Eyeworld Daily News

EW SHOW DAILY 6 ASCRS News Saturday, April 14, 2018 © 2015 Novartis 6/15 VIS15002JAD DUOVISC ® OVD IMPORTANT PRODUCT INFORMATION DESCRIPTION: DUOVISC ® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DUOVISC ® Viscoelastic System consists of VISCOAT ® Ophthalmic Viscosurgical Device and PROVISC ® Ophthalmic Viscosurgical Device. CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician. DESCRIPTION: VISCOAT ® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device INDICATIONS: VISCOAT ® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT ® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. WARNINGS: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury. PRECAUTIONS: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material. ADVERSE REACTIONS: VISCOAT ® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT ® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings and precautions. DESCRIPTION: PROVISC ® (Sodium Hyaluronate) Ophthalmic Viscosurgical Device INDICATIONS: PROVISC ® OVD is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push back the vitreous face and prevent formation of a flat chamber during surgery. PRECAUTIONS: Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that PROVISC ® OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate is a highly purified biological polymer, the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury. ADVERSE REACTIONS: Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise in intraocular pressure. It is therefore recommended that PROVISC ® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. ATTENTION: Please refer to the directions for use for a complete listing of indications, warnings and precautions. Advancing CATARACT SURGERY DuoVisc ® VISCOELASTIC SYSTEM VIS15002JAD_PI_EWDN.indd 1 4/6/18 2:03 PM Glaucoma continued from page 1 blebs, and tube shunts, he said, are squeezing out trabeculectomy proce- dures. Many surgeons have stopped doing trabeculectomy procedures, which Dr. Ahmed said is a sign, and we're seeing trials that compare subconjunctival MIGS procedures with outcomes that rival trabeculec- tomies in pressure lowering but with better ease of use, he added. He also pointed to the market data and said, "If trabs were so great, we wouldn't see a tiny section of the market being done." Dr. Ahmed didn't deny that a great surgeon could certainly do a great trabeculectomy procedure, but he said the need to follow the patient every few days, monitoring wound healing to determine the best time for suture lysis, is onerous. Similar to cataract surgery, which switched from a large inci- sion with sutures to small incision, sutureless surgery, so too, Dr. Ahmed said, is there a migration in glauco- ma to less invasive procedures. "The 1960s called, they want your surgery back," Dr. Ahmed quipped to Dr. Rhee. "There is a war out there, guys; it's a battle for glau- coma surgery supremacy." "Enough with the challenger, enough with the foreigner that's come into our land to tell us that trabs are dead," Dr. Rhee said when he stepped up to the podium. "Trab- eculectomy is alive and well, and I'll tell you why." Dr. Rhee went on to show how the field has been trying to kill trabs for 50 years and, against all odds, it's still alive. Part of that reason, Dr. Rhee explained, citing government and sales data, as well as published studies, is efficacy (trabeculectomy can get to lower pressures than MIGS, he said); trabeculectomy can be used in nearly all clinical sce- narios; trabeculectomy is cheaper than other procedures; and market data shows that trabeculectomy procedures have been sustained over decades. "Trabeculectomy is still a viable procedure, even though we have lots of different options," Dr. Rhee concluded. Ultimately, the audience agreed and voted Dr. Rhee the winner. EW Editors' note: Dr. Ahmed and Dr. Rhee have financial interests with various ophthalmic companies. continued on page 10 by Chiles Aedam R. Samaniego EyeWorld Asia-Pacific Senior Staff Writer G laucoma surgery is ef- fective in reducing IOP, provides 24-hour control, is free of problems con- cerning compliance, and is economical in terms of how much money patients will have to spend Prioritizing patient perspectives in glaucoma surgery over time. However, that isn't what patients tend to worry about. Tarek Shaarawy, MD, Geneva, Switzerland, gave the International Lecture at the 2018 Glaucoma Day on the topic of "Patient-Oriented Outcomes" for glaucoma patients. Basically, Dr. Shaarawy made the argument for reorienting the assess- ment of glaucoma to prioritize the perspective of patients. While glaucoma surgery is gen- erally effective, this fact alone is not what most informs the experience of patients. Rather, they are more concerned about the long list of potentially visually damaging com- plications, the actual experience of feeling their eyes—patients become aware of their eyes, can feel the changes made by surgery to them, feelings that significantly affect quality of life. Dr. Shaarawy drew attention to visual outcomes and issues relat- ed to bleb dysesthesia. With these particular concerns of patients in mind, he asked: Have we been un- derestimating visual loss and loss of comfort? Do emerging technologies change the rules of the game? Are we losing track of the points that are most important to patients? In creating consensus guide- lines for glaucoma treatment, Dr. Shaarawy, as part of the committee that created the guidelines, felt they had made a colossal mistake, tipping the scales toward using IOP as the primary end point. While visual acuity and visual field data were reported, at the time they thought they were "impractical as primary outcomes." Patients aren't so concerned with IOP reduction, which is for the most part imperceptible to the patient. Rather, they are more concerned about their experience of seeing, and are particularly interested in the level of comfort postop. He asked, are we giving patients the full story? He noted data that showed 56% of patients lost > two lines of best corrected visual acuity; the TVT trial showed loss of > two lines in one out of three patients, and there are consistent reports of visual loss of 18.8 to 20.4% in na- tional surveys of trabeculectomy. Meanwhile, by performing these surgical procedures, surgeons are "gifting patients with the bleb"—a hump on the otherwise perfect to- pography of the eye.

• Cover