At Press Time

Intraoperative OCT proves its value; Study: Femto-phaco safe and effective; Federal regulations: Too much, too soon?; and more

At Press Time

Intraoperative OCT Proves Its Value

Visualization improved in DMEK, DALK and PK.

By René Luthe, Senior Associate Editor

■ Two studies presented at this year's ARVO meeting show intraoperative OCT can help the surgeon with crucial visualization in various types of keratoplasty procedures. In the first, German researchers used the iOCT device (OptoMedical Technologies GmbH) in nine consecutive patients with corneal endothelial dysfunction undergoing Descemet's membrane endothelial keratoplasty (DMEK). The procedure requires precise handling and orientation of delicate graft tissue within the anterior chamber in order to avoid peri- or postoperative graft dislocation. Sufficiently careful unrolling of the thin tissue has proved difficult for surgeons.

Intraoperative OCT was used to visualize the graft within the anterior chamber during orientation and attachment to the posterior cornea. The researchers' evaluation parameters included visualization of Descemet's membrane rolling behavior immediately after preparation, Descemet's membrane rolling inside the eye, and attachment to posterior stroma after insertion and air insufflation.

In all patients, the researchers reported, Descemet's membrane was readily visible within the anterior chamber, thus providing precise visualization of membrane unfolding and correct orientation. Additionally, visualization of the graft by iOCT aided the surgeon in verifying complete graft attachment at the end of the procedure and reduced complete air filling time.

In the second study, the same team of researchers evaluated the use of iOCT to support lamellar preparation in deep anterior lamellar keratoplasty (DALK) and graft alignment in both DALK and penetrating keratoplasty (PK). Optimal graft alignment is necessary in both procedures to ensure good visual outcomes. One patient undergoing DALK and six undergoing PK were included in the study. Evaluation parameters were iOCT visualization of trephination depth, needle location, big-bubble effect, thickness of remaining stromal tissue in DALK and graft alignment, and surface steps in both DALK and PK.

Visualization with iOCT was successful for these measures. In DALK, for instance, trephination depth was visualized and the injection needle could be located in the designated tissue plane. Big-bubble formation was visualized followed by preparation of the posterior lamellar graft; additionally, thickness of remaining stromal tissue was visualized and measured. Graft alignment was visualized too, in both DALK and PK, and interface steps were avoided. Visualization of the interface shape helps the surgeon avoid tissue steps; in the case of DALK, it also helps the surgeon to complete attachment of the donor lamellar.

“Using intraoperative OCT during corneal surgery — in particular in lamellar transplantations — preparation, visualization and handling of the graft and recipient tissue becomes easier by online visualization of cross-sections at high resolution,” lead researcher Philipp Steven, MD, told Ophthalmology Management. “In our opinion, iOCT will become an inevitable tool for performing corneal procedures such as DMEK, DSAEK or DALK and other techniques that require precise navigation within the cornea or the anterior chamber.”

Study: Femto-phaco Safe and Effective

Two easily corrected complications in 115 eyes.

■ A large study undertaken by researchers from the Department of Ophthalmology at New York University and presented at the recent ARVO meeting shows that femtosecond laser-assisted cataract surgery using the LenSx technology (Alcon) is safe and produces excellent visual results.

The study included 115 eyes of 78 consecutive patients who underwent femtosecond laser-assisted clear cornea cataract surgery and who were evaluated preoperatively and six months postoperatively. These patients were evaluated for age, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, cylinder, capsulorhexis diameter, topographic cylinder change, endothelial cell count and complications.

The mean age in this population was 68. Average preoperative UCVA and BCVA was 20/100 and 20/40 respectively, while at six months post-surgery, UCVA was 20/25 and BCVA was 20/22. Spherical equivalent refraction was reduced from 3.7 D to 0.5 D. Cylinder correction improved from -2.25D preoperatively to -0.55 D post-surgery. Average capsulorhexis diameter was 5.8 mm and topographic cylinder changed by -0.45 D. Endothelial cell count pre-surgery was 1850, dropping to 1650 at the sixmonth postoperative evaluation. There were two incomplete capsulorhexes that were completed manually without incident. No other complications were encountered in this group.

The study's lead researchers concluded that femtosecond laser-assisted clear cornea cataract surgery appears to be safe and effective in facilitating emmetropia.

Federal Regulations: Too Much, Too Soon?

AMA wants new deadlines; practices overwhelmed.

■ The American Medical Association and state and national medical specialty societies sent a letter to CMS expressing serious concern about a coming onslaught of overlapping regulations that affect physicians. Programs with overlapping timelines include the value-based modifier, penalties under the electronic prescribing (e-prescribing) program, the physician quality reporting system (PQRS) and the electronic health record incentive program, along with the transition to ICD-10.

CMS has recently responded to some of the concerns about upcoming onerous regulatory deadlines by extending the timeline for implementation of the ICD-10 codes from October 2013 to an indefinite date to be determined. CMS also extended the Stage 2 “meaningful use” of EHR deadline until 2014 for some electronic records adopters who met Stage 1 requirements by the end of last year. However, medical practices may still be unable to comply with the plethora of rapidly changing regulations.

“Facing all of these deadlines at once is overwhelming to physicians, whose top priority is patients,” said AMA President-elect Jeremy Lazarus, MD. “We have asked CMS to develop solutions for implementing these regulations in a way that reduces the burden on physicians and allows them to keep their focus where it should be — caring for patients.”

Without changes from CMS, physicians will be transitioning to the ICD-10 coding system, spending significant time and resources implementing EHRs into their practices, working to successfully participate in the Medicare e-prescribing program, meeting EHR meaningful use standards and participating in the Physician Quality Reporting System — all within a short amount of time.

“In addition to these upcoming deadlines, physicians who treat Medicare patients are also currently facing a drastic cut of about 30% on January 1 from the broken Medicare physician payment formula,” Dr. Lazarus said, triggered by the SGR rule if left unaddressed. “The combination of these financial burdens could prevent physicians from making the investments needed to transition to new models of care delivery and improve the value and quality of care in the Medicare system.”

In the News …
Senators question ASC-to-HOPD conversions. Thirteen US Senators sent a letter to CMS on April 4 requesting an explanation for the 41% percent reimbursement advantage given to hospital outpatient departments (HOPD) over ASCs for the same routine outpatient procedures. The letter questioned whether hospitals were purchasing and converting ASCs to HOPDs for financial reasons.
Ophthalmology Management broke this story nationally by focusing on the topic of ASC-to-HOPD conversions in our March cover story, specifically citing the purchase in 2011 of a large New England ASC by Hartford Hospital and the conversion of that facility to HOPD status.
Accutome purchased by UK company. Halma PLC, a health and safety company based in the UK, has purchased Accutome of Malvern, Pa., for an initial payment of $20 million and potential payments of up to $5 million more based on future earnings results.
Accutome is best known for it broad line of diamond and metal surgical knives and its widely used diagnostic equipment. It also offers pharmaceuticals for ophthalmic use. Accutome management will remain in place and continue to operate the business, said Halma.
CMS clarifies same-day surgery rules. The CMS rule that required ASCs to provide notice to patients of their rights at least one day prior to surgery has been reversed. The agency recently released a letter clarifying the new regulations.
Under the new rules, the ASC is no longer required to provide notice of patient rights in advance of the date of the procedure. Provision of notice on the same day as, but prior to the start of, the surgical procedure is acceptable.
The ASC must provide notice of patient rights to the patient, the patient's representative or the patient's surrogate. The prior rule made no mention of a surrogate. The ASC must also disclose, in writing, physician financial interest or ownership in the ASC, and, where applicable, provide a list of physicians who have financial interest or ownership in the ASC facility.
Avedro participates in new crosslinking study. Avedro has teamed with ACOS (The American-European Congress of Ophthalmic Surgery) to initiate a phase 3, multi-center, randomized, controlled evaluation to study accelerated corneal collagen crosslinking in eyes with keratoconus or corneal ectasia after refractive surgery. ACOS is sponsoring the study, which will be conducted in 100 clinical centers across the United States. Each of the 100 clinical sites will use Avedro's KXL System and VibeX to treat all patients enrolled in the study.
Oral steroids for CME. Brazilian researchers, presenting at the recent ARVO meeting, reported success with oral prednisolone in treating cataract surgery patients who developed cystoid macular edema that was unresponsive to standard-of-care treatment.
The study involved 13 eyes with confirmed idiopathic CME (Irvine-Gass Syndrome) of at least three months duration and that had previously failed a conventional treatment approach with steroidal/non-steroidal anti-inflammatory drops in combination with systemic diuretic agents and VEGF-inhibitors or triamcinolone intravitreal injections.
The researchers reported that the patients received a total oral dose of 1 mg/kg of prednisolone for 45 days. Before treatment, and at two weeks, months 1, 2, 3 and 6 and after treatment, all patients underwent standardized color fundus photography, fluorescein angiography, OCT and ophthalmic examinations, together with standardized assessments of BCVA. Analysis was performed by Freidman test, Kruskal-Wallis test, and Mann-Whitney test.
At month 6, mean BCVA improved from baseline by 10.3 letters. A gain of at least 10 letters BCVA from baseline occurred in 60.8% of the eyes. A significant reduction in central macular thickness as measured by OCT was also achieved. There were no ocular adverse events and no serious collateral effects.
The researchers concluded that systemic steroid therapy emerges as a promising new treatment tool for patients with persistent CME resulting from Irvine-Gass syndrome.
Two-year CATT study data. New data from the CATT study on treatments for the wet form of AMD concluded that Lucentis and Avastin had similar effects on visual acuity over a two-year period.
Researchers found that mean gains in VA at two years were within 1.4 letters and the differences in vision over two years averaged 0.7 letters.
As-needed treatment resulted in VA gains less than monthly treatment. This difference was shown whether as-needed treatment was at enrollment or after a year of monthly treatment. Switching to as-needed dosing after one year of monthly treatment, with either drug, produced a mean 2.2-letter decrease.
In a paper in Ophthalmology, the researchers noted that, over two years, “the rates of death, myocardial infarction and stroke did not differ” between the two drugs. The higher rate of serious adverse events for bevacizumab-treated patients reported in year one continued in year two. Also, as reported for year one, the risk of serious adverse events was not higher with monthly treatment relative to as-needed treatment. Among all organ systems, the greatest imbalance in adverse events was in gastrointestinal disorders. Although the number of these events was small, the researchers noted that this has been an area of concern in previous studies of systemically administered bevacizumab. When all known VEGF-related events were excluded, most of the imbalance remained, leaving it uncertain whether the higher rate of gastrointestinal adverse events reported with bevacizumab was the result of chance, imbalances at baseline not captured in multivariate modeling, or truly higher risk.
The researchers commented that results from clinical trials worldwide may provide additional, independent information about comparative risk between the two drugs.
The CATT research group noted that “in 2010, ranibizumab accounted for nearly 10% of the Medicare Part B drug budget, its single largest expenditure. As treatment of patients continues indefinitely, the cumulative financial burden will only increase. The choice of drug and dosing regimen must balance the comparable effects on vision, the possibility of true differences in adverse events, and the 40-fold difference in cost per dose.”
ASCRS admitting some ODs. At its recent annual meeting, ASCRS established a new membership category that will enable certain optometrists to apply for membership to the organization for the first time. To be eligible for the membership, optometrists must be employed by an ASCRS member, board-certified ophthalmologist.
The new membership category, which emphasizes a working partnership between ophthalmologists and optometrists, supports an integrated model for the delivery of efficient, high-quality healthcare to the 77 million American Baby Boomers rapidly approaching retirement age. The model, endorsed by the ASCRS Executive Committee and Governing Board, encourages arrangements in which employed optometrists, directed and overseen by ophthalmologists, provide a critical role in the delivery of non-surgical eye care.
“We are facing an impending crisis in our ability to deliver adequate eye care with our present delivery model,” said Edward J. Holland, MD, outgoing ASCRS president. “We will simply not have enough ophthalmologists to perform all eyecare needs that will be required, both medical and surgical. One solution to this pending crisis is to become more efficient at what we do. An ophthalmologist-led model will allow a gradual transition of non-surgical eye care to optometry in order to support a more efficient ophthalmic surgeon.”
Ziemer gets femto laser approval. Ziemer Ophthalmic Systems AG said the FDA has granted clearance for the new femtosecond platform, the Femto LDV Z Models. Ziemer says the Femto LDV Z2, Z4 and Z6 are powerful platforms for performing a broad variety of procedures in ocular surgery. For example, the Z6 model is cleared for the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for the implantation of intra-corneal rings and pocket creation for the implantation of corneal implants. The Z6 can also perform lamellar and penetrating keratoplasty or other treatments requiring lamellar resection of the cornea at varying depths.
AMO femtosecond laser gets new approval. AMO has received FDA clearance to use its iFS Advanced Femtosecond Laser to create bow-shaped or curved arcuate incisions in corneal surgery, including cataract surgery, allowing for greater precision than manual techniques.
The iFS Laser is currently used to create LASIK flaps and other corneal incisions in the eye and is the fifth generation of IntraLase technology, which has been used in more than five million procedures worldwide.
CZM to study all-femto refractive technique. Carl Zeiss Meditec announced its intention to initiate a US clinical trial of the ReLEx smile procedure for the correction of myopia, having received conditional approval for the trial from the FDA.
CZM said the new technique for refractive surgery combines femtosecond laser technology and precise lenticule extraction for minimally invasive laser vision correction for the first time – and in a single system: the VisuMax Femtosecond Laser.
While in LASIK procedures the excimer laser vaporizes tissue, the ReLEx smile method generates a refractive lenticule in the intact cornea with the femtosecond laser. The surgeon then removes the lenticule through a small, less-than-4 mm incision without needing to move the patient to an excimer laser.
“We are pleased that we can now start this clinical trial, as it represents the first milestone on our path to make this procedure available to surgeons in the US,” said Dr. Ludwin Monz, president and CEO of Carl Zeiss Meditec AG.
The VisuMax Laser Keratome is currently cleared in the US for creating corneal flaps as well as for lamellar and penetrating keratoplasty for corneal transplantations. VisuMax ReLEx smile, a novel small incision, single-step and all-femto vision correction method, was launched internationally in September 2011.
Vision preservation after cataract surgery. Australian researchers followed 1,936 patients aged 65 years and up who underwent cataract surgery at one Sydney hospital between 2004 and 2007. Presenting and pinhole VA were assessed and retinal photography was performed annually. VA improvement or reduction was defined if VA differed by greater than two lines between one and 24 months.
VA data were available for 1,809 patients at one month and 1,294 at both postoperative visits. At the two-year visit, 930 patients (71.9%) maintained the same pinhole VA levels that they had at one month postoperatively, while 199 (15.4%) had an improvement and 165 (12.7%) a reduction in pinhole VA. After adjusting for age and gender, pre-existing macular conditions (early AMD, macular hole or previous laser treatment) were associated with pinhole VA reduction. At the 24-month visit, 58.1% of those with presenting VA improvement wore distance spectacles.
The researchers, reporting in the British Journal of Ophthalmology, concluded that approximately one in eight cataract surgical patients lost at least two lines in pinhole VA over the two-year postoperative period.
Cataract surgery on Carolina elephant. Recent successful cataract surgery on C'sar, a 38-year-old elephant at the North Carolina Zoo, represented only the fifth time elephant cataract surgery has been performed anywhere in the world. It also marked the first time that an SD-OCT system (Bioptigen's Envisu R2300) was used on an elephant. No artificial lens was implanted in C'sar's eye, as damaged tissue would not support an IOL.
Zoo officials say that C'sar's behavior has improved dramatically since the four-hour surgery. OM