Corneal Endothelial Safety Profile Of Three Different Minimally Invasive Glaucoma Surgery Stents
Published 2023 - 41st Congress of the ESCRS
Reference: FP16.12 | Type: Free paper | DOI: 10.82333/nf2d-6387
Authors: Ticiana De Francesco* 1 , Iqbal Ahmed 2 , Arsham Sheybani 3 , Thomas W Samuelson 4
1John A. Moran Eye Center, ,University of utah,Salt lake city,United States;Ophthalmology,Clinica de Olhos De Francesco,Fortaleza,Brazil, 2John A. Moran Eye Center, ,University of Utah,Salt Lake City,United States;Ophthalmology,University of Toronto,Toronto,Canada, 3Department of Ophthalmology and Visual Sciences,Washington University in St. Louis School of Medicine,Washington,United States, 4Minnesota Eye Consultants,University of Minnesota,Minneapolis,United States
Purpose
To compare the effect of cataract surgery (CS) and iStent inject, Hydrus micro-stent, or CyPass micro-stent on corneal endothelial cell density (ECD) and endothelial cell loss (ECL) vs CS alone.
Setting
Comparative analysis of corneal endothelial data extracted from the publications of three randomized controlled multicenter pivotal trials and a pivotal trial extension study for three micro-invasive glaucoma surgery (MIGS) devices (iStent inject, Hydrus, CyPass).
Methods
Mean ECD and percent of eyes with clinically significant endothelial cell loss (ECL) >30% versus CS controls were extracted from pivotal trial publications and a pivotal trial extension study for these three micro-invasive glaucoma surgery (MIGS) devices. The same specular microscopy reading center (Cornea Image Analysis Reading Center, CIARC, University Hospitals Eye Institute, Cleveland, OH) was used for all three devices.
Results
Baseline mean ECD was similar in all groups. Mean 5-year change in ECD was -14.3% (iStent), -18.6% (Hydrus), and -20.4% (CyPass), vs. -14.8%, -12.7% and -10.1% in respective CS controls. At 5 years, the proportion of eyes with clinically significant ECL (>30%) was 9.4% (iStent), 20.8% (Hydrus), and 27.2% (CyPass), compared to 6.3%, 10.6%, and 10.0% in respective CS controls. Relative to control, this was 1.49X for iStent, 1.96X for Hydrus, and 2.72X for Cypass. This loss was primarily around the time of surgery for Hydrus, and it was progressive beyond 3 years for CyPass.
Conclusions
Amongst the 3 MIGS devices studied in pivotal trials, iStent inject demonstrated the most favorable endothelial safety profile with no statistical difference compared to cataract surgery alone at all time points up to 5 years postoperatively. Both CyPass and Hydrus showed significant differences in ECL and proportion >30% from baseline compared to cataract surgery alone. CyPass showed progressive ECL beyond 3 years implying a device-related mechanism of loss. Hydrus had initial ECL likely from intraoperative surgical trauma during implantation but showed an ECL rate comparable to the control cataract surgery group (aging loss) beyond 3 months implying device tolerability.