Long-Term Endothelial Safety Profile With iStent Inject in Patients With Open-Angle Glaucoma.
Ahmed Iqbal Ike K, Sheybani Arsham, De Francesco Ticiana, Lass Jonathan H, Benetz Beth Ann, Samuelson Thomas W, Usner Dale, Katz L Jay
AI Summary
This 5-year study found iStent inject with phacoemulsification for glaucoma had no device-related complications or worse endothelial cell loss than phacoemulsification alone, demonstrating long-term corneal safety.
Abstract
Purpose
To report 5-year postoperative safety data of iStent inject, including overall stability, endothelial cell density (ECD), and endothelial cell loss (ECL) in patients with mild-to-moderate primary open-angle glaucoma (POAG).
Design
5-year follow-up safety study of the prospective, randomized, single-masked, concurrently controlled, multicenter iStent inject pivotal trial.
Methods
In this 5-year follow-up safety study of the 2-year iStent inject pivotal randomized controlled trial, patients receiving iStent inject placement and phacoemulsification or phacoemulsification alone were studied for the incidence of clinically relevant complications associated with iStent inject placement and stability. Corneal endothelial endpoints were mean change in ECD from screening and proportion of patients with >30% ECL from screening, from analysis of central specular endothelial images by a central image analysis reading center at several time points through 60 months postoperatively.
Results
Of the 505 original randomized patients, 227 elected to participate (iStent inject and phacoemulsification group, n = 178; phacoemulsification-alone control group, n = 49). No specific device-related adverse events or complications were reported through month 60. No significant differences were observed in mean ECD, mean percentage change in ECD, or proportion of eyes with >30% ECL between the iStent inject and control groups at any time point; mean percentage decrease in ECD at 60 months was 14.3% ± 13.4% in the iStent inject group and 14.8% ± 10.3% in the control group (P = .8112). The annualized rate of ECD change from 3 to 60 months was neither clinically nor statistically significant between groups.
Conclusions
Implantation of iStent inject during phacoemulsification in patients with mild-to-moderate POAG did not produce any device-related complications or ECD safety concerns compared to phacoemulsification alone through 60 months.
MeSH Terms
Shields Classification
Key Concepts4
Implantation of iStent inject during phacoemulsification in patients with mild-to-moderate primary open-angle glaucoma (POAG) did not produce any device-related complications or endothelial cell density (ECD) safety concerns compared to phacoemulsification alone through 60 months.
No significant differences were observed in mean endothelial cell density (ECD), mean percentage change in ECD, or proportion of eyes with >30% endothelial cell loss (ECL) between the iStent inject and phacoemulsification-alone control groups at any time point through 60 months in patients with mild-to-moderate primary open-angle glaucoma (POAG).
The mean percentage decrease in endothelial cell density (ECD) at 60 months was 14.3% ± 13.4% in the iStent inject group and 14.8% ± 10.3% in the phacoemulsification-alone control group (P = .8112) in patients with mild-to-moderate primary open-angle glaucoma (POAG).
The 5-year follow-up safety study of the iStent inject pivotal trial included 227 patients (iStent inject and phacoemulsification group, n = 178; phacoemulsification-alone control group, n = 49) who elected to participate from the original 505 randomized patients with mild-to-moderate primary open-angle glaucoma (POAG).
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