Cutting Edge Glaucoma - Issue 2

TWO-YEAR RESULTS OF A MULTICENTER STUDY OF THE AB INTERNO GELATIN IMPLANT IN MEDICALLY... • 33  Needling In the mITT population, the overall needling rate was 41.1% ( n = 83/202), without statistically significant differences between the implant alone (43.9%; n = 50/114 eyes) and phaco + implant (37.5%; n = 33/88) groups at month 24 ( P > 0.5). The median needling rate was 33%. The mean (SD) and median numbers of needling procedures per eye at 24 months were 1.6 (1.1) and 1.0 in the overall population, with a range of 1 to 6. The majority of needled eyes ( n = 56/83; 67.5%) had one procedure (Table 4), and the mean time (SD) to the first needling was 152 (160) days (median, 90 days). In 74/83 (89.2%) cases, an antifibrotic agent (MMC, 5-FU, or other) was used during the procedure. The clinical success rate in needled eyes, as defined in the “Methods” section, was 59.2% at 12 months and 44.6% at 24 months. Safety Intraoperative complications were reported in 10 (4.6%) eyes, the most common being anterior chamber bleeding in 6 (2.8%) eyes (Table 5). A total of 65/218 (29.8%) eyes had one or more postoperative ocular AEs (Table 6); glaucoma-related SSI due to uncontrolled IOP ( n = 14/218; 6.4%—the most common being trabeculectomy) and hyphema ( n = 10/218; 4.6%) were most frequently reported (Table 6). Overall, 44/218 (20.2%) eyes had numeric hypotony (< 6 mmHg, self-resolved) within the first 2 postoperative weeks. Only 5/218, however, were recorded as AEs, all of which occurred within 1 week post-implantation and resolved by the 1-month visit without any intervention. No eyes had persistent hypotony, defined in the protocol as IOP < 6 mmHg at two consecutive postoperative visits > 30 days apart. Notably, there were no Table 2: Time and absolute dose of adjunctive antifibrotic therapy administered during surgery (mITT population). Implant alone ( N = 114) Phaco + implant ( N = 88) Total ( N = 202) Absolute dose (μg) 10, n (%) a 85 (74.6) 72 (81.8) 157 (77.7) 20, n (%) a 21 (18.4) 7 (8.0) 28 (13.9) > 20–40, n (%) a 7 (6.1) 4 (4.5) 11 (5.4) 60–80, n (%) a 1 (0.9) 3 (3.4) 4 (2.0) 500, n (%) b 0 2 (2.3) 2 (1.0) Time of administration Day before surgery 9 (7.9) 6 (6.8) 15 (7.4) Before implantation 100 (87.7) 69 (78.4) 169 (83.7) After implantation 0 4 (4.5) 4 (4.5) Unspecified (perioperative) 5 (4.4) 9 (10.2) 14 (6.9) mITT, modified intent-to-treat; phaco , phacoemulsification with intraocular lens placement a Mitomycin C b 5-Fluorouracil