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Glaucoma Surgery & The EX-PRESS® Device

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Presentation on theme: "Glaucoma Surgery & The EX-PRESS® Device"— Presentation transcript:

1 Glaucoma Surgery & The EX-PRESS® Device
Ike K. Ahmed, MD EXP11732SK

2 EX-PRESS® Device Brief Statement
CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed. GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device. The selection of the appropriate version is according to the doctor's discretion. CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist: · Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis. · Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device. · Patients diagnosed with angle closure glaucoma. WARNINGS/PRECAUTIONS: · The surgeon should be familiar with the instructions for use. · The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised. · This device is for single use only. · MRI of the head is permitted, however not recommended, in the first two weeks post implantation. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events. EXP11706SK EXP11732SK

3 Disclosures Consultant (+S) Research Grants Speaker Honoraria (S)
Alcon Allergan Aquesys AMO Carl Zeiss Clarity Endooptiks Eyelight Glaukos iScience Ivantis Pfizer Transcend Research Grants Alcon® Allergan Aquesys Carl Zeiss iScience Merck Pfizer SOLX Visiogen Speaker Honoraria (S) New World Medical Ike K. Ahmed EXP11732SK Ike K. Ahmed, MD

4 Glaucoma Surgical Options

5 Glaucoma Surgery Trends
Evolutionary improvements in trabeculectomy-like procedures Canaloplasty EX-PRESS® glaucoma filtration device Increased use of long-tube shunts Ahmed, Baerveldt glaucoma drainage devices New field “Minimally Invasive Glaucoma Surgery (MIGS)” Safe, quick procedures with modest IOP-lowering Use at time of cataract surgery Question 1 Ike K. Ahmed, MD EXP11732SK

6 Overview of Current MIGS Procedures Commercialized and in Development
Investigational* Trabectome ECP iStent† Hydrus ELT Cypass Aquesys Schlemm’s Canal Schlemm’s Canal Cycloablation Suprachoroidal Space Subconjunctival Space Not FDA Approved † Trademarks are the property of their respective owner. Ike K. Ahmed, MD EXP11732SK

7 Ab-Interno MIGS Pathways
Subconjunctival Schlemm’s Canal Suprachoroidal IOP Drop More Potent Moderate Risk Slightly More Lowest Risk Low Ease of Use Easy to Perform +/- Gonio Somewhat more Difficult Requires Gonio View Easiest to Perform Potential Issues ?Bleb Issues ?Episcleral Healing ?Hypotony ?Uncertainty of Placement ?EVP Floor ?Distal Outflow Status ?Angle Bleeding ?Variable IOP Drop ?Fibrosis in SCS Other Features Familiarity Ability to modulate postop healing Physiologic ?Titratable Potential Ready for Primetime? EXP11732SK

8 Patient Profiles: New Procedures
Trab-type Procedures EX-PRESS® Device Moderate-advanced disease Progressing normal pressure glaucoma Open Angle Low IOP target (i.e., <13mmHg) Intolerant to meds and failed SLT/ALT Question 3 Ike K. Ahmed, MD Source: EX-PRESS® glaucoma filtration device package insert EXP11732SK

9 Glaucoma Surgery Has traditionally been all about efficacy
Serious safety issues have promoted evolutionary improvements Ike K. Ahmed, MD EXP11732SK

10 Evolution of the Guarded Filtration Procedure
Wound healing strategies Suture tension & laser suture lysis Fornix-based flaps Non-penetrating approaches EX-PRESS® glaucoma filtration device Enhanced Safety Predictability Maintain efficacy Question 2 Ike K. Ahmed, MD EXP11732SK

11 What Differentiates one Filter from the Next in My Experience
Intraoperative Postoperative AC shallowing Tissue trauma Bleeding Length of procedure Hypotony Shallow/flat AC Choroidals Hyphema Bleb leak Bleb encapsulation Bleb dysthesia IOP control Visual recovery Postop interventions EXP11732SK

12 EX-PRESS® Glaucoma Filtration Device A Limbal Aqueous Device
Made of rigid 316LVM stainless steel – same as cardiac stents < 3mm long Internal lumen size – 50µm/200µm Biocompatible MRI of the head is permitted, however not recommended, in the first two weeks post implantation. Source: EX-PRESS® glaucoma filtration device package insert A Nyska, Y. Glovinsky, M. Belkin, and Y. Epstein. Biocompatibility of the EX-PRESS® miniature glaucoma drainage implant. J Glaucoma Jun; 12(3):275-80 P-50 EXP11732SK

13 EX-PRESS® Device = Trabeculectomy
Potent IOP lowering1 Requires scleral flap for additional flow control Although not as critical Requires functioning bleb, control of episcleral fibrosis Conjunctival health a factor Wound healing modulation 1) P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with EX-PRESS® miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma Jan; 16:14-19. Ike K. Ahmed, MD EXP11732SK

14 EX-PRESS® Device > Trabeculectomy
No iridectomy required Intraoperative maintenance of anterior chamber Additional fluidic restriction (50um lumen) Consistency Quieter eyes in early postoperative period1 Avoidance of intraoperative malignant glaucoma or choroidals1 Reduction of early postoperative hypotony1 P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with EX-PRESS® miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma Jan; 16:14-19. Ike K. Ahmed, MD EXP11732SK

15 EX-PRESS® Device Rationale & Transition
Hit low IOP target1,2 Enhanced predictability1 Minimize tissue disruption Improved safety1 Quieter postoperative course1 Quicker visual recovery2 Reduction of postop visits2 Improved bleb morphology2 1) Maris PJ et al., J Glaucoma 2007 2) Good TJ, Kahook MY, AJO 2011 Ike K. Ahmed, MD EXP11732SK

16 On-Label Indications (US)
Open angle glaucoma Failed medical and laser/surgical therapy Anatomical factors Scleral thickness Angle anatomy Earlier and earlier use Ike K. Ahmed, MD EXP11732SK

17 EX-PRESS® Device Technique Pearls
Anatomical landmarks Scleral flap design and thickness Device entry and angulation Postoperative bleb management Ike K. Ahmed, MD EXP11732SK

18 Surgical Limbal Anatomy
Cornea Blue-zone Scleral Spur Sclera EXP11732SK

19 AC Entry Entry should be just at anterior aspect of scleral spur, at posterior aspect of the limbal blue zone. EXP11732SK

20 Planning Scleral Flap Position & Size

21 Identify Surgical Limbus
Planned entry point for EX-PRESS® Device EXP11732SK

22 EXP11732SK

23 3.5x2.5 mm Scleral Flap 1/2mm anterior gap to prevent excessive device compression 0.5 1.0 1.0 2.5 1.0 3.5 Ensure adequate flap overlap lateral and posterior to EX-PRESS® device to allow control of aqueous flow EXP11732SK

24 EXP11732SK

25 Enter at anterior scleral spur/posterior blue zone
Parallel to iris plane - aided by rotation of eye downwards EXP11732SK

26 Parallel to Iris ?look with naked eye? EXP11732SK

27 EXP11732SK

28 Postop Management Bleb management Laser suture lysis Needling Steroids
Ike K. Ahmed, MD EXP11732SK

29 EX-PRESS® Glaucoma Filtration Device
An evolutionary improvement in trabeculectomy Smaller incision, more standardized Patient selection is much the same, although with improvement in safety and reproducibility, may be slightly broader (earlier intervention) Retains high efficacy In my hands/in my experience Ike K. Ahmed, MD EXP11732SK

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