At Press Time

Examining The Learning Curve in Phaco

Study compares experienced surgeon vs. residents.

■ Researchers from the department of ophthalmology at the University of Sao Paulo, Brazil, sought to determine the costs and complications involved in cataract surgery performed by residents at various stages of their training compared to the benchmark set by an experienced cataract surgeon.

In this highly interesting prospective study, recently presented at ARVO, phaco procedures performed by residents during the first three months of training were compared with surgeries performed by an experienced surgeon. Included were 312 surgeries, with residents performing 261 and an experienced surgeon doing 51. The surgeries were divided according to resident surgical experience at the time of performing the procedure (Group 1: 0-40 surgeries, Group 2: 41-80 surgeries and Group 3: more than 80 surgeries).

The mean cost observed in the first 40 resident surgeries was 46.52% higher than the surgeries performed by an experienced surgeon; between 40 and 80 surgeries, the mean cost was 37.58% higher, and in the group with more than 80 surgeries, the mean cost was 19.26% higher. The costs incurred in the resident surgeries were in all stages above the amount paid by the Brazilian public health system.

Regarding the time of surgery, the overall average in surgeries performed by residents was 54.2 ± 23.4 minutes. Average time for the experienced surgeon was 36.0 ± 15.3 minutes. The time observed in Group 1 was 57.6 ± 23.0 minutes; in Group 2 it was 54.6 ± 24.7 minutes and in Group 3 it was 49.0 ± 18.3 minutes. All comparisons were statistically significant.

The complication rate found in surgeries performed by residents was 11.49%. The rate in surgery performed by the experienced surgeons was 1.92%. In Group 1, the researchers observed rates of 9.65% of posterior capsule rupture and 8.77% of vitreous loss; in Group 2, the observed rate was 7.37% of capsule rupture and 4.21% of vitreous loss, and in Group 3 the observed rate was 5.77% of capsule rupture and 3.85% of vitreous loss. These complications were not observed in the experienced surgeon's group.

The researchers concluded that “cataract surgery performed by the residents [shows a statistically significant increase in spending for the service and an increased risk of complications for patients. This difference progressively decreases with the completion of more procedures, demonstrating the effect of training.”

Generic Latanoprost Shows Equivalence

European study: therapeutic value similar to Xalatan.

■ Now that an approved generic version of the market-leading glaucoma medication Xalatan (latanoprost) is becoming available in the US from Mylan Labs, many glaucoma specialists are looking for some assurance that the generic latanoprost will be as effective in lowering IOP as Xalatan.

“This is a major concern,” says Andrew Rabinowitz, MD, glaucoma specialist for the large Barnet Dulaney Perkins practice in Arizona. “We have had experience in the past where the generic was not as effective as the branded glaucoma medication. We may have to wait a few months and obtain some data to see if we can assure patients with confidence that it is OK to use the generic version.”

Though post-approval patient data on the Mylan drug is not yet available, some reassurance may come from a study by Italian researchers presented at the recent ARVO meeting. Because of different patent laws, generic latanoprost has been available in many European countries since last year.

The study was a phase 3, multicenter, prospective, randomized, double-blind, parallel-group clinical trial comparing generic latanoprost (Galaxia) with Xalatan in 185 patients with primary open-angle glaucoma or ocular hypertension, with an IOP greater than 21 mm Hg at the randomization visit.

Patients were instructed to instill one drop in the affected eye(s) every evening at 8:00pm for 12 weeks. The primary efficacy endpoint was the change in IOP (mean of three assessments) from baseline after 12 weeks of treatment.

The two treatments were to be declared equivalent if the two-sided 95% confidence intervals for the difference between adjusted treatment means of the three measurements lay entirely within the interval −1.5 to +1.5 mm Hg.

The researchers found that the mean difference in the reduction achieved with the two treatments was 0.1 mm Hg and its confidence interval (−0.47; +0.71) fell within the interval set for therapeutic equivalence. Both treatments were equally well tolerated and only one patient in each treatment group withdrew from the study due to adverse event.

“This 12-week study demonstrates that the generic Galaxia and Xalatan are equally effective IOP-lowering treatments,” the researchers concluded.

Financial Risk Appended to ACO Law

New regulations to codify ‘Shared Savings Program.’

By Frank Celia, Contributing Editor

■ After a year of repeatedly assuring the medical world that a forthcoming incentive program contained in healthcare reform legislation would entail absolutely no financial risk, only rewards, the federal government proposed regulations this spring that specify how physicians' Medicare reimbursements would be put at risk by participating in this program.

Unveiled on March 31st, the proposed regulations flesh out the section of the Patient Protection and Affordable Care Act (PPACA) of 2010 known as the Shared Savings Program, which aims to provide incentives for reducing costs and providing higher quality care. Lawmakers hope to achieve these goals by encouraging physicians to band together in newly created accountable care organizations. If an ACO achieves certain cost and care benchmarks, the law calls for CMS to reward it by returning a portion of the money saved.

The proposed rules—open to public comment for 60 days before a final version becomes law sometime this year—add the caveat that an ACO that fails to contain Medicare costs within set benchmarks would be responsible for paying back a percentage of those overruns to CMS. Regulators will determine rewards, penalties and benchmarks for each ACO on a case-by-case basis.

For months, practice management experts have warned that some kind of downside would be necessary for the program to work. “The notion that there would only be an upside was kind of motivating a lot of providers to be involved with this initiative,” says Jeffrey Ruggiero, JD, of the law firm Arnold & Porter. “Now some are pausing. For any providers looking for a reason to hesitate, CMS just gave them one.”

Nevertheless, Mr. Ruggiero is advising his clients considering forming ACOs to stay the course. Potential ACO upsides far outweigh the downsides, he says, especially in the first three years when the low-hanging fruit will be easily picked. “One of the things I tell them is it's better to be a player than to be shut out.”

Another concern: the proposed regulations lack a legal structure for tracking Medicare patients within ACO frameworks, to prevent so-called “beneficiary leakage,” i.e., patients moving from one practice to another, thus avoiding utilization discipline and disrupting continuance-of-care benefits.

There is widespread belief the proposed regulations will undergo significant change before the PPACA's Jan. 1, 2012 deadline for having a functional program in place. Healthcare lawyer and consultant David Harlow, of Newton, Mass., said the final rules will likely grow more practitioner friendly. “The ACO rule as written in draft form is very hospital-centric,” he notes. For example, regulators propose at least 50% of all ACO primary care providers demonstrate meaningful use of electronic medical records, a high number given how few currently meet this standard.

He too advocates a catch-the-train-before-it-departs outlook, citing the high number of commercial carriers already devising their own ACO-like payment models. “It could be five years, it could be two years, but at some point this or something like it is going to hit everybody,” Mr. Harlow says. “So sitting it out might make sense for now, but not for the five- or 10-year picture.”

Dealing With Misplaced IOL Haptics

Ultrasound biomicroscopy used to confirm diagnoses.

■ Researchers at the Cole Eye Institute of the Cleveland Clinic performed ultrasound biomicroscopy (UBM) in 14 pseudophakic eyes suspected to have misplaced IOL haptics.

Patients were referred to the institution from May 2009 through September 2010, due to chronic postoperative inflammation, recurrent hyphema, increased IOP, recurrent vitreous hemorrhage or a combination of those. The position of the intraocular lens haptics and their relationships to the surrounding anterior segment structures were determined.

The time from cataract surgery to referral/diagnosis of misplaced haptics by UBM ranged from two to 144 months. Seven patients had sulcus implanted intraocular lens and seven had an in-the-bag intraocular lens. Six patients had a history of chronic postoperative inflammation. Five patients had recurrent episodes of hyphema. Elevated IOP was found in nine eyes. A history of recurrent vitreous hemorrhages was elicited in eight patients.

IOL haptics misplacement was confirmed by UBM in all suspected cases. In 12 eyes, at least one haptic was embedded in or touching the iris. Haptic extension into the ciliary body process was observed in two patients, and into the pars plana in another. Focal iris thinning/atrophy was detected by UBM in three cases. Focal angle-closure associated with haptic misplacement was found in four eyes. IOL exchange was performed in four cases. Out of the nine patients who presented with elevated IOP, seven had it controlled with topical IOP-lowering medications. Two patients were maintained on cycloplegics and topical steroids.

The researchers, who presented their findings at the recent ARVO meeting, concluded that UBM is a valuable tool in confirming the clinical suspicion of misplacement of the lens haptics and haptic-induced ocular irritation after cataract surgery.

“This disorder may remain undiagnosed for several months, mimicking other conditions,” they concluded. “Imaging findings, along with the presenting features, are essential in assisting the physician in the decision making process of management of these patients.”

Akorn Acquires Maker of TheraTears

Agreement creates new opportunities in OTC eyecare market.

By Samantha Stahl, Assistant Editor

■ Niche generic pharmaceutical company Akorn Inc. has agreed to acquire Advanced Vision Research (AVR)—known for its TheraTears dry eye therapy and MacuTrition eye health supplement as its key brand names—for $26 million in cash.

Akorn plans to launch a Consumer Health Division to enter the $1.2 billion OTC eyecare market, as well as licensing new products and developing private label eyecare products for major retail chains. President of the new division is Bruce Kutinsky, PharmD, formerly Akorn's senior VP of corporate strategy.

“We're increasing the presence and renewing the focus of these products in the ophthalmologist and optometrist space,” Mr. Kutinsky says. While Akorn will continue using freestanding inserts to directly connect with the consumer market, the company is also working on new ideas for physicians to purchase and sell products in their practices.

The company plans to expand the TheraTears brand beyond dry eye. Mr. Kutinsky, who is also a former VP of strategic solutions at Walgreens, says that consumers can expect a new product to hit store shelves by the end of the summer.

Akorn's CFO Tim Dick says any new OTC items will complement AVR's existing offerings by targeting red eye and allergy remedies. “We have found the private label market to be rather fragmented, so we think it's the right area to pursue,” he says. He adds that Akorn will expand AVR's professional sales through sampling and a direct sales force. “We can get a face in there talking with ophthalmologists. AVR didn't have that. They did it through mailings,” Mr. Dick says.

“We plan on hitting the consumers indirectly with the physicians sales force approach and want to be able to increase sampling, which is what drives the customer to start using the product,” adds Mr. Kutinsky.

Akorn CEO Raj Rai said in a statement, “We have had a positive relationship with AVR for several years as a primary contract manufacturer. With the acquisition, we can add value in future growth as we have an existing sales infrastructure that markets products to ophthalmologists and retailers nationwide, complementing AVR's sales initiatives.”

The late Jeffrey P. Gilbard, MD, who developed the brand's lead products, founded AVR in 1995. TheraTears, formulated to restore conjunctival goblet cells and corneal glycogen levels and reduce rose bengal staining, was created after Dr. Gilbard spent years researching the tear film at Harvard University's Schepens Eye Research Institute. He went on to single-handedly begin a mail-order business that rapidly evolved into an international company named to Inc. magazine's list of America's 500 fastest-growing privately held companies.

Neil Donnenfeld took over as CEO after Dr. Gilbard died in a tragic bicycling accident in 2009. The company recorded $20 million in sales in 2010, consisting of domestic sales in retail chains, as well as in 20 foreign countries.

Research Digest

New & Noteworthy Journal Articles

Compiled by Andrew E. Mathis, PhD, Medical Editor

► Eye on pediatrics. Ophthalmologists in the UK investigated whether vision impairment in childhood affected quality of life (QOL). Their findings were in the May 2011 issue of the British Journal of Ophthalmology.

The study enrolled 48 children (24 vision-impaired patients of the Oxford Eye Hospital and 24 age- and sex-matched controls). The study group had a mean age of 9.83 ± 2.81 years and consisted of 18 male and six female patients, all of whom were subjected to comprehensive visual rehabilitation and who responded to the Low Vision Quality of Life questionnaire. The most common diagnosis was nystagmus, followed by oculocutaneous albinism and optic atrophy.

After statistical analysis, the authors concluded that QOL scores for the children in the patient group were statistically significantly lower than those for the control group, and this difference was also reflected in all subscale scores. QOL scores were higher for younger children in the patient group, as well as for female patients. A significant correlation was also found between QOL score and level of VA; the better the VA, the better the score.

The questionnaire was limited to vision factors and the QOL scores did not take into account nonclinical factors.

► Infection after PK. Postoperative corneal infection, while rare, is still a major complication of penetrating keratoplasty. However, in a retrospective examination of case files, ophthalmologists at the University of California, San Francisco, report in the June 2011 issue of Cornea that the postop infection rate may actually be lower than previously thought.

Charts from 487 PKs performed on 412 patients treated at UCSF between January 1, 2002, and July 1, 2006 were examined in the article. A total of 22 cases of postop infection were identified, of which five were tagged as suture-related graft infections, i.e., due directly to the keratoplasty, thus yielding an overall postop infection rate due to PK of 1.0%.

Notably, all five cases involved sutures to the interpalpebral zone, nor were any of the patients using topical antibiotics at the time of diagnosis of the infection. Three of the five cases were due to Staphylococcus aureus. Two patients' infections were serious enough to result in phthisis.

Despite the seriousness of the infections identified, the rate reported in this study is lower than the typical rates reported of 2.3% to 4.6%. While the retrospective nature of the study might have limited the universality of the findings, the authors are nevertheless confident that rates have dropped.

► Oxygen for injured eyes. Emergency room physicians often have to treat chemical or thermal burns to the eye, and a specialist might not always be available. Answering this need in part, the May 2011 issue of the American Journal of Ophthalmology includes an article studying the use of oxygen therapy for such burns.

The authors of the study, a team from four medical centers in Iran, retrospectively enrolled 24 eyes of 22 patients with grade 3 or 4 ocular burns who received conventional medical therapy, as well as 13 eyes submitted to 10 L/minute of 100% oxygen for one hour twice daily, using a specially designed mask.

The outcomes of the study indicated that oxygen therapy speeded healing, with the 13 eyes in the oxygen therapy group having their corneal epithelial defects heal in an average of 15.23 ±3.94 days vs. 59.9 ±23.3 days for the conventional therapy cohort. Revascularization of ischemia in injured eyes was quicker in the oxygen therapy eyes, and corneal clarity was better in that group as well. Final visual acuity was better in the oxygen-treated patients, and perhaps most importantly, there were no long-term severe injuries in that group, while three eyes in the other group developed corneal melting, and one other developed corneal adhesion.

Based on their results, the authors of this study strongly urge the use of oxygen therapy in the acute phase burns. If it cannot be started immediately, it should be initiated as early as possible.

► Glaucoma prescribing rates. Ophthalmologists from France and Italy examined data from five European countries to determine changes in prescribing trends for glaucoma medications. They report their findings in the April/May 2011 issue of the Journal of Glaucoma.

The European study team formed three drug classes from their raw data: prostaglandins, beta blockers and other. Among their findings were that, over the period from 1995 to 2006, beta blockers had decreased in market share, while prostaglandins had increased. Predicting that the market share curves of the two categories of drugs would cross over in 2005, they were surprised to find that this prediction did not come true.

Among the reasons the authors hypothesize might explain the failure to predict accurately these trends is the refusal of Italy's government to reimburse patients for prostaglandins as a first-line therapy. Furthermore, beta blockers are still more commonly prescribed in Germany, which also likely affected the late crossing of the market share curves.

The authors thus conclude that European healthcare regulations have had a real effect on the prescribing of drugs for glaucoma. They note that use of prostaglandins is associated with lower rates of surgical interventions in glaucoma patients, and this must be weighed carefully against the savings that countries like Italy have achieved by restricting first-line therapies. The authors close by urging better cost-benefit analyses to help individual patients.

Twenty-year Corneal Graft Survival

Keratoconus patients show best long-term results.

■ Researchers at the Wills Eye Hospital conducted an interesting study in which they went back 20 years and more to determine how many corneal transplants performed prior to 1990 were still viable. Their findings were presented at the recent ARVO meeting.

They initially identified 60 eyes of 42 patients who were treated at Wills with either penetrating or lamellar keratoplasty. The most common indications for corneal transplant in these patients was keratoconus (80%), Fuchs' dystrophy (12%), HSV keratitis (7%) and failed graft (2%). Fifteen percent of these patients had preoperative risk factors such as deep stromal vessels, pre-existing glaucoma or significant cataract.

The researchers found that, after 20 years or more, 34 eyes (57%) still had clear, compact grafts. Twenty-six eyes (43%) had inferior graft-host ectasia beginning at 22 ± 4.84 years postoperatively (range, 13 to 32 years) and three eyes (5%) had subepithelial fibrosis.

At the last visit, mean BCVA was 0.25 ± 0.34 logMAR (20/35 Snellen equivalent) with a mean spherical equivalent of −4.12 ± 4.96 D and mean cylinder of 4.57 ± 2.38 D. Twenty-two eyes (37%) had at least one episode of rejection, which resolved with topical steroids. Other complications included glaucoma (13%), cataract progression (12%), HSV recurrence (8%) and suture abscess (2%).

Researchers concluded that among the common indications for penetrating keratoplasty, keratoconus tends to have excellent graft survival and visual outcome. Development of ectasia and rejection episodes are problems to be encountered in grafts that have survived for more than 20 years.

Eye Injuries More Common in Rural Areas

Statistical report focuses on emergency care.

■ The Agency for Healthcare Research and Quality has recently released its statistical report on the type, causes and geographic locations of eye injuries that required visits to hospital emergency departments (ED), with the data covering complete reporting for 2008. The most significant finding is that residents of rural areas are far more likely to experience an eye injury than their urban counterparts.

Among the highlights are:

There were about 636,619 ED visits related to eye injuries in 2008, for a rate of 209 visits per 100,000 population. About 3.1% of patients seen in the ED for eye injuries were admitted to the hospital-compared to 8.1% of ED visits for all other types of injuries.

ED visits related to eye injuries were 1.7 times higher for males (262 visits per 100,000 population) than females (158 visits per 100,000 population). Almost three-quarters of ED visits related to eye injuries were for patients 44 years and younger (73.6%).

There were more than five times as many ED visits related to eye injuries for patients from rural areas (646 per 100,000 population) than urban areas (120 per 100,000). The rate of ED visits related to eye injuries was highest in the northeast (256 per 100,000 population) followed by the midwest (242 per 100,000 population) and lowest in the west (156 per 100,000 population).

Common causes of eye-injury related ED visits included being struck by an object, falling, fires/burns, motor vehicle traffic and environmental causes. Among cases admitted to the hospital from the ED, falls were the most common cause followed by motor vehicle traffic accident and being struck by an object.

The most common specific eye injury seen in the ED was a superficial injury to the cornea, accounting for nearly half of all eye injuries (48.7%), followed by laceration of the eyelid (9.3%) and bruise of the eye (7.3%). This pattern was also reflected in treat-and-release ED visits related to eye injuries. In contrast, the most common specific eye injuries resulting in admission from the ED included wounds to the ocular glands (16.9%), bruises to the orbital tissues (15.2%) and bruises of the eyelids (11.2%).

Across all ED visits related to eye injuries, the top five causes of eye injuries were being struck by an object such as being hit during a fight or being involved in sports injury (31.1%), falls into an object (10.0%), fire or burns such as from caustic or corrosive substances (4.3%), motor vehicle traffic accident (3.3%) and environmental injuries such as a bite from an insect or animal (3.2%). Some variation was seen in the distribution of the causes of injury for eye injury related ED visits resulting in admission. Falls were the most common cause of injury for such visits (36.1%), followed by motor vehicle traffic accident (19.1%) and being struck by an object (12.0%).

Intraoperative OCT in Canaloplasty

■ German researchers found that using a surgical microscope-mounted OCT camera imaging system called iOCT enabled them to use visualization to conduct more precise canaloplasty procedures in glaucoma patients. Their findings were presented at the recent ARVO meeting.

Nine primary open-angle glaucoma patients were examined with the iOCT (Moeller-Wedel GmbH and OptoMedical Technologies) during routine canaloplasty surgery. The OCT-camera enabled simultaneous real-time OCT imaging of catheterization of Schlemm's canal. Scleral incisions and preparation of Descemet's window were analyzed in real time and reconstructed in 3D and 2D over time. Descemet's window could be visualized in high resolution after surgical preparation. Morphological evaluation with OCT revealed either a round or wedge-shaped pattern of Schlemm's canal. Mean overall suture tension grade was 2.2 (SD 0.6) analyzed by OCT after canaloplasty.

The researchers found that iOCT enables intraop highres OCT imaging of Schlemm's canal during canaloplasty. Intraoperative OCT is useful for suture tension grading and imaging of morphology of Schlemm's canal and enables a direct intraoperative control of the intended suture traction.

“iOCT has the potential to become a new technological tool in different applications, particularly in glaucoma surgery,” they concluded. OM