EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/115557
March 2013 DisCoVisc® Ophthalmic Viscosurgical Device (Sodium Chondroitin Sulfate – Sodium Hyaluronate). Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Phakic IOL explantation safe, reversible approach by Erin L. Boyle EyeWorld Senior Staff Writer Description: DisCoVisc® Ophthalmic Viscosurgical Device has an intermediate cohesive/dispersive index (CDI) and can best be described as the first viscous dispersive viscoelastic and is optimized for the entire surgical procedure. Indications: DisCoVisc® Ophthalmic Viscosurgical Device is indicated for use during surgery in the anterior segment of the eye. It is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues and to manipulate tissues during surgery. It may also be used to coat intraocular lenses and instruments during cataract extraction and IOL insertion. 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: DisCoVisc® Ophthalmic Viscosurgical Device was very well tolerated in nonclinical and clinical 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 DisCoVisc® 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: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions. U.S. Patent Nos. 5,273,056; 5,876,379 and 6,051,560. Extreme pupil ovalization C linical results and refractive outcomes were promising in explanted phakic IOL cases, with cataract the most frequent cause of explantation, a study found. "Phakic IOL explantation surgery is an effective and safe procedure, and the clinical and refractive outcomes were excellent in most of the cases, and the [phakic IOL exchange, bilensectomy, or other associated refractive procedures] showed to be effective in these results," said Felipe A. Soria, M.D., Vissum Corp., Alicante, Spain. Dr. Soria gave his results at the American Academy of Ophthalmology meeting's 2012 Refractive Surgery Subspecialty Day. In an interview after the meeting, Dr. Soria elaborated on the details of the study, conducted and directed at Vissum Corp. in the Alicante, Spain clinic, by Jorge Alió, M.D., Ph.D., founder and medical director, Vissum Corp. They are collecting information on explanted phakic IOLs from ophthalmological centers in Spain in a shared investigational project. The complete explantation procedures performed were: simple explantation surgery, bilensectomy, phakic IOL exchange, and phakic IOL exchange and penetrating keratoplasty. "As far as we know, it's the largest case study ever reported, so it makes the study highly reliable to evaluate the outcomes of phakic IOL explantation," Dr. Soria said at Subspecialty Day. Afterward, he said the key outcome found in the study was "clinical results and refractive outcomes were excellent in most of the cases, offering a good predictability." Main reason The main reason for explantation was cataract, followed by endothe© 2013 Novartis 1/13 VIS12724JAD-PI Cataract formation PIOL decentration Source (all): Felipe Soria, M.D. lial cell loss and other complications, Dr. Soria said. He was surprised by cataract being the most common reason, but this finding could be of great help to ophthalmologists. "Phakic IOL is an extremely effective procedure where we can offer a patient decades of excellent visual outcomes; despite all of this, at some point, this IOL will need to be explanted. Hopefully [it will not be explanted] because of a complication but for cataract age-related formation," he said. "Knowing about this study and that most of the surgeries performed were successful in terms of refractive and safety outcomes, we can approach explanation surgeries of any cause with scientific evidence for our patients and for us," Dr. Soria said. Lenses In the consecutive, retrospective, observational, multicenter series, 140 cases of phakic IOL explanations in Spain were reviewed. A total of 61.4% of four types of angle-supported IOLs were explanted; 30.8% of two types of posterior chamber IOLs were explanted; and 7.8% of three types of iris-fixated IOLs were explanted. The specific phakic IOLs studied were the following for angle-supported IOLs: Baikoff ZB, ZB5M (Domilens, Lyon, France), Kelman Duet IOL (Tekia, Irvine, Calif.), ZSAL-4 (Morcher, Stuttgart, Germany), and Phakic 6 IOL (Ophthalmic Innovations International, Ontario, Calif.). For posterior chamber IOLs, the lenses studied were: ICL, models V2–V4 (STAAR Surgical, Monrovia, Calif.) and the Phakic Refractive Lens (PRL, Irvine, Calif.). In iris-fixated IOLs, the lenses studied were: the Artisan irisfixated lens (Ophtec BV, Groningen, the Netherlands), the Verisyse phakic IOL (Abbott Medical Optics, Santa Ana, Calif.), and the Artiflex foldable iris-fixated lens (Ophtec BV). In the interview, Dr. Soria said he did not see an issue with the fact that some of the phakic IOLs studied are no longer available on the market. "I believe it is totally the opposite," he said. "We saw many complications that obviously ended in explantation. Nowadays, biomaterial has improved in phakic IOLs, and the technology that we are using gives us more specifics and detailed morphology of the eye that allows us better indications (measuring the anterior chamber from epithelium to the anterior iris, measuring the angle, measuring the angle-angle distance and sulcus-sulcus distance), therefore our complications are much lower, but still we have to manage them." He said this idea is the main concept of the study: Regardless of what phakic IOL is now implanted, the explantation potential is lower, especially in cases that can be managed in terms of safety and refractive outcomes. Additionally, Dr. Soria said the study adds to the discussion of phakic IOL explantation a "detailed understanding of phakic IOL complications and the mechanisms for these complications according to their different anatomical positions." It also "highlights the surgical technique of explantation for different anatomical types of phakic IOLs available on the market," he said. EW Editors' note: Dr. Soria has no financial interests related to this article. Contact information Alió: jlalio@vissum.com Soria: soriafelipe.md@gmail.com