Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Apr 1;50(4):369-377.
doi: 10.1097/j.jcrs.0000000000001365.

Corneal endothelial safety profile in minimally invasive glaucoma surgery

Iqbal Ike K Ahmed  1 , Arsham Sheybani, Ticiana De Francesco, Thomas W Samuelson
Affiliations
Randomized Controlled Trial

Corneal endothelial safety profile in minimally invasive glaucoma surgery

Iqbal Ike K Ahmed et al. J Cataract Refract Surg. .

Abstract

Purpose: To compare 5-year corneal endothelial safety of 3 minimally invasive glaucoma surgery (MIGS) devices (iStent inject , Hydrus Microstent, CyPass Micro-Stent).

Setting: U.S. multicenter trials.

Design: Post hoc 5-year analysis from prospective randomized single-masked pivotal trials.

Methods: Mild to moderate open-angle glaucoma subjects received a MIGS implant with phacoemulsification (implant + phaco) or phaco alone (control). In addition, 5-year end points comparing the implant and control groups included proportion of eyes with significant endothelial cell loss (ECL) (>30% or ≥30% vs baseline) and 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, diff: 3.2%, 95% CI, -5.0% to 11.3%, P = .77). Hydrus (20.8% vs 10.6%, diff: 10.2%, 95% CI, 3.2% to 17.2%, P = .01) and CyPass (27.2% vs 10.0%, diff: 17.2%, 95% CI, 5.6% to 28.7%, P = .02) had more eyes with ECL vs controls (iStent inject 1.49X, Hydrus 1.96X, CyPass 2.72X vs controls). Mean ECD over 60 months for iStent inject was indistinguishable vs control, whereas greater ECL was observed primarily 3 months postoperative (Hydrus) or accelerated after 2 years (CyPass). No iStent inject or Hydrus subjects developed persistent corneal edema, whereas 7 CyPass-implanted eyes developed ECL-related complications.

Conclusions: Through 5 years postoperative, there were no differences in proportion of eyes with significant ECL or mean ECD between the iStent inject and control groups. There was greater 5-year ECL and lower ECD in the Hydrus and CyPass groups vs controls. The Hydrus ECL rate mirrored control after 3 months; the CyPass ECL rate accelerated vs control.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Corneal endothelial cell data in 3 prospective randomized microinvasive glaucoma surgery stent trials. The number of patients is indicative of the patients with ECD data collected, which may differ from the number of patients in Table 1. ECD = endothelial cell density; Phaco = phacoemulsification
Figure 2.
Figure 2.
Proportion (%) of eyes with >30% (iStent inject, CyPass) or ≥30% (Hydrus) ECL. A: iStent inject. B: Hydrus Microstent. C: CyPass Micro-Stent. The Hydrus publications reported ECL ≥30%, while the iStent inject and CyPass publications reported ECL >30%. For consistency across devices, an additional analysis of the iStent inject data was completed to determine the rates of both ≥30% ECL and >30% ECL. The outcomes for both cutoffs were identical (presented in Table 2). *Denotes statistically significant difference between treatment and control groups. ECL = endothelial cell loss; Phaco = phacoemulsification
Figure 3.
Figure 3.
Mean ECD (cells/mm2). A: iStent inject. B: Hydrus Microstent. C: CyPass Micro-Stent. *Denotes statistically significant difference between treatment and control groups. ECD = endothelial cell density; Phaco = phacoemulsification
See this image and copyright information in PMC

References

    1. GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health 2021;9:e144–e160 - PMC - PubMed
    1. Vinod K, Gedde SJ. Safety profile of minimally invasive glaucoma surgery. Curr Opin Ophthalmol 2021;32:160–168 - PubMed
    1. Minckler DS, Francis BA, Hodapp EA, Jampel HD, Lin SC, Samples JR, Smith SD, Singh K. Aqueous shunts in glaucoma: a report by the American Academy of Ophthalmology. Ophthalmology 2008;115:1089–1098 - PubMed
    1. Chaurasia S, Vanathi M. Specular microscopy in clinical practice. Indian J Ophthalmol 2021;69:517–524 - PMC - PubMed
    1. Lass JH, Benetz BA, He J, Hamilton C, Von Tress M, Dickerson J, Lane S. Corneal endothelial cell loss and morphometric changes 5 years after phacoemulsification with or without CyPass micro-stent. Am J Ophthalmol 2019;208:211–218 - PubMed

Publication types