EyeWorld India June 2013 Issue

June 2013 27 EWAP FEAturE TECNIS ® Monofocal Intraocular Lens (IOL) Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Precautions : Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or in temperatures over 45°C. Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece lens was macular edema, which occurred at a rate of 3.3%. Other reported reactions, occurring in less than 1% of patients, were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic). TECNIS ® Multifocal 1-Piece Intraocular Lens (IOL) Warnings: Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. Some visual effects associated with multifocal IOLs may be expected because of the superposition of focused and unfocused images. These may include a perception of halos/glare around lights under nighttime conditions. It is expected that, in a small percentage of patients, the observation of such phenomena will be annoying and may be perceived as a hindrance, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient will request removal of the multifocal IOL. Under low-contrast conditions, contrast sensitivity is reduced with a multifocal lens compared with a monofocal lens. Therefore, patients with multifocal lenses should exercise caution when driving at night or in poor-visibility conditions. Patients with a predicted postoperative astigmatism >1.0 D may not be suitable candidates for multifocal IOL implantation since they may not fully benefit from a multifocal IOL in terms of potential spectacle independence. Care should be taken to achieve centration, as lens decentration may result in patients experiencing visual disturbances, particularly in patients with large pupils under mesopic conditions. Precautions: The central one millimeter area of the lens creates a far image focus; therefore, patients with abnormally small pupils (~1mm) should achieve, at a minimum, the prescribed distance vision under photopic conditions; however, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near-vision benefit. Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended. In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements, as two different wavefronts are produced (one will be in focus [either far or near], and the other will be out of focus); therefore, incorrect interpretation of the wavefront measurements is possible. The long-term effects of IOL implantation have not been determined; therefore, implant patients should be monitored postoperatively on a regular basis. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively. Do not resterilize or autoclave. Use only sterile irrigating solutions such as balanced salt solution or sterile normal saline. Do not store in direct sunlight or in temperatures over 45°C. Emmetropia should be targeted, as this lens is designed for optimum visual performance when emmetropia is achieved. Adverse Events: The most frequently reported adverse event that occurred during the clinical trial of the TECNIS ® Multifocal IOL was surgical reintervention, which occurred at a rate of 3.7% (lens-related: 0.6%; non-lens- related: 3.2%). Surgical reintervention included lens exchange, retinal repair, iris prolapse/wound repair, trabeculectomy, lens repositioning and lens removal due to patient dissatisfaction. The second most frequent adverse event was macular edema, which occurred at a rate of 2.6%. Other reported reactions were hypopyon and endophthalmitis, each occurring at a rate of 0.3%. Caution: Federal law restricts these devices to sale by or on the order of a physician. Do not use the lens if the package has been damaged. The sterility of the lens may have been compromised. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. Important Safety Information 2013.02.05-CT6339 ultrasound phacoemulsification it is three months. LCE does not change the shape coefficient of the corneal endothelial cells and doesn’t decrease hexagonality postop. This is an important criterion of technology safety that is proven on a cell level. Total corneal endothelial cell loss after LCE is two-fold less compared to ultrasound. Advantages of LCE as a more advanced and sparing surgical technology are evident, especially when managing difficult cases— nuclei of high density and complicated cataracts; diabetes, avitreal eye, pseudoexfoliation syndrome, lens subluxation, intumescent and hypermature cataracts, and compromised corneas. The objective proof of the statement is in statistically significant differences found in studies of ocular hydrodynamics, ciliary body UBM, corneal pachymetry, electrophysiology, specular microscopy, scanning and transmission electron microscopy. There is no doubt that laser energy is the future of cataract surgery and its progress. New technology of femtosecond laser- assisted phacoemulsification and our technology of 1.44 mcm Nd YAG laser cataract extraction have no mutual contradictions. On the contrary, when juxtaposed, these two methods will effectively supplement each other. Such an integration will yield 100% abolishment of the unsafe energy of ultrasound. We will have entirely laser technology in cataract surgery. We plan to join these two approaches. EWAP Editors’ note: The sources have financial interests with their respective companies. Contact information Kopayeva : vgkopayeva@yandex.ru Vialova : evialova@gmail.com Laser - from page 24 AMO, Santa Ana, Calif., USA). Surgery was performed on the left eye first, with the right eye done two weeks later. The procedure for placing the femtosecond relaxing incisions was similar for each eye. The flat axis was marked for proper alignment during the femtosecond incisions. Intrastromal incision creation with the femtosecond was planned to allow more careful titration of the effect. The suction ring for the iFS femtosecond laser was placed. Sub- Bowman’s membrane arcuate cuts were made with 30 degrees of tissue cut at an 8.5-mm optical zone at the 130-degree and 210-degree meridians in the right eye and at the 48-degree and 228-degree meridians in the left eye. A depth in glass of –60 was used to cut just below Bowman’s membrane. A side-cut angle of 75 degrees was used. The arcuate incisions were opened partially for 20 degrees in each incision using a Sinskey hook. At three months post-op, the patient had 20/20 uncorrected distance vision in the right eye with a refraction of –0.50 +0.25 x 115. In the left eye, his uncorrected distance visual acuity was 20/25 and near J3. With a refraction of –1.00 +0.75 x 167, he saw 20/20. He was functioning well with only occasional use of reading glasses. This case shows the usefulness of the femtosecond laser in creating corneal arcuate incisions in a patient with corneal shape problems. This patient achieved improved function after the procedure. Corneal relaxing incisions have become a very useful part of corneal surgery, especially with the increased accuracy, safety, and titratability afforded with the femtosecond laser. EWAP Editors’ note: Dr. Hardten is in practice at Minnesota Eye, Minneapolis. He has financial interests with AMO. Contact information Hardten : drhardten@mneye.com