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Volume 17, Number 4
30 January 2012



Ophthalmology groups provide guidance in billing Medicare for femtosecond laser use
The American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS) have developed a guide for billing Medicare and beneficiaries when using the femtosecond (FS) laser. The guidance outlines instances when billing for use of the FS laser is or is not clearly permissible. It is important to note that the guidelines are subject to modification based on new regulations issued by the Centers for Medicare and Medicaid Services or its contractors. These guidelines only apply to the Medicare fee-for-service program. Additional guidance should be sought directly from the carriers for coverage determinations under Medicare Part C or through commercial carriers. The guidelines were developed with input from legal counsel and ophthalmology experts.
For more information, contact Catherine G. Cohen, AAO vice president of governmental affairs, at +1-202-737-6662, or Nancy McCann, ASCRS director of government relations, at +1-703-591-2220.


Stellaris receives Japanese Ministry approval
The Japanese Ministry of Health, Labour and Welfare has approved the Stellaris PC (Procedural Choice) Vision Enhancement System for vitreoretinal surgery as well as cataract surgery, joint marketers Bausch + Lomb Japan (Tokyo, Japan) and Topcon Medical Japan (Tokyo) said in a news release. In Japan, cataract surgery is often performed in conjunction with vitreoretinal surgery. Under the agreement, Bausch + Lomb Japan is responsible for importing product and Topcon Medical Japan is responsible for sales, maintenance, and service. The two companies share responsibility for promotional activities.


Cirrus HD-OCT granted AMD, glaucoma module clearance
The US Food and Drug Administration has granted approval to Carl Zeiss Meditec (Dublin, Calif., USA) for its dry age-related macular degeneration (AMD) and glaucoma diagnostic tools for Cirrus HD-OCT.
The new Cirrus HD-OCT retina application provides Advanced Retinal Pigment Epithelium (RPE) Analysis, which enables clinicians to objectively monitor changes associated with dry AMD, the company said. The application tracks changes in RPE elevation area and volume often associated with drusen. It also identifies and measures the area of transparent regions in the RPE that can develop with geographic atrophy.
The newly approved package adds Ganglion Cell Analysis and Optic Nerve Head Progression Analysis. The Ganglion Cell Analysis evaluates the thickness of the combined ganglion cell and inner plexiform layers and compares the results to normative data. The software received a CE mark in Europe in November.


NovaBay launches phase Iib adenoviral conjunctivitis study
NovaBay Pharmaceuticals (Emeryville, Calif., USA) solidified plans for a global study of up to 450 patients with confirmed adenoviral conjunctivitis at investigational sites in India, Brazil, and the United States, the company said in a news item. NovaBay's phase Iib clinical trial of NVC-422 for the treatment of adenoviral conjunctivitis is expected to begin enrolling patients in the second quarter of 2012.


Integrin peptide shows promise in phase I study
More than 50% of patients in a phase I study for the treatment of diabetic macular edema experienced 3-5 lines of improvement in best-corrected visual acuity when dosed with integrin peptide therapy (Allegro Ophthalmics, San Juan Capistrano, Calif., USA), the company said in a news item. Those same patients also exhibited improvements in optical coherence tomography central macular thickness.
The open label, single-dose study focused on determining the safety and initial efficacy of ALG-1001, an anti-integrin oligopeptide. All enrolled subjects had advanced stage DME with or without early proliferative diabetic retinopathy and had an acuity no better than 20/100 (6/30). Treatment benefits lasted through the study period of 90 days, the company added. Integrin peptide therapy works by delivering a small, anti-integrin oligopeptide that shuts off vascular endothelial growth factor at its source, the company said.


RPB grants a total of US$130K to two institutions
Research to Prevent Blindness (RPB, Chicago, Ill., USA) has granted US$100,000 to the University of Louisville (Kentucky, USA) to "support research into the causes, treatment, and prevention of blinding eye diseases", the University said. RPB further awarded Massachusetts Eye and Ear, a teaching affiliate of Harvard Medical School (Boston, Mass., USA), a US$30,000 Medical Student Eye Research Fellowship, the group said. The Mass Eye fellowship will fund the development of an algorithm to objectively evaluate anatomical changes in the eye believed to be associated with certain types of eye drops used to treat glaucoma.


LSU to make 'drastic' cuts to programs
According to local newspaper reports, the Louisiana State University Health System's University Medical Center (Baton Rouge, La., USA) needs to make "drastic cuts" to its programs because of state budget cuts. Among the services being cut are pediatrics, labor and delivery services, neonatal intensive care units, ophthalmology, ENT services, and an orthopedic clinic, The Advertiser.com said. The website added that about 90 employees and another 17 physicians would be affected.


Elsevier to publish The Ocular Surface
Elsevier (New York, NY, USA) will now publish The Ocular Surface, a peer-reviewed journal about the external eye and vision, the publisher said. The journal's "critical review articles cover the most current knowledge on medical and surgical management of ocular surface pathology, new understandings of ocular surface physiology, the meaning of recent discoveries on how the ocular surface responds to injury and disease, and updates on drug and device development", Elsevier said.


RESEARCH BRIEFS
  • Combining the clinical and questionnaire data can allow clinicians to rank patients on a single linear scale, according to Colm McAlinden, PhD, and colleagues in both Australia and Sweden. The approach modifies the ranking that occurs with the FIFO model and could be used for prioritizing patients for surgical intervention, the group suggested. More sophisticated models incorporating more clinical information may provide a better measure of the cataract impact latent trait, they added. In their prospective study, 293 pre-op cataract surgery patients (mean age: 72.8±10 years; age range: 33-98 years; 174 female, 119 male; 49% with comorbidity) completed two questionnaires and visual acuity was measured in each eye. A cataract impact model was created and was found to be unidimensional, with adequate precision and the components well targeted to the population. Two hundred and twenty-seven (77.5%) patients moved by at least 49 rank positions. The study is published in Investigative Ophthalmology & Visual Science.
  • Dry eye disease is a multifactorial disorder of the tears and ocular surface characterized by symptoms of dryness and irritation, according to an overview of the topic in Archives of Ophthalmology. William Stevenson, MD, and colleagues assert that while the pathogenesis of dry eye disease is not fully understood, it is recognized that inflammation has a prominent role in the development and propagation of this debilitating condition. Factors that adversely affect tear film stability and osmolarity can induce ocular surface damage and initiate an inflammatory cascade that generates innate and adaptive immune responses. These immunoinflammatory responses lead to further ocular surface damage and the development of a self-perpetuating inflammatory cycle. Researchers reviewed the fundamental links between inflammation and dry eye disease and discussed the clinical implications of inflammation in disease management.
  • The use of 3% diclofenac gel may be a useful therapeutic option when used alone in patients with localized disease or to reduce the size of larger, more diffuse lesions before cryotherapy in patients with periocular actinic keratosis, according to Ruchika Batra, MRCOphth, and colleagues. The group evaluated four consecutive patients with periocular actinic keratosis who were treated with topical 3% diclofenac gel twice daily for up to 4 months. Patients were reviewed at 1 and 2 months and then as clinically required up to 13 months after treatment. All four patients had biopsy-proven actinic keratosis. Three patients tolerated the therapy. In the remaining patient, erythema, crusting, and scaling occurred after 2 months of therapy, which resolved within a month of discontinuing topical diclofenac. In all the patients, a visible decrease in lesion severity was seen after 1 month and complete resolution within 4 months. Recurrences occurred in two patients at 4 and 7 months after treatment. These were successfully managed, in one patient, by excision, and in the other, with further 3% diclofenac gel followed by cryotherapy. The study is published in Ophthalmic Plastic & Reconstructive Surgery.


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