Tecnis Symfony Receives CE Mark
Abbott Medical Optics (AMO) received the CE Mark for the Tecnis Symfony Extended Range of Vision IOL for cataract patients with presbyopia, according to a com- pany news release.
The Tecnis Symfony is the only presbyopia-correcting extended range of vision IOL designed to provide patients with increased spectacle independence and quality vision over a continuous range of distances including far, intermediate, and near, the news release said. The lens is designed to increase the distance over which an object appears in focus without sacrificing the patient’s visual clarity or contrast when compared with standard monofocal IOLs.
“With the available advances in IOL technology, many patients are not satisfied with having to wear reading glasses after cataract surgery, which is often the result when using conventional monofocal IOLs,” Gerd U. Auffarth, MD, PhD, FEBO, of Ruprecht-Karls University of Heidelberg, said in the news release. “The Tecnis Symfony Extended Range of Vision IOL enables physi- cians to offer patients a continuous range of functional vision for far, intermediate, and near distances, with reduced risk of undesired halos or glare.”
AMO has commenced a 150-patient study in Europe to evaluate quality of vision at far, intermediate, and near distances after implantation of the Tecnis bilaterally. The study will also assess both patient and surgeon satisfac- tion. Preliminary results are anticipated later this year.
AMO is also conducting a postmarket observational study including approximately 400 patients across Europe, with results expected at the end of 2014, the news release said.
Visian ICL Preloaded System Receives CE Mark
STAAR Surgical received the CE Mark for its Visian ICL Preloaded System, according to a company news release.
The Visian ICL Preloaded System reportedly reduces overall procedure time, shortens the learning curve for new surgeons to perform ICL procedures, and enables more consistent ICL delivery. The preloaded injector design incor- porates a hydrophilic coating technology, called nanoCOAT, that allows a smooth transition of the ICL through the injec- tor system to the small incision for ICL implantation and an enhanced optic design that increases the useful optic zone size. Depending on the ICL power, the optical surface could increase up to 20%, potentially enhancing night vision, the news release said. The Visian ICL CentraFlow technology is also available in this preloaded system.
“In the time and motion study done at our facility with the Visian ICL Preloaded System, lens preparation time was reduced by 68%,” Erik L. Mertens, MD, FEBOphth, Medical Director and Founder of the Medipolis Eye Centre and Co-Chief Medical Editor of CRST Europe, said in the news release. “I look forward to the availability of the Visian ICL Preloaded System. I expect this system will increase the adoption of Visian ICL use as well as add efficiencies and reproducibility to the implantation procedure.”
STAAR plans to officially launch the Visian ICL Preloaded System at the 2014 European Society of Cataract and Refractive Surgeons (ESCRS) meeting in London, the news release said.
PowerVision Completes US$30 Million Series D Funding
PowerVision, the manufacturer of the FluidVision accommodating IOL, has completed a US$30 million Series D financing round, according to a company news release. New investors Aisling Capital and Correlation Venture Partners and existing investor Venrock added US$10 million to the US$20 million closing earlier this year from PowerVision’s existing investors.
The FluidVision lens is designed to permanently restore clear vision at all distances in patients with cataracts and presbyopia. According to the company, FluidVision lenses mimic the eye’s natural accommodative process to change shape and adjust focus the way that young, healthy eyes do.
“Based on data reported to date, we believe that the FluidVision lens could become the first truly accommodat- ing IOL to hit the market and become a new standard of care for cataracts and presbyopia surgery,” Barry Cheskin, President, CEO, and Cofounder of PowerVision, said in the news release. “The FluidVision lens would eliminate that need [for reading glasses or other corrective lenses] and could provide a new option for millions of people with these conditions.”
Data from the company’s pilot study, presented at the 2013 American Society of Cataract and Refractive Surgery (ASCRS) meeting in Boston, showed that patients under- going cataract surgery who received the FluidVision lens in one eye had excellent distance vision, averaging better than 20/20 at 6-month follow-up. Visual acuities at inter- mediate and near were approximately 20/25 and 20/33, respectively, when tested in one eye and allowed patients to read without glasses, the news release said. Visual outcomes are expected to improve when the lenses are implanted bilaterally. No clinical complications or adverse events were reported in the study.
Proceeds of the Series D funding will be used to com- plete patient enrollment in an ongoing CE Mark study of the FluidVision accommodating IOL. Patient enrollment is expected to be completed by the end of the year, and receipt of the CE Mark and the subsequent launch of a US pivotal study are projected for 2015, the news release said.
Avedro Becomes Global Supplier of MedioCross Riboflavin for CXL
Avedro has entered into an exclusive agreement to purchase the MedioCross riboflavin products of Medio- Haus-Medizinprodukte, according to a company news release. Since 2010, Medio-Haus has manufactured Avedro’s proprietary VibeX riboflavin products and will now also provide all of its MedioCross riboflavin prod- ucts exclusively through Avedro. Avedro’s riboflavin products are used with the company’s KXL System for performing LASIK Xtra and accelerated corneal collagen crosslinking (CXL).
The MedioCross riboflavin products are currently used with a variety of crosslinking devices and had previously been supplied to distributors through Peschke-Meditrade. Avedro will continue to offer the full line of Medio-Haus riboflavin products to prevent any interruption of supply to current customers of those products located outside of the United States. In the coming weeks, Avedro will reach out to ophthalmologists who use MedioCross products and the distributors currently selling to them to ensure a continued supply, according to the news release.
Association Seen Between Ocular Comorbidity, Visual Function After Cataract Surgery
Multiple ocular comorbidities, age, preoperative waiting time, and pre- and postoperative distance BCVA affected patient improvement and self-assessed visual function after cataract surgery, according to a study in the Journal of Cataract & Refractive Surgery.1
Magnus Grimfors, MD, of St. Erik Eye Hospital in Sweden, and colleagues conducted a clinic-based cross- sectional study including 41 Swedish cataract surgical units. Patients who had cataract surgery from 2008 to 2011 completed the Catquest-9SF questionnaire preop- eratively and 3 months postoperatively. Questionnaire data were converted into interval data using Rasch analysis, and multiple regression and logistic regression models were used to examine possible predictors asso- ciated with self-assessed visual function after cataract surgery.
“Cataract surgery is performed to improve visual function and [patient] quality of life. However, visual acuity measurement is insufficient to evaluate surgical outcomes and a need exists for other tools to evaluate patients’ self-assessed visual function and the impact of cataract surgery,” the study authors wrote.
The total questionnaire was completed by 10,364 patients. Those without diabetic retinopathy, cornea guttata, glaucoma, macular degeneration, any other comorbidity, or the presence of more than one ocular comorbidity had greater improvement in self-assessed visual function than their counterparts. Patients with other factors such as young age, female sex, short pre- operative surgical waiting time, and low pre- and high postoperative distance BCVA also had significantly greater improvement in self-assessed visual function. Young patients and those with no specific ocular comorbidities, a short surgical waiting time, and low preoperative and high postoperative distance BCVA had significantly higher self-assessed postoperative visual function. Patients without the aforementioned ocular comorbidities and high postoperative distance BCVA had a higher odds ratio of general satisfaction rather than dissatisfaction.
“Our findings might affect clinical practice regarding when to perform surgery and how to inform patients about the surgical benefits,” the study authors concluded.
- Grimfors M, Mollazadegan K, Lundström M, Kugelberg M. Ocular comorbidity and self-assessed visual function after cataract surgery. J Cataract Refract Surg. 2014;40(7):1163-1169.
Pediatric CXL Equally Safe as Adolescent, Adult CXL
Pediatric CXL may be equally safe as adolescent and adult CXL, a study in the Journal of Refractive Surgery suggests.1 Before CXL, cones in pediatric keratoconic cor- neas were located more centrally than those in the two older age groups; after CXL, pediatric corneas showed more corneal flattening and more improvement in dis- tance BCVA, the study authors found.
Nienke Soeters, BOptom, of University Medical Center Utrecht, Netherlands, and colleagues compared the effect of CXL for keratoconus in various age groups and investigated the influence of the topographic cone location on the outcome of CXL. This cohort study included 95 patients (119 eyes) diagnosed as having progressive keratoconus who underwent epithelium-off standard protocol CXL from January 2010 through May 2012. Patients were divided into three age groups: pedi- atric (<18 years), adolescent (18 to 26 years), and adult (>26 years).
The investigators found that topographic cones were located more centrally in pediatric corneas (0.85 ±0.66 mm) compared with adolescent (1.49 ±0.76 mm; P=.002) and adult corneas (1.86 ±0.99 mm; P<.001). Pediatric corneas were flattened 1 year after CXL by a mean 1.80 D, compared with 1.10 D in the other age groups. Central cones (0–1 mm) were steeper (62.30 ±8.30 D) before treatment than peripheral cones (3–4 mm; 55.90 ±8.90 D). One year after CXL, distance BCVA improved in all age groups, with the highest improve- ment in pediatric eyes (-0.23 ±0.40 logMAR; P=.044).
- Soeters N, van der Valk R, Tahzib NG. Corneal cross-linking for treatment of progressive keratoconus in various age groups. J Refract Surg. 2014;30(7):454-460.
–Compiled by Steve Daily, News Editor; and Callan Navitsky, Senior Editor