Long-Term Endothelial Safety Profile With iStent Inject in Patients With Open-Angle Glaucoma

Area of Science:

• Ophthalmology
• Glaucoma Research
• Medical Device Safety

Background:

• Primary open-angle glaucoma (POAG) is a leading cause of irreversible blindness.
• The iStent inject is a micro-invasive glaucoma surgical device designed to reduce intraocular pressure.
• Long-term safety data is crucial for evaluating the clinical utility of new glaucoma treatments.

Purpose of the Study:

• To assess the 5-year postoperative safety of the iStent inject in patients with mild-to-moderate POAG.
• To evaluate overall device stability, endothelial cell density (ECD), and endothelial cell loss (ECL) post-implantation.
• To compare safety outcomes between iStent inject implantation combined with phacoemulsification versus phacoemulsification alone.

Main Methods:

• A 5-year follow-up safety analysis of a prospective, randomized, single-masked, multicenter trial.
• Patients with mild-to-moderate POAG received either iStent inject plus phacoemulsification or phacoemulsification alone.
• Corneal endothelial cell density (ECD) and endothelial cell loss (ECL) were assessed via specular microscopy at multiple time points up to 60 months.

Main Results:

• No specific device-related adverse events or complications were reported through 60 months.
• No significant differences in mean ECD, mean percentage change in ECD, or proportion of eyes with >30% ECL were observed between the iStent inject and control groups.
• The mean percentage decrease in ECD at 60 months was comparable between groups (14.3% ± 13.4% vs. 14.8% ± 10.3%), with no statistically significant difference.

Conclusions:

• iStent inject implantation during phacoemulsification is safe for patients with mild-to-moderate POAG.
• The procedure did not result in device-related complications or endothelial cell safety concerns up to 5 years postoperatively.
• Safety outcomes were comparable to phacoemulsification alone, supporting its use in this patient population.