Does Dr Gunther Grabner from Austria have the answer?
The Visian Implantable Collamer Lens (ICL) was featured prominently in more than 40 presentations by leading ophthalmologists at meetings prior to and during the 2010 Congress of European Society of Cataract and Refractive Surgeons (ESCRS) held in Paris, France. The presentations, based on studies conducted by surgeons throughout the world, indicated that the Visian ICL offers superior visual results over a wide range of myopic and hyperopic refractive errors including those within the most popular LASIK areas of treatment. The company also says the presentations confirmed the safety and efficacy of the Visian ICL over a period of 17 years.
Dr Paul Dougherty from the US presented results showing that the Visian ICL was a very safe and effective treatment for lower myopes. His preference for patients with myopia over 3.0 diopters of refractive error is the Visian ICL. In his practice the Visian ICL visual results (88% of eyes 20/20 or better), accuracy and safety are better than LASIK. Ophthalmologists in international markets that accept CE Mark approval will now be able to treat below 3.0 diopters.
Several presentations reinforced the low complication rate of cataract formation in patients with the Visian ICL. Dr Tobias Neuhann presented the results of the German Study Group, which reflected a 1.4% rate of cataract formation among the 436 patients in the study.
In a study of visual outcomes and the safety of the Visian ICL in Chinese eyes, Dr Xingtao Zhou reported a cataract formation rate of 1.67% in his study of 658 eyes.
Dr Jose F. Alfonso from Spain reported a cataract formation rate of 1.4% in a seven-year study of 734 patients.
These studies compare with an incidence of 1.3% anterior subcapsular cataract formation in STAAR's FDA clinical study with five years follow-up. All eyes with cataract formation were associated with very high myopes, over -12.5 diopters. Only one of those eyes was from a patient younger than 40 years of age. The total study included 526 eyes.
Dr Scott Barnes from Fort Bragg in the US reported that 75% of the soldiers in which he has implanted the Visian ICL see better now than they did with contact lenses before surgery, and none saw worse. In contrast only 10% of soldiers who underwent LASIK reported better results than with contact lenses and 50% responded their vision was worse. The average age reported on was 28 years and over one third of the respondents had a refractive error of -6.0 diopters or less.
Dr Cheryl Lee from Singapore opened an Implantable Lens Centre in January of 2009. Her experience has been that the quality of vision with the Visian ICL is better than vision with glasses, contact lenses or LASIK. Her centre now has patients walk in to ask for the ICL.
In addition, Dr Kenneth Lipstock, an ophthalmologist based in Richmond, Virginia and a member of STAAR's CAST (Collamer Accommodating Study Team), presented on the nanoFLEX IOL, which uses the same Collamer material of the ICL. The nanoFLEX, an intraocular lens used for the treatment of cataracts, has demonstrated in early clinical observations the ability to improve near and intermediate vision. Dr Lipstock was impressed by the results at near and intermediate vision with the nanoFLEX IOL, reporting that nanoFLEX intermediate visual results were equal to or better than competitive products including Crystalens HD and, ReZOOM and ReSTOR. Dr Lipstock also presented retrospective data on patients where he had used nanoFLEX for monovision treatments. His data showed that with less than a 2 diopter offset, on average his patients could achieve 20/20 distance vision and 20/25 near vision. In Dr Lipstock's view, the nanoFLEX IOL is a great option for patients who do not want to spend extra money for presbyopic correction.
On Monday evening, STAAR Surgical sponsored a Symposium on refractive surgery that was attended by over 400 surgeons. In 16 video based presentations, leading global refractive surgeons demonstrated how practitioners can further fine tune success in refractive surgery results.
The newly expanded indications of the Visian ICL for international markets more than doubles the potential market for the ICL, said Barry G. Caldwell, President and CEO of STAAR. The lower diopter range for both myopic and hyperopic patients will now be available in 0.25 diopter increments with new pricing segmentation, which will allow the Visian ICL to compete more effectively with LASIK. The addition of a Visian Toric Hyperopic ICL and the ability to treat mixed astigmatism will also increase the addressable market with the Visian ICL. Results from an interactive response system of the attendees at the ICL Expert's Meeting revealed the belief shared by 40% of the group that within five years, 40% of all refractive procedures would be with phakic IOLs.