Cutting Edge Glaucoma - Issue 2

38 • CUTTING EDGE - GLAUCOMA − 0.23 [0.24]), compared with the implant alone group (− 0.02 [0.19] and 0.01 [0.21]), respec- tively. Changes in mean central corneal thickness (SD) were not statistically significant at 12 and 24 months. The change from baseline in average visual field mean deviation was not statistically significant at 24 months (− 1.0 [8.3]; P = 0.138). Discussion This prospective, 24-month, non-randomized, open-label, multicenter study conducted in typical clinical settings assessed the long-term effectiveness and safety of the gelatin implant in patients with POAG uncontrolled on topical IOP-lowering medications. Mean IOP was reduced from 21.4 (3.6) (medicated baseline) to 14.9 (4.5) mmHg at month 12 and 15.2 (4.2) mmHg at month 24; the mean IOP-lowering medication count decreased from 2.7 (0.9) at baseline to 0.9 (1.1) at month 12 and 1.1 (1.2) at month 24. Similar results were observed in both treatment groups at all postoperative visits up to 24 months ( P > 0.4, between-group comparisons). In addition, no differences in outcomes were noted at 24 months in pseudophakic eyes that received the implant Table 4: Number (%) of eyes that underwent 1, 2, 3, or > 3 needling procedures (mITT population) a . Number of needling procedures up to month 24 Implant alone N = 50/114 Number of eyes, n (%) Phaco + implant N = 33/88 Total N = 83/202 1 35 (70.0) 21 (63.6) 56 (67.5) 2 8 (16.0) 6 (18.2) 14 (16.9) 3 3 (6.0) 5 (15.2) 8 (9.6) > 3 4 (8.0) 1 (3.0) 5 (6.0) mITT , modified intent-to-treat; phaco , phacoemulsificationwith intraocular lens placement a Among study eyes that underwent needling at any time point Table 5: Summary of intraoperative complications (safety population). Intraoperative complications Implant alone N = 120 Phaco + implant N = 98 Total N = 218 Total 3 (2.5) 7 (7.1) 10 (4.6) Anterior chamber bleeding a 1 (0.8) 5 (5.1) 6 (2.8) Iris damage 0 1 (1.0) 1 (0.5) Subconjunctival hemorrhage 1 (0.8) 0 1 (0.5) Vitreous in the pupil plane (aphakic eye) b 1 (0.8) 0 1 (0.5) Zonular disinsertion c 0 1 (1.0) 1 (0.5) phaco , phacoemulsificationwith intraocular lens placement a Characterized as excessive in five eyes b Underwent vitrectomy c Phacodonesis had been recorded prior to the surgery