Early postoperative safety and surgical outcomes after... : Journal of Cataract & Refractive Surgery (original) (raw)

Article

Early postoperative safety and surgical outcomes after implantation of a suprachoroidal micro-stent for the treatment of open-angle glaucoma concomitant with cataract surgery

Hoeh, Helmut MD, FEBO; Ahmed, Iqbal Ike K. MD; Grisanti, Swaantje MD; Grisanti, Salvatore MD; Grabner, Günther MD; Nguyen, Quang H. MD; Rau, Magda MD; Yoo, Sonia MD; Ianchulev, Tsontcho MD, MPH∗

From the Eye Hospital at the Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Teaching Hospital of the Ernst Moritz Arndt University Greifswald (Hoeh), Greifswald, and the Department of Ophthalmology (Swaantje Grisanti, Salvatore Grisanti), University of Lübeck, Lübeck, the Eye Clinic (Rau), Charm, Germany; the University of Toronto (Ahmed), Toronto, Ontario, Canada; University Eye Clinic Salzburg (Grabner), Salzburg, Austria; Scripps Clinic (Nguyen), La Jolla, University of California (Ianchulev), San Francisco, California, and Bascom Palmer Eye Institute (Yoo), Miami, Florida, USA

∗Corresponding author: Tsontcho Ianchulev, MD, MPH, University of California San Francisco, 127 Independence Drive, Menlo Park, California 94025, USA.

E-mail: [email protected]

Submitted June 8, 2012; revised October 6, 2012; accepted October 18, 2012.

Presented at the winter meeting of the Belgian Society of Cataract and Refractive Surgeons, Brussels, Belgium, April 2012.

Supported by Transcend Medical, Inc, Menlo Park, California, USA.

Gerard Smits, PhD, CSC Inc., provided statistical consultation. Carolyn A. Bates, PhD, Biomedical Strategic Communications, provided editorial support, including revising the manuscript based on author feedback and styling the manuscript for journal submission.

Abstract

Purpose

To evaluate the safety of a new suprachoroidal device, the Cypass micro-stent, for the surgical treatment of open-angle glaucoma (OAG) implanted in conjunction with cataract surgery.

Setting

Multicenter clinical study.

Design

Prospective interventional case series.

Methods

This is an interim report of an ongoing safety study. Patients with OAG glaucoma (Shaffer grade 3 and 4) who were also candidates for cataract surgery in the affected eye had standard phacoemulsification followed by micro-stent implantation in the supraciliary space. Included were patients with uncontrolled (≥21 mm Hg, Cohort 1) or controlled (<21 mm Hg, Cohort 2) medicated intraocular pressure (IOP) at baseline. Glaucoma medications were discontinued at surgery and resumed at the discretion of each investigator. Measures included adverse events/complications and postoperative changes in IOP or medication.

Results

The mean baseline medicated IOP was 21.1 mm Hg ± 5.91 (SD); the mean number of IOP-lowering medications was 2.1 ± 1.1 (N = 184). There were no major events such as retinal or choroidal detachment or endophthalmitis. The most common complications were transient early hypotony (13.8%) and transient IOP increase (10.5%). Uncontrolled patients (n = 57) had a 37% IOP reduction (P<.001), with more than a 50% reduction in glaucoma medications at 6 months (P<.001). Intraocular pressure–controlled patients (n = 41) had a 71.4% reduction in glaucoma medications (P<.001).

Conclusion

Initial clinical experience with the new micro-stent showed a low rate of surgical complications with concomitant decreases in IOP and/or glaucoma medications.

Financial Disclosure

Drs. Hoeh, Ahmed, Swaantje Grisanti, Salvatore Grisanti, Grabner, Nguyen, Rau, and Yoo are clinical investigators for Transcend Medical; Dr. Ahmed is a consultant to Transcend Medical; Dr. Ianchulev is an employee of Transcend Medical.