP , intraocular pressure; mITT , modified intent-to-treat; phaco , phacoemulsification with intraocular lens placement; SD , standard deviation a Based on the number of eyes in the implant alone group ( N = 114), the phaco + implant group ( N = 88), and the total population ( N = 202) b Total exceeds 100% in each cell because several patients/eyes were using multiple IOP-lowering agents c The remaining eyes were phakic ( n = 80) or aphakic ( n = 1) included only one eye per patient. Results of both sensitivity analyses were similar to the effective- ness outcomes described in the above paragraphs. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months in the mITT population (Figs. 3 and 4). Looking at specific IOP targets achieved at 12 and 24 months, 55.6 ( n = 99/178) and 48.4% ( n = 78/161) of eyes with available data achieved IOP reductions ≥ 30% from preoperative medicated baseline at 12 and 24 months, respectively (Fig. 5). In addi- tion, the proportion of eyes achieving IOP ≤ 18, ≤ 15, and ≤ 12 mmHg was 83.7, 60.7, and 27.5% at 12 months, and 85.1, 62.7, and 24.2% at 24 months, respectively (Fig. 6). Remarkably, 51.1 ( n = 91/178) and 44.7% ( n = 72/161) of eyes with available data at 12 and 24 months were medication-free (topical), with a mean IOP (SD) of 13.8 (3.1) and 14.3 (3.1) mmHg, respectively (Table 3). Among the medication-free eyes, 79/91 (86.8%) and 59/72 (81.9%) achieved clinical success at 12 and 24 months, respectively.