Table 1.
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.