Cutting Edge Glaucoma - Issue 2

TWO-YEAR RESULTS OF A MULTICENTER STUDY OF THE AB INTERNO GELATIN IMPLANT IN MEDICALLY... • 31  At 24 months, outcomes were also similar in pseudophakic eyes that received the implant alone (IOP reduction, − 8.4 mmHg; reduction in medication number, − 1.5; n = 15 in the mITT population) versus the overall implant alone group and the phaco + implant group. The outcomes also appeared similar between phakic ( n = 80) and pseudophakic ( n = 25) eyes that received the implant alone, although no statistical comparisons were made between these groups. Because 19 patients had both eyes implanted, two sensitivity analyses were conducted. One used a random effect model to adjust for correlation between those eyes [21], while the other ocedure ’ s effect on IOP, a formal calcula- as not performed. The study was remote- risk-based monitoring approach with one d of the study. Although an interim anal- as performed as planned and interim data the 12-month visit; 174/218 (79.8%) completed the 24-month visit, while 44/218 (20.2%) discontinued the study (Fig. 1 ). No eye was withdrawn due to complications from cataract surgery. Data were comparable in the mITT population, with 182/202 (90.1%) and 161/202 (79.7%) eyes completing the Enrolled a ( N = 200 patients; 219 eyes) Entered the study ( N = 217 patients; 240 eyes) Safety population b ( N = 199 patients; 218 eyes) mITT population c ( N = 185 patients; 202 eyes) Implant only ( N = 112 patients; 120 eyes) Phaco + implant ( N = 87 patients; 98 eyes) Discontinuations ( N = 29, 24.2%) due to: Conversion ( n = 12; 10.0%) Lost to follow-up ( n = 7; 5.8%) Death ( n = 2; 1.7%) Implant malposition ( n = 1; 0.8%) Consent withdrawal ( n = 1; 0.8%) Other d ( n = 6; 5.0%) Discontinuations ( N = 15, 15.3%) due to: Conversion ( n = 1; 1.0%) Lost to follow-up ( n = 1; 1.0%) Death ( n = 3; 3.1%) Explantation ( n = 1; 1.0%) Other d ( n = 9; 9.2%) Completed the 24-month visit ( N = 91 eyes; 75.8%) Completed the 24-month visit ( N = 83 eyes; 84.7%) Completed the 12-month visit ( N = 103 eyes; 85.8%) Completed the 12-month visit ( N = 94 eyes; 95.9%) on. mITT, ; Phaco, th ent. a ied mentation . b n implant lant, N = hat met the sion asons Fig. 1: Patient disposition. mITT , modified intent-to-treat; Phaco , phacoemulsification with intraocular lens placement. a Patients/eyes with verified informed consent documentation (incomplete consent documenta- tion, N = 21). b Enrolled and received an implant (did not receive an implant, N = 1). c All enrolled eyes that re- ceived an implant and met the IOP and IOP-lowering medication count inclusion criteria. d No specific reasons were recorded