Iqbal Ike K. Ahmed, MD, Arsham Sheybani, MD, Ticiana De Francesco, MD, Thomas W. Samuelson, MD.
Purpose
To compare the 5-year corneal endothelial safety of three minimally invasive glaucoma surgery (MIGS) devices: the iStent inject, Hydrus Microstent, and CyPass Micro-Stent.
Setting
U.S. multicenter trials.
Design
Post hoc 5-year analysis of prospective, randomized, single-masked pivotal trials.
Methods
Subjects with mild to moderate open-angle glaucoma received a MIGS implant combined with phacoemulsification (implant + phaco) or underwent phacoemulsification alone (control).
The 5-year endpoints comparing the implant and control groups included the proportion of eyes with significant endothelial cell loss (ECL), defined as greater than 30% or at least 30% compared with baseline, as well as mean endothelial cell density (ECD).
Results
Comparable proportions of eyes in the iStent inject + phaco and control groups had significant 60-month ECL (9.4% vs. 6.3%, respectively; difference: 3.2%; 95% CI, −5.0% to 11.3%; P = .77).
In the Hydrus group, 20.8% of eyes experienced significant ECL compared with 10.6% in the control group (difference: 10.2%; 95% CI, 3.2% to 17.2%; P = .01).
For the CyPass group, significant ECL occurred in 27.2% of eyes compared with 10.0% of controls (difference: 17.2%; 95% CI, 5.6% to 28.7%; P = .02).
Compared with the control groups, the proportion of eyes with significant ECL was approximately 1.49 times higher with iStent inject, 1.96 times higher with Hydrus, and 2.72 times higher with CyPass.
Mean ECD over 60 months for the iStent inject group was indistinguishable from that of the control group. In contrast, greater endothelial cell loss was observed primarily during the first 3 postoperative months with the Hydrus device, whereas ECL accelerated after 2 years in eyes implanted with CyPass.
No subjects receiving iStent inject or Hydrus developed persistent corneal edema. In contrast, seven eyes implanted with CyPass developed complications related to endothelial cell loss.
Conclusions
Through 5 years postoperatively, there were no significant differences in the proportion of eyes with significant endothelial cell loss or in mean endothelial cell density between the iStent inject and control groups.
In contrast, the Hydrus and CyPass groups demonstrated greater 5-year endothelial cell loss and lower endothelial cell density compared with their respective control groups.
The rate of endothelial cell loss associated with Hydrus was similar to that of the control group after the first 3 postoperative months. In contrast, the rate of endothelial cell loss associated with CyPass accelerated over time compared with the control group.
Referência
Journal of Cataract & Refractive Surgery. 2024;50:369–377. Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.