Though a careful vitreous cleanup can void many of the vision-threatening complications associated with vitreous loss during cataract surgery, the transparency of the vitreous gel makes the job a challenge. Cincinnati surgeons say Kenalog suspension (triamcinolone acetonide) may be able to help.
After successful trials in cadaver eyes, Scott E. Burk, MD, PhD, Andrea P. DeMata, MD, and their colleagues from the Cincinnati Eye Institute used a 27-ga. cannula to inject Kenalog into the anterior chambers of three eyes with traumatic zonular dialysis. Before injection, the surgeons “washed” the Kenalog free of its preservative, benzyl alcohol, with a filter. Two of the three cases developed corneal edema that resolved postoperatively, and the patients’ vision has remained stable. The surgeons have since gone on to use the technique on more than a dozen additional patients.

“Kenalog suspension, when injected into the anterior chamber, provides the surgeon a means for localizing and identifying vitreous gel,” writes Dr. Burk in a description of the technique prepared for Review. “The clear visualization of the vitreous gel allows for thorough removal of the prolapsed vitreous, and alerts the surgeon to residual strands of vitreous, which might have otherwise gone unnoticed. It also allows the surgeon to observe the vitreous behavior so that he or she might avoid maneuvers that increase vitreous traction or prolapse.”

Kenalog-laden vitreous gel streams into the port of the vitrectomy headpiece as the surgeon watches its thorough removal in this eye with a traumatic zonular dialysis.

Surgeons interested in this technique may not have to run the Kenalog through filters in the future. Dr. Burk notes that the New England Compounding Center (Framingham, Mass.) has recently begun producing a preservative-free Kenalog, which should be suitable for the maneuver.

The surgeons offer some caveats about the procedure, though. Steroid-induced glaucoma is a possible complication. A study found that, when intravitreal Kenalog was used for subretinal neovascularization, 30 percent of the 113 patients developed a 5 mmHg or greater rise in intraocular pressure in the first three months.1 The risk may be lower when used during cataract surgery since most of the Kenalog is removed at the time of the anterior vitrectomy. The Cincinnati researchers also note that theirs is an off-label use of Kenalog, and, as such, there may be a need for additional studies of such things as endothelial cell counts.
1. Wingate RJ, Beaumont PE. Intravitreal triamcinolone and elevated intraocular pressure. Aust N Z J Ophthalmol 1999;27:6:431-2.

LASIK Retreatment Tied to Older Age, High Myopia
Patients with high myopia and astigmatism and over age 40 are more likely to undergo a second surgery to correct residual refractive error than those younger than 40 and with lower initial corrections. So says a retrospective study of the prevalence and risk factors for LASIK retreatments. The study appeared in the April issue of Ophthalmology.

In the study, 2,485 eyes of 1,306 patients had LASIK surgery for myopia, hyperopia and astigmatism. Both high myopia and high astigmatism were independent predictors of the need for an enhancement. For instance, a 10-D myope had a retreatment incidence of 14 percent, whereas a 3-D myope had a 7-percent chance of needing enhancement within one year after the initial procedure.

Patients between ages 41 and 50 had a one-year retreatment rate of 14 percent, compared to 5 to 9 percent for those ages 18 to 40. No significant differences in the initial refractive error were found in these two groups.
Of the total cohort, 288 eyes of 233 people received one enhancement, and one eye in each of three participants with myopia required two additional procedures for undercorrection. The overall one-year incidence of a second surgery was 10.5 percent. The retreatment rates for myopic and hyperopic eyes were 12.1 percent and 6.2 percent respectively. No gender differences existed.

Further, approximately 85 percent of enhancements occurred within the first year of LASIK, averaging 7.3 months between initial surgeries and retreatments. Forty-one percent of additional procedures took place between three and six months of the primary correction; the longest was about three years.

The reasons higher initial refractive errors increase the risk for retreatments aren’t clearly understood. Investigators speculate that the common practice of purposely undercorrecting eyes with high myopia, hyperopia and astigmatism to avoid overcorrection is one contributor. The undercorrection often leaves patients dissatisfied with results, so they choose an enhancement to correct any residual refractive error.

Still, other theories prevail. “Greater wound healing, resulting from removing larger amounts of tissue during higher corrections, and the [unpredictable dynamics of] laser-tissue interaction are possible reasons,” says lead researcher Peter S. Kaiser, MD, of the Cornea and Laser Eye Institute in Teaneck, New Jersey. “[In these cases], small errors are magnified with higher degrees of correction.”

In older eyes, the inability to adapt as well as younger eyes to a primary LASIK surgery and poorer lens quality may increase the odds for enhancements. “But that’s not to say that patients over 40 do poorly,” assures Dr. Kaiser. “Their relative risk for a retreatment is greater, but most do quite well without a second correction.”

The study also reported that a manual flap-lifting technique proved successful in the LASIK surgeries. Only three flaps couldn’t be lifted. “A manual technique overall is a safer procedure than a recutting of the first flap. It avoids trauma to the first flap when recutting a second flap with the microkeratome,” says Dr. Kaiser. Further studies comparing manual relifting to flap recutting are necessary, say investigators, to determine the safety and efficacy of the two procedures.

Refractive Surgery Groups Merge
The American Academy of Ophthalmology’s Refractive Surgery Interest Group and the International Society of Refractive Surgery have joined forces to create the first global eye-care organization dedicated to the growing field of refractive surgery.

The new group, the International Society of Refractive Surgery of the American Academy of Ophthalmology (ISRS/AAO), combines the best of both worlds, say leaders of both associations. RSIG catered mostly to a national membership, whereas ISRS served an international constituency.
The broader focus allows the new group to provide scientific research and educational opportunities to refractive surgeons worldwide through seminars, conferences and symposia and to help keep them abreast of cutting-edge surgical techniques that they can incorporate in to their daily practices, says Jack T. Holladay, MD, MSEE, FACS, clinical professor of ophthalmology at Baylor College of Medicine.

Membership now comprises approximately 2,500 people from more than 80 countries as a result of the merger.

“Having ISRS and RSIG come together as one organization gives us a greater opportunity to truly globalize education for refractive surgeons,” says H. Dunbar Hoskins Jr., MD, executive vice president of AAO. “Refractive surgery is evolving more rapidly outside the United States than inside, so by involving people from all around the world, we’ll accelerate the transfer of educational information to refractive surgeons.”

ISRS board member Guy Kezirian, MD, adds that with that evolution, the union of the two groups makes more sense than ever. “Refractive surgery is mainstream today,” he says, “and as the procedure and science have advanced, ISRS has become the model for research and innovation.”

Since forming an alliance, the two associations have established a 12-person executive committee—six from ISRS and six from RSIG. James Salz, MD, past president of RSIG, has been named committee chairman of ISRS/ AAO. Dr. Holladay, former president of ISRS, is vice chairman.

Previous RSIG members serving on the new committee include Dan Durrie, MD; Steve Wilson, MD; Helen Wu, MD; Terry O’Brien, MD, and Steve Schallhorn, MD. Those representing ISRS are Michael Lawless, MD; Akef El Maghraby, MD; George Waring, MD; Jorge Alio, MD, and Francesco Carones, MD.

The idea to integrate the two refractive surgery organizations took root when members and speakers would try to attend both ISRS and RSIG annual meetings that ran simultaneously. The inconvenience led many people to question the need for two associations with very similar objectives, says Dr. Hoskins.

For ISRS, the decision to merge with RSIG was a matter of survival. When Dr. Holladay became president in January 2002, the society was $400,000 in debt and membership was down from 3,500 to 1,900. “It was a pretty dismal outlook,” says Dr. Holladay. “We were forced to look for ways to form an alliance with another organization. So we began to look at other alternatives. And what emerged was a possible association with AAO.”

In April 2002, leaders from ISRS and AAO met to discuss a possible merger at the International Council of Ophthalmology meeting in Australia, where they agreed an alliance would be beneficial. “ISRS had approximately 2,000 members. RSIG had about 500 to 1,000. So the idea of coming together and growing our membership to 3,000 was very exciting for us and for them,” says Dr. Holladay. “AAO was interested in broadening its international activities in all areas, including refractive surgery. It appeared to be a win-win for everyone.”

ISRS’s terms of agreement with RSIG include equal representation on the new executive committee; keeping the society’s Journal of Refractive Surgery and editorial offices intact until the end of 2003; and permission to host its annual awards dinner during subspecialty day, says Dr. Holladay.

RSIG simply wanted ISRS debt-free. Eventually, all terms were satisfied. The debt was relinquished, and the organizations merged. “With the help of our board and executive committee, we were able to raise almost $250,000 from corporate sponsors. We were able to get rid of the remaining debt through annual sponsorships and our membership drive.”

Since joining forces, the ISRS/AAO has begun planning its first joint meeting, scheduled November 14-15, 2003, in Anaheim, Calif. “Our meeting will be the most spectacular program for refractive surgery yet,” says Dr. Holladay. “Our joining together is going to benefit industry and refractive surgeons more than ever before.”

Medicare Reimbursement for Alcon Silicone Oil
Alcon’s Silikon 1000 silicone oil has been granted “pass-through” reimbursement status under Medicare’s hospital outpatient prospective payment system, when used in hospital outpatient surgical procedures. The product is used as a postop tamponade following vitreoretinal surgery for cases of complicated retinal detachment.

Silikon 1000 is a highly purified long chain polymethylsiloxane trimethylsiloxy terminated silicone oil. It is sterile, clear, non-pyrogenic, colorless and has a viscosity of 1000 centistokes. Composed of silicone, oxygen, carbon and hydrogen atoms, Silikon 1000 is immiscible with aqueous components and is a relatively inert material with little biological toxicity potential. Alcon reports that the product offers improved ease of use and efficacy over other tamponade products, as well as earlier patient visual rehabilitation.

The pass-through system is an attempt by Congress to ensure that reimbursement for certain new devices is at an amount as close as possible to the true cost of the device and to give the Centers for Medicare & Medicaid Services the opportunity to collect data on the use of the new technologies. Nicole Sheeler, marketing manager for vitreoretinal products at Alcon, says this is the first silicone oil to receive reimbursement status and just the third new ophthalmic device to do so under the pass-through system.

The reimbursement status for such devices, however, is not permanent. After two to three years of data collection, the status is reviewed and not all products are guaranteed to receive on-going reimbursement.

“We urge surgeons to use the code so that CMS will continue to reimburse,” says Ms. Sheeler. “As part of a pass-through, it is reimbursed from a pool that includes not just ophthalmic but other medical devices and the agency monitors the usage during the review.”

The ruling was effective April 1, 2003, and the code for billing is C1814.