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Curr Opin OphthalmolMarch 202143 citations

Safety profile of minimally invasive glaucoma surgery.

Vinod Kateki, Gedde Steven J


AI Summary

This review found MIGS safety varies: trabecular-based devices have mostly mild, transient issues, while subconjunctival stents carry risks similar to traditional surgery, emphasizing the need for robust long-term safety data.

Abstract

Purpose of review: This article reviews the safety profile of trabecular meshwork/Schlemm's canal-based, subconjunctival, and suprachoroidal minimally invasive glaucoma surgery (MIGS).

Recent findings: Prospective randomized clinical trials and metaanalyses published during the 2019-2020 review period provided important data regarding the safety profile of trabecular meshwork/Schlemm's canal-based MIGS. Transient hyphema and intraocular pressure spikes are among the most common complications associated with this category of MIGS, but more serious adverse events such as cyclodialysis cleft formation may also occur. Trabecular bypass microstents and the intracanalicular scaffold are further subject to device-related complications, including malposition and obstruction. Recent case reports and retrospective case series have further characterized the safety profile of the subconjunctival gel stent, with adverse events ranging from self-limited hypotony to visually devastating endophthalmitis and suprachoroidal hemorrhage. Five-year results of the COMPASS XT study demonstrated significantly greater endothelial cell loss in patients randomized to receive CyPass Micro-Stent (Alcon Laboratories, Fort Worth, TX, USA) in combination with cataract surgery versus those who underwent cataract surgery alone, and ultimately led to a Food and Drug Administration Class I recall of the device.

Summary

Trabecular meshwork/Schlemm's canal-based procedures are generally among the safest MIGS, with mostly self-limited and nonvision-threatening complications. Subconjunctival gel stent insertion is associated with both bleb-related and stent-specific adverse events, which are similar to those observed with trabeculectomy and tube shunt surgery, respectively. Removal of the CyPass Micro-Stent from the market underscores the need for high-quality, long-term safety data regarding MIGS.


MeSH Terms

Glaucoma Drainage ImplantsGlaucoma, Open-AngleHumansIntraocular PressureMinimally Invasive Surgical ProceduresTonometry, OcularTrabecular MeshworkTrabeculectomy

Key Concepts6

Trabecular meshwork/Schlemm's canal-based minimally invasive glaucoma surgery (MIGS) are generally among the safest MIGS procedures, with mostly self-limited and nonvision-threatening complications.

TreatmentReviewn=Not specifiedCh45

Transient hyphema and intraocular pressure spikes are among the most common complications associated with trabecular meshwork/Schlemm's canal-based minimally invasive glaucoma surgery (MIGS), but more serious adverse events such as cyclodialysis cleft formation may also occur.

TreatmentReviewReview of prospective randomized clinical trials and metaanalysesn=Not specifiedCh45

Trabecular bypass microstents and intracanalicular scaffolds used in minimally invasive glaucoma surgery (MIGS) are subject to device-related complications, including malposition and obstruction.

TreatmentReviewn=Not specifiedCh45

Subconjunctival gel stent insertion is associated with both bleb-related and stent-specific adverse events, which are similar to those observed with trabeculectomy and tube shunt surgery, respectively.

TreatmentReviewReview of case reports and retrospective case seriesn=Not specifiedCh45

Adverse events associated with the subconjunctival gel stent range from self-limited hypotony to visually devastating endophthalmitis and suprachoroidal hemorrhage.

TreatmentReviewReview of case reports and retrospective case seriesn=Not specifiedCh45

Five-year results of the COMPASS XT study demonstrated significantly greater endothelial cell loss in patients randomized to receive CyPass Micro-Stent (Alcon Laboratories, Fort Worth, TX, USA) in combination with cataract surgery versus those who underwent cataract surgery alone, leading to a Food and Drug Administration Class I recall of the device.

TreatmentCohortProspective Cohort Studyn=Not specified (from COMPASS XT study)Ch45

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