Cutting Edge Glaucoma - Issue 2

TWO-YEAR RESULTS OF A MULTICENTER STUDY OF THE AB INTERNO GELATIN IMPLANT IN MEDICALLY... • 39  Table 6: Ocular adverse events reported throughout the 2-year study (safety population). Ocular adverse events, n (%) Total, N = 218 eyes Secondary surgical intervention 14 (6.4) Trabeculectomy 9 (4.1) XEN®45 gelatin stent 2 (0.9) iStent® 1 (0.5) Ex-Press® shunt 1 (0.5) SLT 1 (0.5) Hyphema a 10 (4.6) Device fracture 6 (2.8) IOP increase 6 (2.8) Study eye 5 (2.3) Fellow eye 1 (0.5) Hypotony b 5 (2.3) YAG capsulotomy 5 (2.3) Choroidal effusion c 4 (1.8) Conjunctival erosion 4 (1.8) Implant blockage by iris 3 (1.4) Eye pain 3 (1.4) Blepharitis 2 (0.9) Drug allergy 2 (0.9) Dysesthesia 2 (0.9) Iritis 2 (0.9) Retinal disorder d 2 (0.9) Shallow anterior chamber 2 (0.9) Subconjunctival hemorrhage 2 (0.9) Cataract aggravated 1 (0.5) Conjunctivitis 1 (0.5) Corneal epithelium defect 1 (0.5) Corneal infiltrates 1 (0.5) Device migration 1 (0.5) Endophthalmitis e 1 (0.5) Iris injury 1 (0.5) Keratitis, bacterial 1 (0.5) Macular edema 1 (0.5) Uveitic glaucoma f 1 (0.5) Visual field progression 1 (0.5) IOP , intraocular pressure; MMC , mitomycin C; SLT , selective laser trabeculoplasty; YAG , yttrium-aluminum-garnet a Self-resolved, lasting < 30 days b Definedas IOP<6mmHgpresentattwoconsecutivepostoperativevisits>30daysapart c Self-limiting, lasting > 30 days d Included central retinal vein occlusion (CRVO) with retinal hemorrhages and macular edema (IOP 14 mmHg), a serious AE reported at 24 months ( n = 1), and vitrectomy (IOP 16 mmHg; not further detailed) reported at 18 months ( n = 1) e Endophthalmitis was reported 15 months after implantation and treated successfully with anterior chamber wash, vitrectomy, and intravitreal antibiotics. No implant erosion or blebitis was documented on any visits f Same eye that had endophthalmitis