Surgical Summit Online Final Program 2018

Issue link:

Contents of this Issue


Page 1 of 14

2 ONE CYPASS ® MICROSTENT IS ALL IT TAKES TO CONNECT TO SAFE, CONSISTENT, LONGTERM IOP CONTROL and done © 2017 Novartis 09/17 US-CYP-17-E-2272 FOR AN EXPERIENCE LIKE NO OTHER, CONNECT WITH AN ALCON REPRESENTATIVE TODAY. IN THE COMPASS STUDY AT TWO YEARS 1,2 : • 72.5% of patients achieved a ≥20% reduction in IOP (n=374) • 93% of patients were medication free* • Safety profi le similar to cataract surgery alone References: 1. CyPass ® Micro-Stent Instructions for Use. 2. Vold S, Ahmed IIK, Craven ER, et al. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsifi cation in patients with open-angle glaucoma and cataracts. Ophthalmology. 2016;123(10):2103-2112. FOR THE REDUCTION OF IOP IN MILD TO MODERATE PRIMARY OPENANGLE GLAUCOMA AT THE TIME OF CATARACT SURGERY *Those patients who attained an unmedicated mean diurnal IOP reduction of 20% or more as compared to baseline in the absence of IOP-a™ ecting surgery during the study. and done IMPORTANT PRODUCT INFORMATION CAUTION: FEDERAL €USA‚ LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. INDICATION: The Micro-Stent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG). CONTRAINDICATIONS: Use of the CyPass Micro-Stent is contraindicated in the following circumstances or conditions: (1) in eyes with angle-closure glaucoma; and (2) in eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle. MRI INFORMATION: The CyPass Micro-Stent is magnetic resonance (MR) Safe: the implant is constructed of polyimide material, a non-conducting, non-metallic, non-magnetic polymer that poses no known hazards in all magnetic resonance imaging environments. WARNINGS: Gonioscopy should be performed prior to surgery to exclude peripheral anterior synechiae (PAS), rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. PRECAUTIONS: The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the CyPass Micro-Stent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, in eyes with signi cant prior trauma, chronic in ammation, eyes with an abnormal anterior segment, eyes with chronic in ammation, eyes with glaucoma associated with vascular disorders, pseudophakic eyes with glaucoma, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open-angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes with laser trabeculoplasty performed ≤ 3 months prior to the surgical screening visit, eyes with unmedicated IOP less than 21 mmHg or greater than 33 mmHg, eyes with medicated IOP greater than 25 mmHg, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment, and when implantation is without concomitant cataract surgery with IOL implantation for visually signi cant cataract. The safety and effectiveness of use of more than a single CyPass Micro-Stent has not been established. ADVERSE EVENTS: In a randomized, multicenter clinical trial comparing cataract surgery with the CyPass Micro-Stent to cataract surgery alone, the most common postoperative adverse events included: BCVA loss of 10 or more letters at 3 months after surgery (8.8% for the CyPass Micro-Stent vs. 15.3% for cataract surgery only); anterior chamber cell and are requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual eld mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). AT TENTION: PLEASE REFER TO THE INSTRUCTIONS FOR A COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS.

Articles in this issue

Archives of this issue

view archives of digital.SurgicalSummit.EyeWorld - Surgical Summit Online Final Program 2018