Quick Hits

Five-year results similar for two leading shunts

Ahmed and Baerveldt go head to head.

The first five-year results of a trial comparing the effectiveness and safety of the two most common glaucoma shunts, the Ahmed FP7 (New World Medical, Rancho Cucamonga, Calif.) and Baerveldt 350 (Abbott Medical Optics, Abbott Park, Ill.), found similar rates of outcomes, complications and failure, although the nature of those results varied.

Donald Budenz, MD, MPH, of the University of North Carolina, Chapel Hill, presented early five-year results of the Ahmed-Baerveldt Comparison Study (ABC) at the American Glaucoma Society annual meeting in Washington, DC. Recent AGS data shows 42% of respondents use the Ahmed shunt and 52% the Baerveldt device.

“These two implants have radically different designs and individual surgeons were very, very passionate about one or the other,” Dr. Budenz said.

In the study, 143 patients received the Ahmed valve and 133 the Baerveldt device. Clinical and demographic characteristics were similar between the two groups. At five years, both groups had similar failure rates of approximately 40%, but for varying reasons.

Different types of failures

“The Ahmed implants tended to fail more commonly due to IOP being too high, either repeating measurements of IOP over 21 mm Hg or requiring reoperation for IOP,” Dr. Budenz said. “In the Baerveldt group, more patients failed due to safety concerns; these included complications necessitating removal of the implant, such as vision of no light perception, or hypotony.” NLP vision mostly occurred in the setting of neovascular glaucoma, he noted.

The Baerveldt device achieved lower IOP, Dr. Budenz reported. “With final IOP measures in the Ahmed group of 14.8 mm Hg on average and 12.7 mm Hg on average in the Baerveldt group, that was highly statistically significant in favor of lower IOP in the Baerveldt group,” he said.

With regard to complication rates, Dr. Budenz said, “There were more tube occlusions in the immediate postoperative period in the Baerveldt group, a phenomenon that we cannot explain.” However, the sample size was too small to derive any definitive conclusion.

Neovascular glaucoma may be one determinant to dictate the selection of one shunt over the other. “A subgroup analysis for reasons of complete loss of vision suggested patients with neovascular glaucoma might be better off with the Ahmed FP7,” Dr. Budenz said, acknowledging the sample size, again, was quite small.

“Continue to use what you are comfortable with, but expect higher long-term IOPs and increased need for reoperation with the Ahmed FP7, which is a smaller implant, and expect more serious complications with the Baerveldt 350 implant,” Dr. Budenz told the audience.

STAAR toric ICL gets favorable FDA advisory panel vote

Phakic lens takes a step toward approval. Many patients have been on waiting lists.

By Bill Kekevian, Senior Associate Editor

Recent FDA advisory panel action may be the light at the end of the tunnel for STAAR Surgical, whose phakic Visian TICL (for toric implantable contact lens) has been in the works for almost a decade. The agency’s Ophthalmic Device Panel, which reviews and evaluates data concerning devices for use in the eye, recently voted favorably on three questions posed by the FDA’s Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices. The questions related to the TICL and whether the lens was safe and effective for the proposed indications.

The original TICL submission to the FDA was filed in May 2006, shortly after the original ICL for myopes was approved in December 2005, according to Robert Rivera, MD, director of clinical research at Hoopes Vision in Draper, Utah. “While we have been awaiting formal FDA approval of the TICL, internationally it has gained widespread adoption in more than 60 countries, with 140,000 lenses having been implanted,” he says.

What the TICL can do

The Visian TICL is a refractive phakic implant placed in the posterior chamber between the iris and the natural crystalline lens. Its design would give surgeons the ability to correct both myopia and astigmatism in a single procedure. Currently, no phakic IOL is approved for astigmatism correction in the United States, but the waiting list has grown, Dr. Rivera says.

“Most practices that have been performing myopic ICL surgery in the United States have been keeping a list of patients who would be best served with the toric version of the lens. Some lists go well into the 700-800 range, which speaks to the extent of the unmet need for such an implant,” he says.

The Visian TICL has a foldable design and features collamer, a material with a low refractive index of 1.44 (compared with 1.41 for silicone and 1.55 for acrylic).

Dr. Rivera says the advisory panel vote brings ophthalmologists a step closer to improving patient care. “The ability to correct a patient with myopia who also happens to have significant astigmatism is absolutely unparalleled with the toric ICL,” he says. “Further, there are so many patients who would never be candidates for refractive surgery due to keratoconus, corneal scars and a number of other conditions, who will be excellent toric ICL candidates.”

Congress delays ICD-10; passes another SGR ‘fix’

AAO decries last-minute action.

In a last-minute flurry of activity just before the March 31 deadline for action, Congress passed legislation that will delay the implementation of the ICD-10 codes for one year while also creating another short-term “doc fix.” The doc fix, which drew sharp criticism from physicians’ groups, again postpones meaningful action on ending the flawed sustainable growth rate (SGR) formula for determining Medicare reimbursement.

“Congress has punted for the 17th time, opting to pass a temporary solution to the extreme Medicare physician pay cut caused by the faulty sustainable growth rate formula,” said David W. Parke II, MD, CEO of the American Academy of Ophthalmology.

Some physician advocate groups welcomed the delay in ICD-10 implementation until October 1, 2015, saying that physicians, payers and software vendors all needed more time to prepare for dealing with the new codes. However, other constituencies, including organizations representing hospital administrators, said intense preparation for the advent of the ICD-10 codes is already well under way and a delay now would be counterproductive and cause a loss in momentum.

The doc fix extends the three-month 0.5% Medicare payment increase that went into effect January 1 until the end of 2014.

Avedro crosslinking faces approval delay

Avedro Inc. (Waltham, Mass.) said it received a complete response letter from the FDA regarding the New Drug Application (NDA) for its riboflavin ophthalmic solution/KXL System for corneal collagen crosslinking. In the complete response letter the agency identified a number of areas of the application that require additional information.

“We plan on working closely with the FDA to resolve these issues as quickly as possible to make this important treatment available to patients in the United States,” said David Muller, PhD, CEO of Avedro. “While we do not yet have an estimate on how long it will take to resolve the issues, we are confident that we can adequately answer their questions.”

Avedro based its NDA on a 512-patient multicenter US trial that treated patients with keratoconus or corneal ectasia. Crosslinking is used routinely in Europe.

New Online Instrument Directory

PentaVision LLC, publisher of Ophthalmology Management and Retinal Physician magazines, in partnership with MediaBrains, has created a new online directory of comprehensive listings of ophthalmic equipment vendors, crossreferenced by 20 different equipment categories. The “Ophthalmic Diagnostic Instrument Directory” serves as a resource for practices seeking to purchase ophthalmic equipment.

Readers can quickly access a wide range of detail on ophthalmic equipment at www.ophthalmicequipmentdirectory.com.

AAO launches IRIS registry to collect data

The American Academy of Ophthalmology has formally launched its IRIS (Intelligent Research in Sight) registry, the nation’s first comprehensive eye disease and condition registry. The centralized data repository and reporting tool aggregates patient data from electronic health records and performs statistical analyses that enable ophthalmologists to improve patient care, reduce the cost and enhance the speed of some large clinical trials, assist in monitoring resource utilization, comply with federal payment programs and enhance quality and practice efficiency.

IRIS is the nation’s only comprehensive, longitudinal, outpatient-focused clinical data registry for ophthalmology. Physicians and eye surgeons who share data using the IRIS registry can access the growing body of knowledge it houses as they measure their own performance against benchmarks.

Already, 2,300 physicians in 47 states are participating in the IRIS registry, according to the AAO. The registry currently holds more than 5 million patient records and is expected to house more than 20 million in two years.

“This is a watershed moment for the field of ophthalmology,” said David W. Parke II, MD, CEO of the Academy. “We as physicians find ourselves able to harness the power of many millions of pieces of clinical information in order to make evidence-based decisions in a fraction of the time it would have taken 10 years ago. The IRIS Registry is truly a revolutionary tool that will help us improve care for patients and ensure the best possible outcomes.”

OTX sustained-release plug enters phase 3 trial

For pain and inflammation following cataract surgery.

Ocular Therapeutix Inc. (Bedford, Mass.) has begun its phase 3 clinical program to evaluate the safety and efficacy of its sustained release dexamethasone, an ophthalmic corticosteroid for the treatment of inflammation and pain following cataract surgery.

Sustained-release dexamethasone will be administered as a one-time, bioabsorbable intracanalicular plug for release of the steroid to the ocular surface for up 30 days. In the first of two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled studies, 240 patients undergoing clear corneal cataract surgery will be enrolled at sites throughout the United States. Following surgery, patients will be randomized to either the dexamethasone treatment group or a placebo vehicle plug. Primary endpoints are absence of anterior chamber cells at day 14 and reduction of pain at day eight.

“The dexamethasone plug is easily inserted in the operating room immediately following cataract surgery,” stated Thomas Walters, MD, of Texan Eye in Austin, Texas. “In the earlier phase 2 clinical trial, it proved effective for relieving pain and inflammation, and patients were comfortable with use of the plug.”

Physicians routinely prescribe topical steroids postoperatively for the treatment of ocular inflammation and pain. However, patients do not reliably self-administer these drops, which could lead to greater or more persistent inflammation and subsequently affect visual outcomes. Conversely, chronic use of topical steroids can lead to elevations in intraocular pressure, which is a risk factor for glaucoma.

“A single-dose corticosteroid can help manage issues of compliance by putting dosing into the hands of the physician and avoiding up to four drops per day and a tapering regimen which is confusing for the patient,” stated Amar Sawhney, PhD, president and CEO of Ocular Therapeutix.

6 questions to ask your EHR vendor about ICD-10

tip of the month

With ICD-10 due to take effect in October, many practices are scrambling to make sure their practice management and EHR systems are up to the task.

Michael Sherling, MD, MBA, a dermatologist and co-founder and chief medical office of Modernizing Medicine, a EHR provider, suggests physicians put these questions to their EHR vendors to asses their readiness for ICD-10:

1. What is your solution for ICD-10?

2. When will your ICD-10 functionality be available?

3. Are you using look-up tables or mapping solutions for ICD-10, or will your system provide the correct ICD-10 code from your exam notes directly?

4. How much longer will it take me to code a superbill with ICD-10 than with ICD-9?

5. How many added steps will there be to select the correct code?

6. How do you prevent invalid or clinically inaccurate codes?