Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery

Kim, Julie H.; Friedman, David S.; Kiang, Tina; Moster, Marlene R.; Parrish, Richard K.; Rorer, Eva; Samuelson, Thomas W.; Tarver, Michelle E.; Singh, Kuldev; Eydelman, Malvina B.

doi:10.1016/j.ophtha.2015.02.029

Cited by 71 publications

(52 citation statements)

References 21 publications

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“…MIGS devices that can be implanted in conjunction with cataract surgery to facilitate aqueous drainage into Schlemm's canal [9] or the supraciliary space [10] offer modest IOP lowering. An ab interno gelatin stent (XEN®45, Allergan plc, Dublin, Ireland) that also meets the criteria for MIGS [11] bypasses conventional outflow pathways that are known to be obstructed in primary open-angle glaucoma (POAG) by creating a connection between the anterior chamber and subconjunctival space [8], in a manner similar to the gold standard trabeculectomy. The device is implanted ab interno, either as a stand-alone procedure or in combination with cataract surgery, without conjunctival dissection.…”

Section: Introductionmentioning

confidence: 99%

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Reitsamer

Sng

Vera³

et al. 2019

Graefes Arch Clin Exp Ophthalmol

172

173

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Purpose To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary openangle glaucoma (POAG). Methods In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. Results The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were − 6.5 (5.3) mmHg and − 1.7 (1.3) at month 12 and − 6.2 (4.9) mmHg and − 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. Conclusions The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).

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Section: Introductionmentioning

confidence: 99%

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Reitsamer

Sng

Vera³

et al. 2019

Graefes Arch Clin Exp Ophthalmol

172

173

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“…For instance, a new group of procedures is pursuing a less invasive approach, aiming to reduce possible complications. Minimal Invasive Glaucoma Surgery (MIGS) includes a variety of interventions, extending from miniaturized versions of trabeculectomy to minimally invasive shunt or bypass operations, differing from traditional tube shunt procedures through limited surgical manipulation of the sclera and the conjunctiva [5].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of XEN®—Implantation vs. trabeculectomy: Data of a “real-world” setting

et al. 2020

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ObjectiveTo compare surgical success, postoperative intraocular pressure and complication rates between trabeculectomy and XEN gelstent surgery in a cohort of glaucoma patients in a typical clinical setting. MethodsA retrospective cohort study of consecutive patients with refractory open-angle glaucoma including patients who underwent either stand-alone XEN gelstent insertion with Mitomycin C or trabeculectomy with Mitomycin C between 2016 and 2018 at the University Eye Hospital Mainz, Germany. Primary outcome measure was the proportion of surgical success 1 year after surgery. Patients with an IOP �18mmHg, an intraocular pressure reduction of >20% and in no need of revision surgery or topical medication were considered a complete surgical success. If topical therapy was necessary, they were considered a qualified success. Multivariable logistic regression analysis was carried out for the primary outcome including gender, age, preoperative intraocular pressure and number of medication classes used preoperatively as adjustment variables. Results171 eyes of 144 patients were included, including 82 eyes of 58 patients in the XEN group and 89 eyes of 86 patients in the trabeculectomy group. The primary outcome defined as the proportion of surgical success after 1 year (mean 11.1 months ± 2.2) was similar for both groups. The complete success proportion was 65.5% (95%-CI: 55.6-75.9%) in the trabeculectomy group, and 58.5% (95%-CI: 47.6-69.4%) in the XEN group and not statistically different in our analysis model (crude OR = 0.61; 95%-CI: 0.31-1.22; adjusted OR = 0.66; 95%-CI: 0.32-1.37). The intraocular pressure reduction, as secondary outcome measure, was higher in the trabeculectomy group (10.5 mmHg) compared to the XEN group (7.2 mmHg; p = 0.003) at the 12-month follow-up.Citation: Wagner FM, Schuster AK-G, Emmerich J, Chronopoulos P, Hoffmann EM (2020) Efficacy and safety of XEN®-Implantation vs. trabeculectomy: Data of a "real-world" setting. PLoS ONE 15(4): e0231614. https://doi.org/10.

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“…MIGS are ab interno procedures requiring minimal to no conjunctival manipulation or scleral dissection, which can be safely performed at the time of another intraocular procedure, specifically cataract extraction by phacoemulsification. They improve aqueous outflow, as traditional filtering surgeries do, but typically to a more modest degree than trabeculectomy or tube shunt implantation and with fewer risks than those more invasive surgeries (Caprioli 2015; Francis 2011; Spaeth 2015). While MIGS interventions are not generally used as first-line therapy at this time, they may reduce the need for medication.…”

Section: Introductionmentioning

confidence: 99%

Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma

Gazzard

Bunce

et al. 2016

Cochrane Database of Systematic Reviews

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This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary objective is to assess the comparative effectiveness and safety of ab interno trabecular bypass surgery with iStent or iStent inject for OAG in comparison to conventional medical, laser, or surgical treatment. A secondary objective is to examine the effectiveness and safety of iStent or iStent Inject surgery in people who have concomitant phacoemulsification.

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Special Commentary: Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery

Cited by 71 publications

References 21 publications

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Efficacy and safety of XEN®—Implantation vs. trabeculectomy: Data of a “real-world” setting

Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma

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