At Press Time

A New Wrinkle: EMR by Subscription

Cloud computing makes offsite EMR possible.

By Jerry Helzner, Senior Editor

■ You've probably been hearing the fascinating—but somewhat vague term—“cloud computing” more and more in recent months. Still in its infancy, cloud computing is characterized by centrally located, high-volume servers that allow individual users access to software and information on demand through the Internet. Cloud computing has often been compared to the electricity grid—a shared resource that is always readily available to a large number of customers who pay fees to participate.

The question now being asked by the medical community is whether cloud computing can be used, especially by smaller practices, to more quickly transition to electronic medical records and thereby qualify for federal government bonus payments that are only available to practices that successfully make the transition.

An example of this interest is the recent AAO meeting in October, where David Silverstone, MD, of New Haven, Conn., gave a standing-room only presentation on the potential of cloud computing in healthcare.

“With cloud computing, you purchase a service rather than hardware and software. Most of us currently use cloud computing in the form of smart-phone apps or Web-based email,” Dr. Silverstone says. “Innovative companies such as Athenahealth and MDIntelleSys are now selling Web-based EHRs and practice management systems that are often more powerful and more secure than the more expensive traditional products.”

He is enthusiastic about the future of cloud computing in EHR. “I think it represents a total paradigm shift,” he continues. “Practices will be relieved of the burden, expense and liability of having to locally maintain hardware and software.”

It is too early to provide a truly definitive answer to the future of cloud computing in ophthalmology, but already entrepreneurs are coming up with intriguing ideas that could make cloud computing a reality for practices willing to live with some compromises in exchange for cost savings. For ophthalmology practices, the compromises would currently include trusting patient records to an offsite, third-party system that may have thousands of customers, forsaking such important EMR features as drawing, and even having to view advertising messages each time you access the system.

But if we are giving high marks for ingenuity, a San Francisco company named Practice Fusion has come up with a cloud-based system financed by advertising and that offers medical practices a “free” certified, well-supported EMR service that Practice Fusion says will qualify the practice for bonus payments of up to $44,000. If the practice does not want to be encumbered by having to view ads, an ad-free subscription is available for a monthly fee of $100 per practitioner. Practice Fusion is partnering with Salesforce.com, an emerging powerhouse in the cloud computing sector and the developer of the Force.com cloud computing platform.

Though Practice Fusion is an early entrant, other cloud-based competitors, including GE Healthcare, are sure to follow. The cloud systems may be especially attractive to smaller practices that would like to make the transition to EMR without the burden of a large initial investment for an in-house system and the hiring of an IT specialist.

Femto-phaco Offers New Level of Precision

OptiMedica system is superior to manual incisions in Stanford study.

■ Global ophthalmic device company OptiMedica Corp. said data from a 59-eye study showed that, when compared to manual techniques, the company's Catalys Precision Laser System helped surgeons achieve significant improvement in precision during several critical steps of cataract surgery.

The results were published recently in the peer-reviewed journal Science Translational Medicine.

“These study results clearly indicate that a femtosecond laser with integrated ocular coherence tomography imaging, advanced optics and control software can provide multiple benefits for cataract surgery,” said the study's lead author, Daniel Palanker, PhD, associate professor, Department of Ophthalmology and Hansen Experimental Physics Laboratory, Stanford University. “We believe the new laser-assisted technique represents a significant scientific and clinical advancement that will make cataract surgery much more precise and reproducible.”

OptiMedica, based in Santa Clara, Calif., is one of three companies currently developing femto-phaco systems for cataract surgery. The others are LenSx and LensAR. LenSx, which was recently purchased by Alcon for approximately $361 million, thus far has achieved FDA 510 (k) clearance for performing three major steps of the cataract surgery procedure: capsulotomy, lens fragmentation and corneal incision. LensAR has received FDA clearance for capsulotomy.

Catalys is designed to perform four incisions: capsulotomy, lens fragmentation, relaxing incisions and cataract incisions. Results of the clinical study, which compared 29 laser-treated eyes with 30 manually-treated eyes, showed great improvement across the following steps.

► A 12-fold improvement in precision of sizing the capsulotomy with Catalys as compared to the manual technique, and a five-fold improvement in the precision of the capsulotomy shape. These findings are deemed significant, as capsulotomy shape and size are known to have a critical impact on refractive outcomes.

► A more than two-fold improvement in capsulotomy strength. OptiMedica says this improvement has the potential to make the procedure safer by reducing the potential for lens capsule rupture.

► A 40% reduction in the use of ultrasound energy during phacoemulsification, which has the potential to simplify the process of emulsifying and removing the lens.

“The significant gains in precision we were able to achieve in the clinical study of Catalys represent an incredibly exciting development in the field of cataract surgery,” said the publication's co-author William Culbertson, MD, professor of ophthalmology at Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami. “A more precise procedure will enable cataract surgeons to more accurately position the IOL, and this is key to visual outcomes. Dr. Culbertson is chair of OptiMedica's Medical Advisory Board.

Catalys is not yet for sale in the United States. OptiMedica expects to launch Catalys worldwide in 2011.

Perfectly sized (5.0 mm) and positioned, round anterior capsulotomy (red arrows) with four- quadrant segmentation and softening (0.5 mm cubes) created by a femtosecond laser.

Ista Dry Eye Drug Shows Promise

Phase 2 data encouraging; phase 3 trials begin.

■ Ista Pharmaceuticals said its investigational dry eye therapy Remura (bromfenac ophthalmic solution for dry eye) achieved statistical significance in a phase 2 study in the primary endpoint of the objective sign of conjunctival staining as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining as compared to baseline.

In addition, patients achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) and in patients' most bothersome ocular symptoms. Patients treated with Remura maintained the improvements in the signs and symptoms of dry eye disease for 10 days after discontinuing treatment, which was evaluated at the time of the follow-up visit. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.

The Remura phase 2 study enrolled 38 patients who exhibited signs and symptoms consistent with moderate dry eye disease. The study was designed to investigate the effects of Remura compared to baseline on the objective signs of conjunctival staining (lissamine green test) and corneal staining (fluorescein test), as well as subjective symptoms, including OSDI and patients' most bothersome ocular symptoms), when administered under normal environmental conditions. All patients received Remura in both eyes, twice daily, for 42 days. Patient baseline scores were recorded prior to the first treatment with Remura and were compared to scores at Day 14, Day 42 and Day 52.

Ista recently announced the Company has initiated its Remura phase 3 clinical study program. Two phase 3 studies to evaluate the efficacy and safety of Remura are being conducted under a Special Protocol Assessment (SPA) agreed upon with the FDA and two remaining phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. Ista anticipates starting the remaining safety studies later this year and reporting results for the first two phase 3 efficacy and safety studies in the middle of 2011.

Retina Roundup

Timely and Important Retina News of Interest to All Ophthalmologists

Compiled by Andrew E. Mathis, PhD, Medical Editor

► Promising VEGF Trap-Eye results. Data recently released from the VIEW 1 trial of Regeneron's VEGF Trap-Eye for wet AMD indicate that 2 mg dosing of the drug provides a highly durable response.

The US-based trial, which was paired with an international trial called VIEW 2, found that every two-month dosing of 2 mg of VEGF Trap-Eye led to a mean 7.9-letter gain in visual acuity, compared to 8.1 letters with a monthly 0.5 mg dose of ranibizumab. Furthermore, 95% of the patients receiving 2 mg VEGF Trap-Eye injections every two months maintained their vision gains. Results in the international trial were comparable.

Ocular side effects for VEGF Trap-Eye were mild and included injection-site hemorrhage, eye pain and vitreous floaters.

Patients in the VIEW trials will continue to be treated with the same dosages of VEGF Trap-Eye, but now every three months, unless retreatment is warranted sooner. Based on the results of the two VIEW studies, Regeneron and its partner, Bayer HealthCare, will apply for regulatory approval in both the US and Europe in the first half of 2011.

● Also, In Regeneron's phase 3 COPERNICUS study for CRVO, 56.1% of patients receiving VEGF Trap-Eye 2 mg monthly gained at least 15 letters of vision from baseline, compared to 12.3% of patients receiving sham injections at six months, the primary endpoint of the study.

● Regeneron and Bayer HealthCare also reported 52-week follow-up results from the phase 2 DA VINCI study in patients with DME. In this study, visual acuity gains achieved with VEGF Trap-Eye treatment over 24 weeks were maintained or numerically improved up to completion of the study at week 52 in all VEGF Trap-Eye study groups, including 2 mg of VEGF Trap-Eye dosed every other month.

Mean 52-week VA gains in four Trap-Eye dosing schedules ranged from 9.7 letters to 13.1 letters, while the mean loss in 52-week VA in laser-treated group was 1.3 letters.

► OSA and RVO. On the heels of a study on the ocular effects of obstructive sleep apnea (OSA) that was published in November 2010 by Current Opinion in Ophthalmology comes a more specific report linking OSA to retinal vein occlusions. This study, conducted in Paris, appears in the December 2010 issue of Archives of Ophthalmology.

The study diagnosed OSA in 23 patients out of 30 who had been diagnosed with RVO. These 30 patients were part of a larger cohort of 63 patients. While the study authors caution that the possibility exists that none of the 33 unscreened patients had OSA, nevertheless the OSA rate of 77% among the screened patients was very high.

Though the only statistically significant measurement in the study was between OSA and body mass index, the authors believe OSA may be a contributive risk factor for RVO, or at the very least a triggering factor. They speculate on the possible link between OSA and blurred vision upon awakening in RVO patients and urge screening for OSA in all RVO patients, because of the serious health risks associated with OSA.

► Lucentis without vision loss. Ranibizumab therapy is a proven treatment for wet AMD and has been shown to stabilize and improve lost visual acuity, but how well does it work in patients who have not lost significant visual acuity? The November 2010 issue of the British Journal of Ophthalmology contains a study that seeks to answer that question.

Retinal physicians at hospitals in the United Kingdom studied 14 eyes in 14 patients who had been diagnosed with wet AMD but had maintained visual acuities of 6/12 (20/40 standard measurement) or better. Any patients who had undergone prior treatments with PDT or anti-VEGF agents were excluded from the study.

All but one of the 12 patients maintained their baseline visual acuity or improved at one year. Three of the patients finished the study with perfect vision. Though the authors of the study concede that it is limited due to its small size, they nevertheless conclude that the argument for early treatment with ranibizumab is strengthened by their research, and they urge that the “upper cap” for treatment for wet AMD with the drug be re-evaluated.

► Immunosuppression for AMD. Fueled by discussion that there is a possible immune factor at work in the development of AMD, scientists at the National Eye Institute in Bethesda, Md., undertook a study to determine whether immunosuppressive agents achieved a comparable effect to anti-VEGF agents in treating AMD. They report their results in the November/ December 2010 issue of Retina.

Patients in the study arm were randomized to receive either daclizumab, rapamycin or infliximab for six months, in addition to anti-VEGF therapy if certain criteria were met. The control study received anti-VEGF therapy for the same period of time.

The most significant result of the study was that patients in the daclizumab and sirolimus arms saw a decrease in the number of injections they received from 0.73 to 0.42 per month for daclizumab and from 0.67 to 0.34 per month for sirolimus. There was no decrease in injections for patients receiving infliximab or for patients in the control group. Visual acuity was stable in all four study arms.

As this was a very small trial (13 patients), no firm conclusions can be drawn, but the study provides enough evidence to warrant further studies of the ability of immunosuppressive agents to, at the very least, decrease the number of injections that patients with wet AMD may require. Daclizumab may be the breakout agent among the drugs used here, based on the statistical measures presented. OM