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Related Experiment Videos

Dominic Moogon Choo1, Tyler Avery Durham1, Hongyi Zhang1

  • 1Department of Ophthalmology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390, USA.

Graefe'S Archive for Clinical and Experimental Ophthalmology = Albrecht Von Graefes Archiv Fur Klinische Und Experimentelle Ophthalmologie
|November 12, 2025
PubMed
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Real-world iStent surgery shows malposition and elevated intraocular pressure (IOP) as common complications. Specific device generations have unique risks like trocar damage, requiring tailored surgical care.

Area of Science:

  • Ophthalmology
  • Medical Device Safety
  • Glaucoma Surgery

Background:

  • Minimally invasive glaucoma surgery (MIGS) using iStent devices aims to reduce intraocular pressure (IOP).
  • Understanding real-world complications is crucial for patient safety and device improvement.

Purpose of the Study:

  • To analyze intraoperative and early postoperative complications associated with iStent surgery.
  • To identify and examine specific adverse events across different iStent generations.

Main Methods:

  • Querying the Manufacturer and User Facility Device Experience database for iStent reports (January 2014-March 2024).
  • Excluding late postoperative events, inadequate reports, and indirect sources.
  • Analyzing adverse events categorized by iStent device generation.
Keywords:
Device malfunctionMicro-Invasive glaucoma surgery (MIGS)Post-market surveillanceSurgical techniqueTrocar damage

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Main Results:

  • 808 reports analyzed, with varying adverse events per generation.
  • Common intraoperative issues: malposition (iStent Trabecular Micro-Bypass, Inject, Infinite) and trocar damage (Inject W).
  • Elevated IOP was the most frequent early postoperative event across all generations; hyphema noted for Infinite.

Conclusions:

  • Post-market data reveal distinct complication profiles for iStent generations.
  • Malposition and elevated IOP are leading complications.
  • Generation-specific trends, like Inject W trocar damage, necessitate focused surgical vigilance.