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Daniel Skipper OMSIII, Lincoln Memorial University-Debusk College of Osteopathic Medicine, Harrogate, TN Kenneth W. Olander MD PhD, University Eye Surgeons, Maryville, TN
Bart Beasley, Senior Director of Marketing, Transcend Medical, Inc.
Purpose: To evaluate the intraoperative and post-operative safety of a new suprachoroidal device for the surgical treatment of glaucoma. We report the safety data from the pilot clinical experience of 27 consecutive patients who underwent combined phaco surgery and Cypass implantation. Setting/Venue: Multicenter, prospective, interventional case series from Canada, Manila and Malaysia. Methods: 27 subjects (56% male) with an average age of 70 and history of POAG were enrolled and underwent clear-corneal surgical implantation of a CyPass suprachoroidal device in each study eye. The implant was introduced ab-interno across the anterior chamber using a delivery system. All patients underwent implantation in combination with phaco surgery. Intraoperative and post-operative adverse events were collected as part of the study monitoring. Postoperative followup visits took place on 1 and 7 days and 1, 3 and 6 months. Results: All 27 cases were successfully implanted and device proper insertion was conﬁrmed by gonioscopy. There were no device malpositions. Two cases had intraoperative hyphema, which was minimal and completely resolved by week 1. There were no device-related intraoperative complications. Posterior capsule tear resulting from the phaco procedure was not device-related. There were no retinal, choroidal or corneal adverse events. Post- operatively there were no cases of hypotony or device migration. In the immediate post- operative follow-up one anteriorized device was repositioned by tapping. Mean reduction from medicated baseline IOP to 6 months was 10 mmHg (40%) with a concomitant reduction of medications. Conclusion: Ab-interno suprachoroidal surgery and CyPass implantation can be successfully achieved without complications in the setting of phaco surgery. This minimally invasive approach to enhance uveoscleral outﬂow can lead to sustained IOP lowering.
The CyPass implant within the anterior chamber. The CyPass implant is a tube with a through-lumen. The length of the device is 6.35mm. It has a 0.30mm inner diameter and 0.51mm total outer diameter. The implant is made of polyimide, a material used in various ophthalmic medical device implants. The purpose of the CyPass implant is to capture aqueous ﬂuid in the proximal end from the anterior chamber of the eye and transport the ﬂuid to the distal end of the tube into the suprachoroidal space. Pilot study of CyPass in combination with phaco (N = 27) 6 month follow-up after cataract surgery/CyPass implantation Mean medication was reduced by >60%
• Multicenter, prospective, interventional case series from Canada, Manila, and Malaysia. All 27 cases were successfully implanted and the proper insertion of the device was conﬁrmed by gonioscopy.
• Surgical therapies for glaucoma are targeted at increasing aqueous outﬂow. Aqueous outﬂow is increased by creating alternate or improved pathways to Schlemn’s canal or directing the ﬂow of aqueous to an alternative drainage site outside the interior of the eye. • Filtering surgeries, like trabeculectomy or implantation of an aqueous shunt to an external reservoir, are associated with complications including hypotony, infection, bleb ﬁbrosis and erosion1. Estimates of failure rates of ﬁltering surgery alone or in combination with medical therapy in a previously unoperated eye come from the Advanced Glaucoma Intervention Study2. The ten-year results say there is a 30% failure rate in African Americans and a 20% failure rate in Caucasian Americans. Long-term control is often achieved with these methods, but many patients require continued therapy or re-operation, which carries a higher failure rate3. • These limitations in ﬁltering surgery have sparked an interest in minimally invasive glaucoma surgery (MIGS) and devices that employ a different mechanism of increasing aqueous outﬂow, like the CyPass implant (Transcend Medical, Menlo Park, California). • The CyPass implant is a surgically implantable microstent composed of polyimide, a material used in the production of lens haptics. The CyPass implant allows decreased resistance to aqueous ﬂow from the anterior chamber of the eye to the suprachoroidal space. This space has negative pressure, a result of high oncotic absorptive pressure of uveal vessels. The ab-interno surgical approach allows for conjunctival sparing, no scleral penetration, and allows the trabecular meshwork to remain intact. • CyPass implantation can take place as a stand-alone procedure or in conjuction with phacoemulsiﬁcation. • The purpose of this pilot study was to evaluate the intraoperative and postoperative safety of the CyPass implant, an ab-interno suprachoroidal device, in combination with phacoemulsiﬁcation.
• 27 subjects (56% male) with an average age of 70 and a history of POAG were enrolled and underwent clear-corneal surgical implantation of a CyPass suprachoroidal device. • All patients underwent ab-interno implantation in combination with phacoemulsiﬁcation. • Intraoperative and post-operative adverse events were collected as part of the study. Post-operative follow-up visits took place on day 1 and 7, as well as months 1,3, and 6.
• There were no permanent device malpositions, but one anteriorized device was repositioned by tapping. • Two cases had intraoperative hyphema, which was minimal and completely resolved by week 1. • There were no device-related intraoperative complications. • Posterior capsule tear resulting from the phaco procedure was not device-related. • There were no retinal, choroidal or corneal adverse events. • Post-operatively there were no cases of hypotony or device migration.
IOP EFFECT DISCUSSION
• The CyPass was safely implanted in patients undergoing cataract surgery. There was a low rate of intraoperative and immediate post events, and no serious device-related adverse events.
• The Cypass signiﬁcantly lowered IOP form a medicated baseline. This difference was greater than previously published rates of IOP lowering seen with cataract surgery alone. • The CyPass also allowed a reduction in the number of ocular hypotensive agents required to control IOP.
• Ab-interno suprachoroidal surgery and CyPass implantation can be successfully achieved without complications in the setting of phaco surgery. This minimally invasive approach to enhance uveoscleral outﬂow can lead to sustained IOP lowering. • Larger patient studies and longer follow up will be necessary to market the device.
Pilot study of CyPass in combination with phaco (N = 27) 6 month follow-up after cataract surgery/CyPass implantation Mean reduction from medicated baseline IOP to 6 months as 10 mmHg (40%)
Study funded by Transcend Medical, Inc.
1. Minckler DS, Francis BA, Hodapp EA, et al. Aqueous shunts in glaucoma: a report by the American Academy of Ophthalmology. Ophthalmology. 2008 Jun; 115(6): 1089-98. 2. The advanced glaucoma intervention study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results. Ophthalmology 2004; 111: 651-64. 3. Lichter PR, Musch DC. Gillespie BW, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001; 108: 1943-53.
Study conducted by: Helmut Hoeh MD PhD; Magda Rau MD; Tsontcho Ianchulev MD PhD This poster was presented at the Annual Meeting of the American Osteopathic Colleges of Ophthalmologists and Otolaryngologists May 9-13, 2012, in Palm Springs, CA.