EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/892879
69 EW GLAUCOMA November 2017 performed in a region far away from the collector channels, there may be less efficacy from the procedure. Ike Ahmed, MD, pioneered the concept of targeting trabecular micro-bypass by determining intraoperatively at which clock hour the outflow into the episcleral veins is likely to be high- est. Once identifying the regions that appear to have the greatest amount of aqueous egress into episcleral veins, one may then place trabecular micro-by- pass stents in those areas. In order to investigate this approach, Kansal and colleagues retrospectively looked at their patients who either did or did not re- ceive targeted stents. While the evidence suggested that targeting did not make a difference, it is likely that additional prospective studies will investigate the matter further. EW Editors' note: Dr. Radcliffe has financial interests with Allergan and Glaukos. Contact information Radcliffe: drradcliffe@gmail.com in non-targeted (p=0.24). 70.2% (53.0–83.1) of targeted eyes achieved the primary outcome and 35.1% (18.6–60.0) of non-targeted (adjust- ed OR 4.4 [95% CI 1.4–13.7]). There was insufficient evidence to con- clude a difference in the percentage of patients achieving the secondary outcomes between groups. Conclusion: Targeted micro-bypass implantation was more likely than non-targeted to achieve IOP ≤21 mm Hg on less medication; no difference was identified for other success cri- teria. While regression adjusted for baseline characteristics, unmeasured confounders cannot be accounted for. Future studies should be ran- domized, prospective, and assess washed out IOP. Dr. Radcliffe: Since the beginning of the trabecular micro-bypass arrival, we have learned a fair bit about Schlemm's canal. The canal may not be contiguous for 360 degrees, and because of this, it is possible that if micro-bypass is validate new technology and aid in reimbursement decisions by payers. The data is very encouraging, with 76% of patients achieving a 20% IOP reduction, or about 6.4 mm Hg lower than baseline. While roughly one-third required a needling intervention, the safety profile was excellent, confirming the XEN 45 gel stent as an exciting new option for glaucoma treatment. Efficacy of two targeted versus non-targeted trabecular mi- cro-bypass stents: Preliminary investigation Vinay Kansal, BHSc, Matthew Schlenker, MD, Devesh Varma, MD Purpose: To compare the efficacy of targeted vs. non-targeted implanta- tion of two trabecular micro-bypass stents. Methods: Single-center, retrospective, investigational cohort study. 102 eyes, 72 patients with ≥2 months of follow-up that had micro-by- pass stent implantation at Trillium Health Partners (Mississauga, Cana- da) from January 2010 to July 2016. 72 eyes targeted implantation, 40 non-targeted. Primary outcome: IOP ≤21 mm Hg and on fewer IOP-low- ering medications on last follow-up vs. baseline. Secondary outcomes: 1) IOP≤18, no medications, and 2) ≥20% IOP reduction, no medication increase. Baseline characteristics were compared with Fisher's exact tests and Wilcoxon rank sum tests. Mixed effects model adjusted for baseline characteristics and account- ing for correlation between eyes was used to compare interventions. Results: Baseline characteristics were similar between groups with these exceptions: targeted group had high- er median IOP (16.0 vs. 15.0 mm Hg, p=0.03), and more IOP-reducing medications (3.2 vs. 2.6, p=0.01). Median follow-up was 13.2 months in targeted group and 13.9 months results, e.g., neovascular, congenital, or infantile, or uncontrolled IOP on maximum-tolerated medical thera- py), IOP ≥20 and ≤35 mm Hg, and visual field mean deviation ≤–3 dB were candidates. Primary outcomes: subjects (%) achieving ≥20% IOP reduction from baseline on the same or fewer medications, and mean IOP decrease from baseline at 12 months. Procedure-related complica- tions and ocular adverse events (AEs) were assessed at 12 months. Sensitiv- ity and subpopulation analyses were conducted. Results: 65 subjects were implanted (intent-to-treat population); 83% completed 12 months. At baseline, 85% of subjects had prior glaucoma procedures and mean medicated IOP was 25.1 mm Hg. At 12 months, 76% achieved ≥20% IOP reduction from baseline on the same or fewer medi- cations; mean IOP reduction was 6.4 mm Hg (95% CI: –4.0, –8.8). Results were similar with observed data (n=61). Mean medication count was 3.5 at baseline vs. 1.7 at 12 months. There were no intraoperative compli- cations. Most AEs were mild/moder- ate and transient, none unexpected. Hypotony (IOP <6 mm Hg) requiring no surgical intervention occurred in 25% of subjects. Needling was performed in 32%; 17/21 had no resulting complications. Conclusion: In subjects with refracto- ry glaucoma, placement of the gel stent using a minimally invasive ab interno approach lowered IOP and medication use. Dr. Radcliffe: Dr. Sheybani provides per- haps the freshest and timeliest data on the XEN 45 gel stent for the treatment of refractory glaucoma. This data is particularly valuable early on (within a year of the XEN 45 FDA clearance date) as surgeons adapt this new tech- nology and adopt it to their practice. Additionally, prospective studies further Glaucoma Dr. Radcliffe presented the best glaucoma papers at the "Best of ASCRS" session at the 2017 ASCRS•ASOA Symposium & Congress. Source: ASCRS Watch a video of Dr. Radcliffe's presentation on EWAR