The FDA granted marketing approval to VISX for the CustomVue™ Laser Vision Correction Procedure. The customised ablation system is now approved for correction of up to –6D of myopia and up to 3 D of cylinder, with a maximum spherical equivalent of -6D. The CustomVue procedure includes the use of the VISX WaveScan™ system and the VISX Star 4 excimer laser. "The results from CustomVue procedures are very impressive, with potential for sharper vision and improved night vision over contacts and glasses. There is no question that this technology is a significant step forward in the advancement of laser vision correction," said Robert Maloney MD, Director of the Maloney Vision Institute and Associate Clinical Professor of Ophthalmology, UCLA School of Medicine, a participant in the VISX multi-center clinical study that led to the approval. VISX is the second company to receive FDA approval for customised ablation. Alcon was the first, receiving an approval for the LADARVision® system in November of last year. Shareholders of the company also recently failed to support an effort by sometime corporate raider Carl Icahn to change the makeup of the board. The shareholders elected all seven candidates nominated by the company and rejected the candidate backed by Carl Icahn. Panel backs CrystaLens The FDA Ophthalmic Devices Advisory Panel gave a favourable ruling to C&C Vision’s CrystaLens™ accommodative IOL application for marketing approval. The panel attached a number of conditions to its recommendation relating to the labeling of the device. The panel expressed concern about insufficient long-term information about the implant and also suggested that patients with large pupils might not be suitable candidates for the device. The CrystaLens is a multi-piece silicone posterior IOL that includes a unique hinge design to allow accommodation. B&L to market brimonidine 0.2% Bausch & Lomb reported that is had received U.S. marketing approval for the glaucoma medication brimonidine 0.2%. Brimonidine 0.2% was sold originally by Allergan under the brand name Alphagan®. That company took the product off the market when it launched Alphagan® P, a lower dose version of brimonidine. The generic form will be available immediately. After losing a legal battle aimed at stopping B&L from marketing the generic form of the drug, Allergan said it plans to introduce a generic form of brimonidine 0.2% AMO adds to Sovereign system Advanced Medical Optics (AMO) launched a new compact element to its Sovereign® line of phacoemulsification instruments. According to the company, the new Sovereign Compact system delivers chamber stability through digital fluidics and a programmable occlusion mode. The phaco system offers a wide range of phaco including the Whitestar™technology for ‘cold’ phaco. Talia RTA goes modular Talia Technology announced that its RTA systems for screening glaucoma and other retinal diseases will be offered as a modular platform. The current RTA platform includes options for retinal thickness mapping, disc topography, RNFL measurement, cross-section views and digital record keeping. Recent enhancements include a nonmydriatic disc topography scanning mode and color-coded slits. The first optional module is a Digital Fundus Imaging system that produces high resolution (1.2 million pixels), wide-angle (covering a 70 x 60 degrees field) red free or color images, and a method for stitching of up to 11 images. Bandage lens for night and day Ciba Vision’s Focus Night & Day contact lenses received approval from the FDA for therapeutic use. The approval allows the lenses to be used as bandage contact lenses and for related therapeutic indications including dry eye and corneal erosion. Russian mobile ophthalmic surgery unit brings relief to dispersed elderly population Ana Hidalgo-Simón MD, PhD ORDINARILY, it makes more economic sense to bring the patient to the surgeon rather than taking the surgeon to the patient’s bedside. But how do you deal with the needs of an elderly, vision-impaired population spread over a large territory? This was the problem faced by Svetlana Y Anisimova, MD and her team at the East-Sight Recover Eye Centre in Moscow, Russia. The solution: a mobile ophthalmic surgery unit equipped to perform a full array of diagnostic and therapeutic procedures. "Many elderly patients face great difficulties visiting doctors because of the lack of travel infrastructure. If they live away from the centre, where most of the clinics are, the expense of travelling and the lack of help in moving becomes a serious problem," Dr Anisimova told EuroTimes. Russia has been a pioneer in taking mobile ophthalmological services to its vast territories and beyond. Over the years, planes, trains, boats and buses have all been utilised to deliver essential ophthalmic surgery services. Although successful in their own right, these initiatives had a high monetary cost and were constrained to relatively large cities of over 500,000 inhabitants. In 1998, a new scheme was introduced - a mobile ophthalmic surgical unit designed and equipped to travel to patients’ houses. Facilities on the moderate-sized vehicle includes an operating table with a microscope with X-Y and zoom systems, lateral and coaxial lighting, a vascular coagulator, A-scan ultrasound and a set of microsurgical instruments. The human element consists of a pool of two or three surgeons, a nurse, an anaesthesiologist, an engineer and a driver. Since its launch in 1998, both the unit and the operating procedures have been refined and a successful routine established. After a room is selected to serve as the operating theatre, it is first sterilised by ultraviolet radiation for 10 minutes. A period of six minutes of irradiation provides 99.9% bactericidal effect for a volume of 100 cubic metres of air, she noted. The operating area is then covered by a set of sterile disposable linens. The surgical field is sterilised and the eye cavity is also washed with kanamycin solution. Anaesthesia is provided by epibulbar anaesthesia. Sedative medications are used very rarely and are only given orally. Some 95% of patients report that their operations are devoid of pain or discomfort, she said. Before commencing the operation, the surgeon instils the conjunctival cavity with 0.5% Tetracain solution for 10 or 15 minutes. Mydriacil, Neosinephrine and Trusopt solutions are also used before tunnel cataract extraction or combined interventions. The Russian mobile service had its debut in the greater Moscow area. The diagnostic team visited bed-bound patients and the surgical team followed when required. The second phase took the mobile unit to various regions of Russia. The van visited 13 towns during 24 individual expeditions. The unit typically stays in a town for three days, of which one-and-a-half days are used for surgery. Local ophthalmologists provide the follow-up. From July 1998 to December 2001 the mobile team examined 2,852 patients, and operated on 509 eyes. Patients ranged in age from 34 to 103 years. The most common operation was cataract extraction using extracapsular with phaco techniques and IOL implantation. The majority of the cataracts operated were mature (72%). The IOP levels of patients operated for glaucoma were 27mmHg or less in 27 eyes, between 28mmHg and 30mmHg in 56 eyes and over 31mmHg in 29 eyes. Patients with mature or nearly mature cataracts and intraocular pressures up to 30mmHg underwent combined surgery consisting of non-penetrating deep sclerectomy plus tunnel cataract extraction and IOL implantation. Routine postoperative care included subconjunctival injection of 0.3ml of dexamethasone and 0.3ml of Gentamicin. Patients all received Garasone (or Maxitrol) and Naclof (or Indocolir) drops and Mydrum or Mydriacil depending on clinical needs. Dr Anisimova reported that there were no intraoperative complications in this series. Follow-up ranging from three months to three years showed four cases of lens subluxation, six cases of transient corneal oedema, eight cases of transitory IOP rise (subsequently eliminated by one instillation of Trusopt or Xalatan), nine cases of iridocyclitis (which required additional treatment with dexamethasone injections) and two cases of postoperative hyphaema. She attributed the success of the programme to recent advances in preoperative diagnosis and operative and postoperative evaluation. New methods of achieving satisfactory anaesthesia and sedation, less invasive operations and the reduction of intraoperative and postoperative complications allow conversion to outpatient surgery in many cases. ‘Custom packs’ for specific operations and the new sterilisation and disinfections procedures also play a key role. Among the advantages of this mobile unit approach are the minimal physical and emotional disturbances to the patient. The fact that those patients are generally elderly and have severe movement restriction makes a trip to a hospital an extremely stressful experience. "Practically all patients operated for cataracts showed some visual improvement. In some cases, accompanying retinal pathology made the improvement modest, but even in those cases many patients regained the ability to look after themselves," Dr Anisimova commented.