EXP11677SK. Financial Disclosure. None to be Declared EXP11677SK

Transcription

1 Financial Disclosure None to be Declared

2 Presentation overview Glaucoma Surgical History Complications of trabeculectomy Express Device Specifications Surgical Steps Clinical advantages, indications and contraindications Conclusion Glaucoma Surgical history 1856 : von Graefe discovered that iridectomy as an effective surgical method for acute glaucoma treatment.

3 Glaucoma Surgical history 1958, De Wecker presented sclerotomy as a procedure for chronic glaucoma. Glaucoma Surgical history 1900, Fuchs recognized the correlation between the cyclodialsys and hypotony, internal filtration (cyclodialysis) was developed.

4 Glaucoma Surgical history 1966 Molteno implant for complicated cases Glaucoma Surgical history Trabeculectomy becomes gold standard Trabeculectomy remains gold standard Trabeculectomy is still considered the gold standard yet complications are still common

5 Complications of Trabeculectomy Early complications Wound leak Shallow or flat anterior chamber Hyphema Choroidal effusion Malignant glaucoma Suprachoroidal hemorrhage Decompression retinopathy Late complications Dysesthesia Encapsulated bleb Cystoid macular edema Endophthalmitis/blebitis Chronic or recurrent iritis Iris prolapse Retinal detachment Complications of Trabeculectomy Bleeding

6 Complications of Trabeculectomy Leaking bleb Complications of Trabeculectomy Flat Anterior chamber

7 Complications of Trabeculectomy Multiple suturing Complications of Trabeculectomy Hypotony

8 Complications of Trabeculectomy Choroidal effusion Express Device Specifications

9 What is the EX-PRESS Glaucoma Filtration Device FDA approved <3 mm surgical stainless steel implant. Reduces intraocular pressure by diverting the aqueous humor from the anterior chamber to the subconjunctival space. Implanted under a scleral flap with no tissue removal. Post-op aqueous outflow is controlled by the consistent lumen size and the scleral flap. The EX-PRESS device is MRI conditional safe. Source: EX-PRESS Glaucoma Filtration Device package insert Express Device Specifications

10 EX-PRESS Device P Model Vertical Channel for Posterior Flow External lumen 400µm Internal lumen size 50µm Device length Tip shape Back plate shape Pre-incision needle 2.64 mm Decreased bevel angle Vertical channel 25G EX-PRESS Glaucoma Filtration Device Step by Step

11 EX-PRESS Glaucoma Filtration Device Step by Step Create 40-50% depth scleral flap. EX-PRESS Glaucoma Filtration Device Step by Step Create pre-incision (25g-26g needle). Insertion point at lower end of the blue-grey zone. Always enter parallel to iris!

12 EX-PRESS Glaucoma Filtration Device Step by Step Insert device through pre-incision site with tip pointed lightly downward. Grasp sclera for good counter-traction with 0.12 forceps in off-hand. EX-PRESS Glaucoma Filtration Device Step by Step After device has been inserted, slide finger back on injector to feel trigger button. Push directly downward for a soft release.

13 EX-PRESS Glaucoma Filtration Device Step by Step Suture to filterate the flow EX-PRESS Glaucoma Filtration Device Step by Step Verify device position and aqueous outflow.

14 EX-PRESS Glaucoma Filtration Device Step by Step EX-PRESS Glaucoma Filtration Device Video Ike Ahmed, MD 2011 ASCRS LIVE Surgery

15 Clinical advantages, indications and contraindications EX-PRESS Device Features and Benefits Predictable and reproducible Minimally invasive Consistent lumen Controlled flow Clinical advantages, indications and contraindications EX-PRESS Device Clinical Advantages* Minimally penetrating glaucoma surgery Well over 100,000 implantations worldwide Eliminates the need for a sclerectomy and iridectomy Combining benefits: IOP lowering efficacy similar to trabeculectomy* Lower risk of complications than trabeculectomy*

16 Clinical advantages, indications and contraindications Indications for Surgery EX-PRESS Device Indications* OAG inadequately controlled by medical treatment Pseudophakic / aphakic candidates for filtration surgery Combined cataract and glaucoma Failed previous glaucoma surgery Acute / chronic NAG aphakic or pseudophakic Uveitic glaucoma once inflammation controlled Traumatic glaucoma once inflammation resolved NVG in conjunction with AVASTIN*/LUCENTIS** *INDICATIONS FOR USE :The EX-PRESS Glaucoma Filtration Device is indicated as a treatment for patients suffering from glaucoma, and for whom there is an indication, according to the physician s judgment, for filtering surgery. **Trademarks are the property of their respective owners.

17 EX-PRESS Device Contraindications* Congenital glaucoma Chronic/Acute ACG Microphthalmia *CONTRADICIONS: The implantation of the EX-PRESS Glaucoma Filtration 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. Patient diagnosed with angle closure glaucoma. 5-years Efficacy and Safety Analysis of the EX-PRESS Device vs. Trabeculectomy IOP Success rate Without IOP Medication IOP 15 mmhg EX-PRESS Trab p value Device Year % 51.3 % 0.01 Year % 48.7 % Year % 38.5 % 0.01 Year % 46.2% 0.17 Year % 46.2% 0.26 Without IOP Medication IOP 18 mmhg EX-PRESS Trab p value Device Year % 61.5 % 0.01 Year % 51.3 % 0.02 Year % 41.0 % 0.02 Year % 46.2% 0.11 Year % 46.2% patients in each group EX-PRESS device provided better IOP control vs. trabeculectomy during the first 3 years EX-PRESS device Patients had less IOP controlling medications and needed fewer surgical interventions compared with trabeculectomy Overall, EX-PRESS device implantations are more effective than standard trabeculectomy for the treatment of medically uncontrolled primary open angle glaucoma during first 3 years De Jong L, Lafuma A, Aguadé AS, Berdeaux G, Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma. Clinical Ophthalmology 2011:

18 Dahan et al Comparison of trabeculectomy and EX-PRESS implantation in fellow eye of the same patient: a prospective randomized study Dahan et al Comparison of trabeculectomy and EX-PRESS implantation in fellow eye of the same patient: a prospective randomized study; EYE February 2012 Similar efficacy and better safety compared with trabeculectomy 100 eyes; Fu=12months * 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.

19 EX-PRESS Under Scleral Flap Alone or Combined with Phaco Cataract Surgery Success Rate - Survival Analysis Retrospective chart review of 345 eyes Significant reduction in IOP and medications EX-PRESS is effective and well tolerated for long term both alone and combined with cataract procedure Pre Pre baseline baseline 3 yrs 3 yrs 3.5 yrs 3.5 yrs Kanner EM, Netland PA, Sarkisian SR Jr, Du H. EX-PRESS miniature glaucoma device implanted under a scleral flap alone or combined with phacoemulsification cataract surgery J Glaucoma 2009 Aug;18(6): Conclusion EX-PRESS Glaucoma Filtration Device Brings predictability To filtration surgery

20 Conclusion EX-PRESS Glaucoma Filtration Device controlled drainage helps regulate IOP resulting in less hypotony Reduced surgical trauma results in less inflammation and more rapid recovery IOP MIGS Expr Trab meds lasers Glaucoma severity

21 Conclusion Surgical glaucoma continues to Evolve The aims of the treatment to have Better predictability Better reducibility Better tolerability Better access to general ophthalmologist Better outcome Better safety profile Other Novel devices/procedures Deep sclerectomy/canaloplasty Glaukos micropypass stenting Trabecutome Cypass Aquisis Endocyclophotocoagulation Transcend

22 Deep sclerectomy Glaukos microbypass stent

23 Cypass suprachoroidal shunt Endocyclophotocoagulation