24-Month Outcomes of Ahmed ClearPath® Glaucoma Drainage Device for Refractory Glaucoma

Abstract

Purpose To describe the safety and efficacy of the Ahmed ClearPath ® (ACP) 250 mm 2 glaucoma drainage device (GDD) in the treatment of refractory primary open-angle glaucoma (POAG). Patients and methods This was a retrospective, noncomparative, single-surgeon, interventional case series of adult patients with medically ± surgically refractory POAG undergoing ACP implantation. Intraocular pressure (IOP), the number of glaucoma medications, and complications were recorded over 24 months of follow-up. Primary outcomes included mean reductions in both IOP and medication use through 24 months, and secondary outcomes included the proportion of eyes achieving an IOP between 6 and 19 mmHg, IOP reduction by ≥20%, and reduction by ≥1 medication at last mean follow-up. Results Twelve eyes of 11 patients (mean age 71.3 ± 14.1 years) fit inclusion criteria and were enrolled. Most patients were Caucasian (n = 8), female (n = 10), and all had severe POAG (n = 11). The mean last follow-up was 18 months, at which time the mean (standard deviation) baseline IOP of 29.0 (7.6) mmHg was reduced to 12.2 (4.0) mmHg (58% reduction). 91.7% of eyes achieved an IOP between 6 and 19 mmHg, and 100% of eyes met an IOP reduction of ≥20%. Mean baseline number of glaucoma medications was 3.0 (0.9) and was reduced to 0.5 (0.7) at last mean follow-up (83.3% reduction), with 91.7% of eyes using ≥1 fewer medications. No long-term complications were observed, and short-term complications (mild hyphema, inflammation, and pain) were resolved by month 3. Conclusion To our knowledge, this is the second long-term study evaluating the efficacy of the Ahmed ClearPath drainage device in adult patients, and the first study with 24-months follow-up. The ACP device is safe and effective at reducing both IOP and medication burdens in patients with severe POAG. Additionally, minimal short-term complications were noted with no long-term adverse effects, increasing comfort for both the surgeon and the patient.

Bleb morphology of glaucoma drainage devices on magnetic resonance imaging

“…Most recorded complications appeared early in the post-operative period and were self-limited, with no serious, sight-threatening complication recorded (Table 2). These results are in line with previously published series, although direct comparison is limited by our smaller sample size and the wide range of success criteria across the literature (Budenz et al, 2015(Budenz et al, , 2016Christakis et al, 2016;Dorairaj et al, 2022;Grover et al, 2022;José et al, 2022;Tan et al, 2022;Tsai & Budenz, 2017;Vallabh et al, 2022).…”

“…Two glaucoma drainage devices have been extensively studied: the Ahmed Glaucoma Valve FP7 (AGV) and the Baerveldt Glaucoma Implant (BGI) (Barton et al, 2011;Budenz et al, 2015Budenz et al, , 2016Christakis et al, 2016;Tsai & Budenz, 2017). Recently, two GDDs have been introduced in clinical practice, the Paul Glaucoma Implant (PGI) and Ahmed ClearPath (ACP) with early positive results (Dorairaj et al, 2022;Grover et al, 2022;José et al, 2022;Koh et al, 2020;Tan et al, 2022;Vallabh et al, 2022).…”

Early Experience With Ahmed Clear Path Glaucoma Drainage Device in Childhood Glaucoma

“…In addition, because the suture fixation eyelets are positioned more anteriorly (Fig. 2), it was easier to place the scleral sutures while securing the ACP to the globe 7…”

New glaucoma drainage implants available to glaucoma surgeons

“…Dorairaj et al [9] reported long-term safety and efficacy outcomes (24 months; mean last follow up 18 months) of the 250 mm 2 Ahmed ClearPath GDD in a retrospective, single surgeon, noncomparative, interventional case series that included 12 eyes of 11 patients with medically and/or surgically refractory POAG. A 58% reduction in mean IOP from baseline (29 mmHg) to last follow up (12.2 mmHg) was observed.…”

“…Although the duration of 6 months of follow up in this study is short, the study characterized, for the first time, the safety and efficacy of the Ahmed ClearPath GDD, which were comparable to those of BGI as reported in landmark trials. Dorairaj et al [9] reported long-term safety and efficacy outcomes (24 months; mean last follow up 18 months) of the 250 mm 2 Ahmed ClearPath GDD in a retrospective, single surgeon, noncomparative, interventional case series that included 12 eyes of 11 patients with medically and/or surgically refractory POAG. A 58% reduction in mean IOP from baseline (29 mmHg) to last follow up (12.2 mmHg) was observed.…”