Endoscopic Photocoagulation

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1 Endoscopic Photocoagulation Making a Difference.

2 Empowerm ECP transcends prior technical limitations and offers a bright, new solution for the treatment of glaucoma. Endoscopic CycloPhotocoagulation (ECP) is a surgical approach to glaucoma management that employs light endoscopy and visualized laser application. Five patents combine the modalities of light, image, and laser in a single, powerful 20Ga instrument. The result is the selective ablation of pigmented, ciliary epithelium tissue, with minimal impact to surrounding, nontargeted anatomy. Remarkably, all forms of glaucoma can be effectively treated with this technology. With continuous, direct imaging of the ciliary processes, controlled laser energy is delivered; IOP is lowered and aqueous production is controlled, with superior long-term results. The compact E2 system contains a video camera, xenon light source, and a semiconductor diode laser tuned to 810nm wavelength. This power console features adjustable laser output, pulse width, light and aiming beam intensity. Light Image Laser M Uram, MD, MPH holds multiple patents for endoscopic technologies, with financial interest in EndoOptiks, Inc. and its products. 110 panoramic wide field illumination delivers maximum intraocular visibility with a 175Watt Xenon light source. 10K pixel resolution allows clear imaging of ocular tissues from the anterior or posterior segment. Precise, 810nm, 2.0Watt diode laser energy, in pulsed or continuous mode, is delivered to targeted intraocular tissues.

3 Cataract ECPs greatest worth is its ability to reduce or eliminate glaucoma medications and thereby improve compliance Richard J. Mackool, MD Cataract Surgeon ent Light Image Laser Glaucoma...you can use the endoscope to visualize the angle directly and treat it. Stanley J. Berke, MD, FACS Glaucoma Specialist The comprehensive armamentarium of endoscopes, span the need from simple illumination, to laserimaging fibers - for anterior ECP applications as well as posterior PRP delivery. DCR probes are also provided with the higher intensity 12Watt power console. Optional consoles allow modular flexibility of light, image, and/or laser power selection. This powerful new technology has been embraced by ophthalmologists across specialties. Pediatric Retina The advantage of being able to see each individual ciliary process, as they are treated, is tremendous. David A. Plager, MD Pediatric Ophthalmologist ECP employs a triple function micro endoscope to provide heretofore impossible intraocular visualization Martin Uram, MD, MPH Retina Specialist Image Light Laser System Simplicity Sequential organization of system settings and parameters, and backlighted LCD front panel, makes set up and operation rapid and intuitive.

4 In our patients with controlled glaucoma and cataracts, combined ECP with phaco IOL insertion is my treatment RJ Mackool, MD of choice. In a combined phacoemulsification/ecp procedure, an existing clear corneal or limbal incision is sufficient to accommodate the 20Ga endoprobe. In a stand-alone ECP case, the ciliary processes may be approached from a limbal or a pars plana incision. From this single entry, anatomy is accurately identified, and between 180 to 200 of ciliary processes can effectively be reached; a secondary incision will accommodate a full 270 to 360 treatment. Versatility & Direct, continuously monitored visualization, with aiming beam precision, produces repeatable, titratable shrinkage of targeted tissues. Most impressive, beyond the incremental benefits of the ECP procedure, endoscopy allows the accurate assessment of: zonular dehiscence, capsular bag integrity, residual cortical material, intended haptic placement, and anterior hemorrhage. Clearly, this capability should only enhance clinical outcomes. Anybody who can do phaco can learn ECP in a heartbeat. You can learn to use the probe to paint the ciliary processes in a continuous motion. Combined with phaco, ECP takes an extra 2 to 5 minutes. This 2-5 minute, reimbursed technique is ideal for patients with medically controlled glaucoma. Intended surgical results lower intraocular pressure (IOP) longterm, reduce required patient medications (minimizing compliance issues), and retard progression of the glaucomatous condition. "All of our procedures are done through the clear cornea. In the phakic patient, a sodium hyaluronate viscoelastic is injected between the iris and anterior lens surface to broaden access to the ciliary processes." DA Plager, MD Pediatric Ophthalmologist "I treat some eyes through the pars plana, with deranged anterior segment anatomy, where there might be a lot of synechiae between the iris and the lens capsule. RJ Mackool, MD Clear Corneal Entry Pars Plana Approach RJ Mackool, MD Target Approach Our goal is to provide the best patient care in our practice. If I can perform advanced phaco and reduce my patients dependency on glaucoma medications, I have succeeded to this end. Stephen B Wiles, MD Cataract Surgeon Clear corneal entry, through the existing phaco wound, allows treatment of Phakic, Pseudophakic, or Aphakic eyes. Laser delivery occurs either over, or through, the capsular bag. Pars plana approach may be employed, combined with Vitreous surgery, for Pseudophakic or Aphakic patients.

5 Control I do ECP on every one of my cataract patients who is also on glaucoma medication, because it works so well... through a single incision I can initially treat approximately 210 o to 240 o of ciliary processes. MS McFarland, MD Angle, Iris, Lens I also use the endoscope during procedures in which I wish to examine the ciliary sulcus. Such cases include those with dislocated or decentered IOLs, or possible retained lens fragments and/or abnormalities of the capsule/zonules. RJ Mackool, MD Haptic in the Bag Residual Lens Fragments Combined with phaco, ECP takes an extra two minutes. The endoscope is also a great teaching tool... providing a virtual tour of the eye. Alan B Aker, MD Cataract Surgeon Retina at Ora Serrata Unlike transscleral cylodestructive procedures, the surgeon can see the ciliary processes and therefore can titrate laser delivery properly. M Uram, MD, MPH 180 o -360 o Range Haptic Piercing Ciliary Body Posterior View of Processes Dropped Nucleus Another use of the endoscope is as a visualization tool in any patient with a cloudy cornea... to see the status of the optic nerve and retina. SJ Berke, MD, FACS Glaucoma Specialist Laser Treated Processes AC-IOL Piercing Iris Thickened Zonules in Pseudoexfoliation Diabetic Retinal Hemorrhage Application/Impact IOL/Haptic Position Endoscopic Discovery Retina Visually titratable results are achieved, from 180 o to 360 o, as processes blanch and shrink to desired composition. Pulsed laser application delivers selective ciliary process treatment. Continuous laser mode allows for rapid ablation, in a 'painting' technique. Proper IOL and lens haptic placement is easily confirmed using simple endoscopic technique. Ophthalmic Endoscopy broadens diagnostic assessment and surgical treatment across specialties. Posterior segment views provide clear imaging of the macula and optic nerve head, in addition to post-operative retinal integrity at the ora serrata.

6 Successful surgical techniques are measured by compelling long term, clinical findings. ECP is supported by more than five years of data. When compared to all other surgical techniques for glaucoma management, ECP meets and exceeds the long term goal for reduced IOP and topical medications. Even in studies that compared 'phaco alone' to 'phaco with ECP', the combined procedure showed no higher complication rates, while intended, long-term, positive results were significantly elevated. Relative to traditional transscleral cyclodestructive approaches, intraocular ECP has repeatedly earned marked distinction. Measured The ideal patient for a combined procedure is one who is controlled, or at least marginally controlled with glaucoma medications... We should never underestimate how much patients desire to get off one or more of their glaucoma medications. RJ Mackool, MD Without incidence of CME or major complications, ECP reduced IOP 38% further than Phaco surgery alone. In addition, 87% of these patients benefited from reduced medications, while more than 60% no longer needed any pharmaceutical management. You can t do phaco expecting that pressures will be lowered. SJ Berke, MD, FACS ECP mean CONTROL mean f/u = 25 mo f/u = 44 mo Ps Mean change in IOP (mmhg) Decreased Meds (%) Same (%) Increased Meds (%) No meds (%) CME (%) 0 0 Major complications (%) 0 0 Mackool: ECP vs. Phaco Alone I do a combined procedure on every cataract patient on glaucoma medication... If I can eliminate one or two drops... a beta-blocker... (patients) just feel better. It s a really nice thing you can do for your patients. Alan B. Aker, MD 180 ablation resulted in a 15% decrease in IOP and 68% reduction in medications, without visual loss or major complications Berke, SJ., et al. J Glaucoma 2000; 9:1. 25 eyes, mean f/u 11 months Mean Ablation 180 Mean Decrease IOP 15% Mean Reduction of Meds 68% Post-op Visual Loss 0% Major Complications 0 Berke: ECP Study I manage my ECP patients just as I do a postoperative cataract. I see them at one day and one week, and probably 90% of them are cell free at two weeks. MS McFarland, MD Histology showing selective ablation of the ciliary epithelium. Clinical studies and scientific data are available upon request.

7 Without the high failure rates associated with transscleral techniques, ECP is not reserved for end-stage glaucoma. Treatments have proven far superior in accurately isolating ciliary processes, discretely ablating ciliary epithelium, and achieving desired results - without missing, or over/under treating the target tissue. Further, devastating complication rates are lowest following ECP, and postoperative patient management is facilitated relative to traditional glaucoma procedures. Results IOP (mm Hg) NVG APH/PS Phakic POAG Combined Congenital With ECP, (reduced pressure...) usually happens during the first six to eight weeks. A seven year follow-up study shows... few patients decompensate after the second year, as would be expected with filtration procedures. M Uram, MD, MPH Follow-Up (months) Long Term IOP Control Remarkably, all forms of glaucoma respond to ECP with comparable, sustained results. OAG OAG with CACG CACG with NVG PED GL Phaco & Uncontrolled Phaco & Controlled Failed Surgery Failed Surgery Glaucoma Surgery Glaucoma Surgery TRAB 90% 50% 50% 30% NA < 50% 70% NA TUBE NA 50-70% 50-70% 50-70% 50-70% < 50% NA NA TSCPC NA NA 30-50% 30-50% 30-50% < 50% NA NA ECP 90% 90% 90% 90% 90% > 50% 90% + 90% Uram: IOP Control - Results per Procedure In no way can ECP be compared with true cyclodestructive techniques. This distinction exists in patient selection, patient tolerance, clinical complications, and long term results. SB Wiles, MD ECP proves more efficacious in reducing IOP, over 24 months, than trabeculectomy, tube implants, and transscleral treatments. Minor Devastating Visual Endophthalmitis Delayed Operative Intensity of Post Complications Complications Acuity Loss Failures Time (1-4) Op Care (1-4) TRAB 10-50% 5-10% 5-10% 1%/yr > 50% 3 4 TUBE 30-50% 30% ~10% 1% ~10-30% 4 3 TSCPC > 50% 30% > 40% NA ~ 40% 2 2 ECP 3-8% < 1% < 1% 0% 0-5% 1 1 Uram: Complications per Procedure Relative to these same procedures, ECP produced the smallest percentage of minor complications, visual acuity loss, or devastating complications.... if the patient has good visual potential, I use the endolaser, because I think we risk decreasing their vision with a transscleral approach. SJ Berke, MD There is no comparison (between ECP and cyclodestructive techniques). I personally would not do a transscleral laser or cyclocryo procedure. RJ Mackool, MD

8 Endo Optiks System Components Laser and Endoscopy Systems OME2000 E2 Compact Microprobe Laser and Endoscopy System OME3000 E3 Compact Microprobe High Power Laser and Endoscopy System OME4000 E4 Endoscopy System OME Watt Diode Laser OME1600 LX - Mini Light Source (Metal Halide) Light Image Laser Endoscopes, Probes and Fibers Light Image Laser E2 E3 E4 12W OME200SMAE Ophth. Laser Endoscope - Semi-Disposable (1/ea) OME200SMAX Ophth. Laser Endoscope with Custom Laser Connector - Semi-Disposable (1/ea) OME200L Ophth. Endoscope - Light and Camera Semi-Disposable (1/ea) VPH200 Endophotocoagulation Probes Disposable, Single Use (5/bx) VPH200A Endophotocoagulation Probe Reusable, Autoclavable (1/ea) VP Gauge Illumination Probe Disposable, Single Use (5/bx) OME20LA Illuminated Laser Probe, Wide Field Reusable, Autoclavable (1/ea) VP200W Wide Field Illumination Probe Reusable, Autoclavable (1/ea) VP5330C Disposable Laser Fiber (5/bx) VP5330TR Disposable Transcleral Laser Fiber (5/bx) Accessories E2 E3 E4 12W OME300Z Video Adapter Upgrade MON001 Sony Video Monitor - 13" CT001 Custom Operating Room System Cart OME100LF Diode Laser Safety Filter for Zeiss Microscope OME100LFM Diode Laser Safety Filter for Moller Microscope OME100LFW Diode Laser Safety Filter for Wilde Microscope LG001 Diode Laser Safety Goggles VP6200 Sterilization Tray FC Flight Case with Wheels & Telescoping Handle Flight Case with Wheels VP5120 Endoscopic Blade Console Compatibilty Typical setup of E2 for ECP Available Modalities Medtronic Solan 6743 Southpoint Drive North, Jacksonville, Florida USA Fax All products are manufactured by EndoOptiks, Inc., and exclusively distributed by Medtronic Solan. Clinical studies and scientific data are available upon request. M Uram, MD, MPH holds multiple patents for Endoscopic Technologies, with financial interest in EndoOptiks, Inc. and its products

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