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: 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
Patients 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 or equal to 30% compared with baseline, and mean endothelial cell density (ECD).
Results
Comparable proportions of eyes in the iStent inject + phaco and control groups experienced 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 CyPass, 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 respective 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 iStent inject was indistinguishable from that of the control group. In contrast, greater endothelial cell loss was observed primarily during the first 3 postoperative months with Hydrus, whereas ECL accelerated after 2 years with CyPass.
No subjects treated with iStent inject or Hydrus developed persistent corneal edema. In contrast, seven eyes implanted with CyPass developed complications related to endothelial cell loss.
Conclusão
The 5-year results demonstrate that there was no significant difference in corneal endothelial safety between iStent inject and phacoemulsification alone.
In contrast, the Hydrus and CyPass groups demonstrated greater endothelial cell loss and lower endothelial cell density compared with their respective control groups. The endothelial cell loss associated with Hydrus was primarily observed during the early postoperative period and subsequently mirrored the control group after approximately 3 months.
For CyPass, endothelial cell loss accelerated after 2 years, resulting in a greater long-term decline in endothelial cell density and an increased incidence of ECL-related complications.
These findings highlight differences in the long-term corneal endothelial safety profiles among commonly used MIGS devices and emphasize the importance of monitoring endothelial health during extended follow-up.
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.