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. 2021 Jun 14;35(12):3202–3221. doi: 10.1038/s41433-021-01595-x

Table 1.

Conventional glaucoma drainage devices, the trabeculectomy-modifying EX-PRESS® device, and the new MIGS devices—summary of the current regulatory status, advantages, and disadvantages of each group of devices (aqueous shunts—valved and non-valved; MIGS devices—Schlemm’s canal, suprachoroidal, and subconjunctival devices), and effectiveness of each device in reducing IOP, as reported in selected studies.

Type of device Site of anatomical intervention Device (Manufacturer) Regulatory status Advantages Disadvantages % IOP reduction at follow-up (Study type)
Conventional glaucoma drainage devices Subconjunctival space Molteno® Glaucoma Drainage Device (Molteno Ophthalmic Limited) CE mark, FDA approval Larger surface area of end plate provides greater long-term IOP reduction Delayed functioning until encapsulation of plate occurs (high IOP in the postoperative period); Greater risk of postoperative hypotony and hypotony-related complications 53.4% at 2 years (Prospective, randomised clinical trial) [26]
Baerveldt® Glaucoma Implant (Johnson & Johnson Vision) CE mark, FDA approval 57.4% at 5 years (Prospective, randomised clinical trial) [27]
PAUL® Glaucoma Implant (Advanced Ophthalmic Innovations) CE mark granted in 2017 Smaller tube diameter occupies less space in the anterior chamber angle Complications reported so far: shallow anterior chamber, tube occlusion and exposure, hypotony requiring intervention and endophthalmitis 42.9% at 1 year (Prospective, single-arm clinical trial) [38]
Ahmed® Glaucoma Valve (New World Medical, Inc.) CE mark, FDA approval Valve minimises risk of postoperative hypotony and hypotony-related complications; Allows immediate IOP reduction Higher rate of bleb encapsulation and smaller surface area of end plate may decrease IOP-reducing efficacy; Valve malfunction can result in hypotony and hypotony-related complications 46.6% at 5 years (Prospective, randomised clinical trial) [27]
Ahmed® ClearPath Glaucoma Drainage Device (New World Medical, Inc.) CE mark, FDA approved since 2019 Equivalent to Baerveldt implant Equivalent to Baerveldt implant Equivalent to Baerveldt implant
Trabeculectomy- modifying device Subconjunctival space EX-PRESS® Glaucoma Filtration Device (Alcon Laboratories, Inc.) CE mark, FDA approved since 2002 High efficacy in reducing IOP; More predictable than trabeculectomy, with less IOP fluctuations during the early postoperative period; Complications are less frequent when compared to trabeculectomy Risk of failure as a consequence of subconjunctival fibrosis and bleb-related complications; hypotony is commonly reported, as well as erosion, displacement, and blockage of the implant 41.4% at 2 years (Prospective, randomised clinical trial) [29]
Minimally invasive glaucoma surgery (MIGS) devices Schlemm’s canal iStent® (Glaukos Corporation) CE mark granted in 2004, FDA approved since 2012 Lower risk of hypotony and hypotony-related complications; Favourable safety profile High risk of fibrosis that may lead to device obstruction; Modest IOP reduction, which makes these devices only suitable for patients with mild-to-moderate glaucoma; Not suitable for patients with high episcleral venous pressure 33.7% at 1 year (Prospective, randomised clinical trial) [30]
iStent inject® (Glaukos Corporation) CE mark granted in 2010 31.0% at 2 yearsa (Prospective, randomised clinical trial) [31]
iStent inject® W (Glaukos Corporation) FDA approval since 2020 No published studies
Hydrus® Microstent (Ivantis, Inc.) CE mark granted in 2011, FDA approved since 2018 37.1% at 1 year (Prospective, randomised clinical trial) [30]
Suprachoroidal space CyPass® Micro-Stent (Alcon Laboratories, Inc.) Withdrawn from the global market in 2018 More effective at reducing IOP as compared with Schlemm’s canal MIGS devices High risk of fibrosis that may lead to device obstruction; Unpredictable IOP spikes; Higher risk for (transient) hypotony 34.3% at 5 yearsa (Prospective, randomised clinical trial) [32]
iStent SUPRA® (Glaukos Corporation) CE mark granted in 2010, under FDA review No published studies
SOLX® gold shunt (SOLX, Inc.) CE mark granted, approved in Canada 35.8 % at 5 years (Prospective, randomised clinical trial) [33]
STARflo™ Glaucoma Implant (iSTAR Medical) CE mark granted in 2012 38.5% at 2 years (Prospective study) [34]
MINIject™ (iSTAR Medical) Application for CE marking expected in 2020 39.1% at 6 months (Prospective, single-arm clinical trial) [35]
Subconjunctival space XEN® Gel Stent (Allergan, Inc.) CE mark granted in 2013, FDA approval since 2016 High efficacy in reducing IOP, making these devices suitable for patients with more severe glaucoma; Possibility of applying antifibrotic agents in the subconjunctival space optimises the fibrotic response; Modulating bleb encapsulation is possible with techniques such as bleb massage or bleb needling Risk of failure as a consequence of subconjunctival fibrosis and bleb-related complications 36.3% at 1 year (Prospective, single-arm clinical trial) [36]
PRESERFLO™ MicroShunt (Santen) CE mark granted in 2012, under FDA review 46.7% at 5 years (Prospective, nonrandomized, single-arm clinical trial) [101]

aIn combination with cataract surgery.