Phakic IOLs highlight New York symposium

Verisyse approval first publicly announced at OSN meeting.

Capt. Steven C. Schallhorn, MD spoke about refractive surgery in military personnel at the meeting.

NEW YORK — Phakic IOLs were a hot topic at this year’s Ocular Surgery News Symposium: Cataract, Glaucoma and Refractive Surgery. The day before the meeting began, the Food and Drug Administration approved the Verisyse phakic IOL for the treatment of patients with myopia, officials from Advanced Medical Optics and Ophtec announced, making it the first phakic IOL approved for use in the United States. The lens is approved with a range of –5 D to –20 D, with up to 2.5 D of astigmatism.

Richard L. Lindstrom, MD, Chief Medical Editor of Ocular Surgery News, has been studying the lens in clinical trials for about 6 years. “It will be nice to have patients have access to it outside of clinical trials. It should be the treatment of choice for extreme myopes,” Dr. Lindstrom said at the meeting, where the approval was first publicly announced.

The Verisyse lens is manufactured by Ophtec. AMO obtained exclusive distribution rights to the lens in the United States and Japan in 2002 and markets the lens under the name Verisyse. Ophtec distributes the lens in other markets under the name Artisan.

AMO is currently coordinating surgeon training and certification for the Verisyse lens in the United States and expected to begin releasing the product to trained surgeons by October, according to a joint press release issued by AMO and Ophtec.

According to AMO officials, there are 121 surgeons in the United States who are trained to implant this lens. The company projects that there will be about 200 trained surgeons in the United States by the end of the 2004, with between 400 and 500 trained surgeons in the United States by the end of 2005.

Other news regarding phakic IOLs was also presented at the meeting.

While LASIK is the current procedure of choice for the correction of refractive errors, “multifocal and phakic IOLs will have an impact on your practice in the near future,” said Eric D. Donnenfeld, MD.

Dr. Donnenfeld spoke about 10 ways to integrate phakic IOLs into an ophthalmic practice. Phakic IOLs, he said, give “high patient and surgeon satisfaction.” A study of 412 patients implanted with phakic IOLs showed about 90% would recommend the surgery and an equal percentage were satisfied with the outcomes 1 year postoperatively.

It is a safe procedure with long-term follow-up, Dr. Donnenfeld noted, and the lenses have been used in Europe for more than a decade. Also, PMMA optics “are better than corneal ablative procedures,” he said, and patients’ contrast sensitivity remains unchanged or improved, which is not always the case after a laser procedure.

The procedure and enclavation are easy, he said. Additionally, there is an “extraordinary ‘wow’ factor when you can take a –18 D patient and bring them to plano,” he said. “It’s a life-changing event.”

Dr. Donnenfeld believes the future of refractive surgery is IOLs, and by combining phakic IOLs with LASIK, patients can “achieve extraordinary visual results.”

Better than refractive surgery

Phakic IOLs offer better optical quality for patients than refractive surgery, said Sheri Rowen, MD.

“The ‘wow’ factor is that the patient is now seeing clearly through their own cornea,” she said. Unlike corneal refractive surgery, however, phakic IOLs can be reversed if necessary.

“You can over- and undershoot your IOL calculations for patients with cataract and previous LASIK,” she said.

She spoke about the FDA-aaproved Verisyse/Artisan lens and the Visian ICL (STAAR Surgical), which is awaiting U.S. Food and Drug Administration approval and has been submitted for the treatment of myopia ranging from –3 D to –20 D. In a clinical trial of 479 patients, “after 3 years with the Visian, 97% said they would have the surgery again,” Dr. Rowen said.

Other news from the meeting follows.

Family, friends pay tribute to ophthalmic pioneer Charles D. Kelman, MD

Reported by Nicole Nader NEW YORK — Family members and friends of the late Charles D. Kelman, MD, gathered at the St. James Theater on September 13 to celebrate the life and career accomplishments of the father of phaco — one of ophthalmology’s most influential contributors of the 20th century. Dr. Kelman died of lung cancer on June 1; he was 74. Mourners gathered outside the St. James Theater in Manhattan for a special memorial service for Charles D. Kelman, MD. Among his many achievements were being inducted into the National Inventors Hall of Fame earlier this year, receiving the national Medal of Technology from President George H.W. Bush in 1992 and receiving the American Academy of Ophthalmology Achievement Award in 1970. The memorial, sponsored by the Dr. Charles and Ann Kelman Family Foundation Inc., was not a somber reverie, but a jubilant celebration of the life of a modern-day renaissance man — a man whom friend and television journalist Frank Field, MD, called “a man for all seasons.” Manus C. Kraff, MD, who also spoke at the memorial, said the magnitude of Dr. Kelman’s accomplishments “is difficult to comprehend.” “Charlie was one of those rare multifaceted people who you meet in life,” he said. Other orators who shared personal remembrances of Dr. Kelman included H. Dunbar Hoskins Jr., MD; William Tasman, MD; Robert J. Stevens, vice president of surgical products at Alcon; Dr. Kelman’s wife, Ann; and Dr. Kelman’s children. Not just a renowned ophthalmologist and innovator, Dr. Kelman was also an accomplished saxophonist, singer/songwriter and composer. His credits included appearances on “The Tonight Show” with Johnny Carson, “The David Letterman Show” and “The Merv Griffin Show” as well as performances in Carnegie Hall and Las Vegas. He performed with musical greats Dizzy Gillespie and Glen Campbell and comedian Regis Philbin. The memorial service was accented by musical interludes and video performances by Dr. Kelman, as well as live musical performances of songs he wrote and composed for his theater productions, “The Marrano” and “The Right Pair of Shoes.” At the end of the memorial, attendees praised the man who gave sight to millions and put music in the hearts of many. The tribute culminated with a standing ovation for his life’s works in the way that “Charlie” would have wanted it – on Broadway.

Cataract Surgery

No spherical aberration induction

A new IOL from Bausch & Lomb that is about to enter trials is designed to be “free of spherical aberrations completely,” said Louis D. Nichamin, MD.

Dr. Nichamin said the B&L SofPort AO (Advanced Optics) is an aberration-free lens that does not contribute additional spherical aberration after implantation. “It’s a uniform power from center to edge,” he said. Further, the lens will optimize image quality “irrespective of idiosyncratic spherical aberration or previous surgery with no induction of higher-order aberrations,” he added.

Even when IOLs are perfectly centered in the bag or behind the pupil, “they’re still decentered with regard to visual axis,” Dr. Nichamin said.

For instance, the Tecnis 9000 (AMO) “really shines” when it’s implanted in a 4-mm pupil and perfectly centered, he said. Decentration eradicates the advantage of the Tecnis, he said. When the SofPort AO enters trials, Dr. Nichamin hopes to show the lens is immune to adverse optical effect of lens decentration.

He said the lens will be entering trials shortly.

B&L accommodative lens

An accommodative lens from Bausch & Lomb has been shown to have minimal movement in the eye and to provide “clinically significant outcomes,” according to a speaker.

John D. Hunkeler, MD, described the Sarfarazi accommodative IOL as an elliptical silicone-based dual-lens IOL that undergoes change in accommodative power in response to movement of the optic separator.

Dr. Hunkeler said this lens will continue to be investigated.

Glaucoma

Evaluating patients

Clinicians are doing a better job of glaucoma diagnosis and management, but there are still some past glaucoma-residency doctrines that must be put aside, Harry A. Quigley, MD, said.

L. Jay Katz, MD at the Ocular Surgery News Symposium: Cataract, Glaucoma and Refractive Surgery said some of the limitations of ALT include a waning effect with longer follow-up and the lack of repeatability of the procedure. Images: Archer ME; Liberatore MD

“About half of glaucoma patients in any population rarely have a pressure above this magic number [21 mm Hg] that I am not going to say out loud anymore because I want you to dump that number,” Dr. Quigley said. “It is a meaningless value.”

But IOP does matter even when it is normal, he said. IOP is an indicator of severity and progression rate of the disease.

Dr. Quigley noted that in the past when evaluating a patient for glaucoma, he would get the patient’s IOP during a slit-lamp exam. If the patient had a pressure below 21 mm Hg, perhaps he would look at the optic disk, but would not order a gonioscopy or a visual field test.

“And that’s the way to miss half or more of the patients with glaucoma. If you don’t pay special attention to see if the disk is normal or not, you are definitely going to miss a lot of people,” he said.

Also, clinicians need to look carefully at a population that is at increased risk of having glaucoma – the family members of known glaucoma patients, he said.

“Do you know that more than half of my [glaucoma] patients’ siblings have not had an eye exam for glaucoma?” Dr. Quigley said. The message that glaucoma is a familial disease is not getting through to patients, he said.

Improving compliance

Relating to glaucoma patients can help improve compliance, according to one clinician.

“You have to find the most effective first-line therapy for them,” Alan B. Robin, MD, said.

Dr. Robin also recommended changing glaucoma medication as infrequently as possible and prescribing the least number of medications possible.

He cited some statistics from a study conducted from 1965 to 2001 in Olmsted County, Minn., in which 23% of 2,440 patients did not fill a prescription for any glaucoma medication over a 12-month period after the initiation of therapy. He added that the mean number of days without therapy during the study year was 112.

Dr. Robin said the data show that 22% of all Americans do not fill at least one prescription to save money. If patient income is less than $25,000 annually, the study showed, 40% did not fill at least one prescription, and 30% took a medication less often than prescribed.

SLT, ALT, medication

Attendees visit the exhibit hall at the Ocular Surgery News Symposium: Cataract, Glaucoma and Refractive Surgery, which was held in New York on Sept. 11 and 12, 2004.

Selective laser trabeculoplasty for open-angle glaucoma gives results comparable to argon laser trabeculoplasty or medication, one surgeon said.

“IOP reduction may be more dramatic in eyes without medication,” according to L. Jay Katz, MD.

Dr. Katz said some of the limitations of ALT include a waning effect with longer follow-up and the lack of repeatability of the procedure. On the other hand, he said, the short laser pulses from SLT confine the heat to the target area.

In a small study of 45 eyes (31 patients), those who received SLT had a mean IOP reduction of 7.7 mm Hg as compared to a mean reduction of 5 mm Hg in patients who received drops.

Further study is needed, Dr. Katz said.

Repeat abnormal tests

Clinicians should be more critical in testing for progression of glaucoma, according to Dr. Quigley.

“If the first field test is normal, believe it, “Dr. Quigley said, “but if it’s abnormal, repeat it.” Dr. Quigley explained that 50% of abnormal tests turn out to be normal on repeat tests.

He added that four or more field tests are needed to show that the disease is worsening.

“You can’t judge progression from only one test,” he said.

Refractive Surgery

Zyoptix XP microkeratome

The new Zyoptix XP microkeratome is designed to provide optimum flap depth predictability and consistency, Elizabeth A. Davis, MD, FACS, said.

The Bausch & Lomb microkeratome is an enhanced version of the Hansatome microkeratome, “so there’s a very small surgeon learning curve,” she said.

With the XP microkeratome, Dr. Davis said, "there is no external gear system. There’s no jamming because nothing is exposed.” A pilot study comparing flap thickness cuts between the XP and the Hansatome on pig eyes showed increased precision with the XP.

A prospective human trial has been designed to include 768 eyes of 384 patients; there will be eight study centers involved in the trial, she said.

“Experienced Hansatome surgeons will have little trouble adjusting to the new microkeratome,” Dr. Davis said. Bausch & Lomb plans on demonstrating the new device at the American Academy of Ophthalmology meeting, she said.

Refractive Cataract Surgery

Patient-centered approach

Richard L. Lindstrom, MD, Chief Medical Editor of Ocular Surgery News, spoke on this year’s hot topic — phakic IOLs.

Surgeons who perform lens implants for the correction of presbyopia will be better off asking which IOL is best for the patient instead of which patient is best for the procedure, advised William F. Maloney, MD. He spoke at the meeting on his changed philosophy.

If physicians take a patient-centered approach, “you’ll have much greater success and you can offer this significant advance to a much wider group of candidates,” he said.

Several goals must be met by the surgery, he said. The most important is emmetropia. “Without emmetropia, presbyopic correction will be significantly compromised,” he said. “You need to calculate your lens implant so the spherical error is minimized to ±0.25D.” Dr. Maloney credited Warren Hill, MD, with teaching him that this is possible.

Other goals include no induced astigmatism and no capsular rupture, he said.

Above all else, Dr. Maloney said, is matching the right IOL to the patient. “If you match up the two precisely, you’ll have a satisfied patient each and every time,” he said. Surgeons need to get to know their patients “more intimately” than they do with cataract surgery, he added. Once a patient understands that he or she cannot have everything from reading acuity to night driving acuity restored to pre-presbyopic levels, the patient’s priorities and expectations change. Leave it up to the patient to prioritize what he or she wants, Dr. Maloney said.

Multifocal IOL implantation involves neuroadaptation on the part of the patient, he said. The patient’s brain “doesn’t locate the blur and focuses on it, but rather in my opinion, the brain focuses on the clarity and reinforces it,” he said.

In general, Dr. Maloney added, he prefers the Array Multifocal IOL from Advanced Medical Optics for patients with large pupils and the ReStor lens from Alcon for patients with smaller pupils.

LRIs beneficial

In refractive lens exchange, achieving near emmetropia is essential for success, said one surgeon. To achieve emmetropia, limbal relaxing incisions can be an important component of surgery, Steven J. Dell, MD, said.

Modifying the standard cataract incision with limbal relaxing incisions (LRIs) is a simple technique to learn, Dr. Dell said.

“LRIs are quick, safe, inexpensive and stable,” he said.

In general, LRIs provide patients with “less discomfort, glare and irregular astigmatism than corneal relaxing incisions do,” Dr. Dell said.

In his practice, Dr. Dell uses LRIs for anything over 0.5 D of corneal cylinder. “It’s always in the steep meridian,” he said. When performing LRIs, undercorrections are preferred, and 4 D is “about the limit for LRI,” he added.

Meeting attendees pause to remember 9/11 tragedy

Reported by Mary E. Archer, ELS NEW YORK – During presentations here at the Ocular Surgery News Symposium: Cataract, Glaucoma & Refractive Surgery, a moment of silence was observed at 8:46 a.m., in honor of the events of September 11, 2001. “I suspect we have a few people here who were closely touched by this tragedy,” said Richard L. Lindstrom, MD, program chairman. “Hopefully, we will try to keep this from happening again.” William W. Culbertson, MD, a presenter at the meeting, said to the physician attendees, “These are very sobering times.” Presenter Joel S. Schuman, MD, said, “It is good to be here, but this is a sad time right now.” Ronald L. Gross, MD, who also presented, said, “It is wonderful to be in New York on September 11th and 12th, it really is.”

Retina

Triamcinolone and PDT

Combining intravitreal triamcinolone with standard photodynamic therapy for the treatment of patients with age-related macular degeneration resulted in equivalent outcomes and fewer re-treatments than standard PDT treatments alone, said one surgeon.

When physicians encounter choroidal neovascularization, “we think of it as inappropriate vessel growth, but your body thinks it’s normal growth,” Richard Spaide, MD, told attendees.

To treat AMD with CNV, physicians try to eradicate blood vessels, “but we’re doing things to stimulate their growth,” Dr. Spaide said.

In a small study of 15 patients with CNV in AMD, all underwent PDT plus intravitreal triamcinolone. Follow-up was 12 months. Thirteen patients had juxtafoveal CNV, Dr. Spaide added. The average age of these patients was 79.9 years, and after an initial treatment, all had a visual acuity of 20/50 or better. Only one patient required re-treatment. Patients had a mean best corrected visual acuity of 20/40 with no loss of acuity, Dr. Spaide said.

The downside of the study is its small sample size and the short-term results. Dr. Spaide said that three clinical trials are currently under way to compare triamcinolone plus PDT to traditional PDT alone.

Investigating triamcinolone

The Cataract Surgery Session Panel at the Ocular Surgery News Symposium: Cataract, Glaucoma and Refractive Surgery.

A formulation of triamcinolone specifically for intraocular use will begin trials shortly in patients with retinal vein occlusion, said Michael S. Ip, MD.

The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) study, funded by the National Eye Institute in 2003, will be a randomized, controlled, multicenter trial designed to gather definitive data on the potential benefits and risks of intraocular triamcinolone, Dr. Ip said.

“Triamcinolone injections are used frequently among ophthalmologists,” he said, but there is “no definitive data on safety or efficacy, especially long term.”

Using triamcinolone intraocularly is currently an off-label use, as it is labeled for use intramuscularly, he said. Potential ocular problems with Kenalog (triamcinolone acetonide, Bristol Myers Squibb) are that it may cause a sterile endophthalmitis that is “difficult to distinguish from infectious endophthalmitis” and that its excipients include benzyl alcohol, carboxymethylcellulose and polysorbate 80, Dr. Ip said.

For the SCORE study, Dr. Ip said, a new formulation of the drug, manufactured by Allergan, will be used. Patients will be randomly assigned to 4 mg or 1 mg dosing of triamcinolone or standard care for treatment of macular edema associated with central retinal vein occlusion and branch retinal vein occlusion. All patients involved must be at least 18 years and have center-involved macular edema due to CRVO or BRVO for at least 3 months but not longer than 18 months.

“If the results from this study are positive, it may result in a new treatment for retinal vein occlusion. If the results are negative, it will discourage the use of a commonly used treatment,” Dr. Ip said.

Wavefront

Custom surface ablation vs. LASIK

An analysis of military personnel who underwent refractive surgery found customized surface ablation results to be comparable to LASIK results over the short term, said Steven C. Schallhorn, MD.

“We’ve never randomized patients to surface ablation or LASIK,” he said. “Only patients who were okay with the idea were included.” As a result, 50 patients from the Naval base in San Diego and the Air Force base in San Antonio were enrolled. Those who underwent advanced surface ablation had a mean age of 32 years; those undergoing LASIK had a mean age of 33 years. All patients were similar in terms of sphere, cylinder and manifest spherical equivalent, Dr. Schallhorn said. At 3 months postop, 92% of patients who underwent custom surface ablation and 98% of patients who underwent LASIK achieved 20/20 or better visual acuity.

“At 6 months, there was no nomogram difference between PRK and LASIK in manifest spherical equivalent,” said Dr. Schallhorn. On average, both groups had a postop uncorrected visual acuity equal to their preop best corrected visual acuity.

“About the same boost is required for PRK as LASIK for the nomogram; the Food and Drug Administration says 4.5%, and we found about 5%,” he said.