exp11732sk. ex-press® device brief statement caution: federal law restricts this device to sale by...
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Glaucoma Surgery& The EX-PRESS® Device
Ike K. Ahmed, MDEXP11732SK
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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.
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Disclosures• Consultant (+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
Ike K. Ahmed
• Speaker Honoraria (S)– New World Medical
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Glaucoma Surgical Options
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Ike K. Ahmed, MD5
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
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Ike K. Ahmed, MD
Overview of Current MIGS Procedures Commercialized and in Development
Commercialized• Trabectome
• ECP
Investigational*• iStent†
• Hydrus• ELT• Cypass• Aquesys
Schlemm’s Canal
Schlemm’s Canal
Suprachoroidal Space
Subconjunctival Space
6
Cycloablation
•Not FDA Approved•† Trademarks are the property of their respective owner. EXP11732SK
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Subconjunctival Schlemm’s Canal Suprachoroidal IOP Drop More Potent Moderate Moderate
Risk Slightly More Lowest Risk Low
Ease of Use Easy to Perform+/- Gonio
Somewhat more DifficultRequires Gonio View
Easiest to Perform+/- Gonio
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
FamiliarityAbility to modulate
postop healingPhysiologic?Titratable Potential
Ab-Interno MIGS Pathways
Ready for Primetime?EXP11732SK
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Ike K. Ahmed, MD8
Patient Profiles: New ProceduresTrab-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
EXP11732SKSource: EX-PRESS® glaucoma filtration device package insert
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Ike K. Ahmed, MD9
Glaucoma Surgery• Has traditionally been all about efficacy• Serious safety issues have promoted
evolutionary improvements
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Ike K. Ahmed, MD10
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 SafetyPredictabilityMaintain efficacy
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What Differentiates one Filter from the Next in My Experience
Intraoperative• AC shallowing• Tissue trauma• Bleeding• Length of procedure
Postoperative• Hypotony• Shallow/flat AC• Choroidals• Hyphema• Bleb leak• Bleb encapsulation• Bleb dysthesia• IOP control• Visual recovery• Postop interventions
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EX-PRESS® Glaucoma Filtration DeviceA 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.
P-50EXP11732SK
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. 2003 Jun; 12(3):275-80
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Ike K. Ahmed, MD13
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. 2007 Jan; 16:14-19.
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Ike K. Ahmed, MD14
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
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. 2007 Jan; 16:14-19.
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Ike K. Ahmed, MD15
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 20072) Good TJ, Kahook MY, AJO 2011
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Ike K. Ahmed, MD16
On-Label Indications (US)• Open angle glaucoma• Failed medical and laser/surgical therapy
• Anatomical factors– Scleral thickness– Angle anatomy
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Ike K. Ahmed, MD
EX-PRESS® Device Technique Pearls
• Anatomical landmarks• Scleral flap design and thickness• Device entry and angulation• Postoperative bleb management
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Scleral Spur
Sclera
Blue-zone
Cornea
Surgical Limbal Anatomy
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AC Entry
Entry should be just at anterior aspect of scleral spur, at posterior aspect of the limbal blue zone.
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Planning Scleral Flap Position & Size
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Identify Surgical Limbus
Planned entry point for EX-PRESS® DeviceEXP11732SK
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3.5x2.5 mm Scleral Flap
Ensure adequate flap overlap lateral and posterior to EX-PRESS® deviceto allow control of aqueous flow
1/2mm anterior gap to prevent excessive device compression
3.5
2.5
1.0
1.0
1.0
0.5
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Enter at anterior scleral spur/posterior blue zoneParallel to iris plane - aided by rotation of eye downwards
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Parallel to Iris
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Ike K. Ahmed, MD28
Postop Management• Bleb management• Laser suture lysis• Needling• Steroids
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Ike K. Ahmed, MD29
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
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