Today’s IOLs provide new options for patients as well as practitioners

Issue: June 2000

With tools such as the Internet at the disposal of so many patients, practitioners are finding it has become more important than ever to stay abreast of new medical developments. Today’s patients are researching new options in eye care such as laser in situ keratomileusis (LASIK) and purchasing contact lenses and eyeglass frames online. While cataract surgery has been mainstream for awhile, new IOLs and other developments in the field have patients presenting with more well researched questions and knowledge than ever before.

“With patients having so much information via the Internet, it really behooves the OD to be knowledgeable for two reasons: patients know what’s out there and know about what their comanaging surgeon chooses to use,” said Paul M. Karpecki, OD, clinical director of cornea and refractive surgery for Hunkeler Eye Centers. “You could have all of the information about one lens, only to have the surgeon never recommend it or not know how to use it. Be more knowledgeable than the patients in these new areas. This is achieved mainly by calling the surgeon and asking what he or she is using. Communication with the surgeon keeps the care consistent; everyone looks like they’re on the same page.”

Publicity about various procedures also makes the patient more aware of increased options, said Maynard L. Pohl, OD, clinical director of Pacific Cataract & Laser Institute in Bellevue, Wash. “An increasing number of patients are developing a heightened awareness regarding their eye care options, primarily as a result of the attention eye care is receiving by the media,” he said. “Consequently, it is important for primary eye care practitioners to be able to clinically identify the informed yet suitable candidate for a particular type of specialty IOL.”

Toric intraocular lenses

A relatively new breakthrough in the field of IOLs is the STAAR Surgical Elastic Ultraviolet-Absorbing Silicon Posterior Chamber IOL with Toric Optic, or toric lens, which hit the U.S. market early in 1999. Designed to reduce pre-existing astigmatism in cataract patients, this is the only IOL that has received FDA labeling stating that the lens can improve uncorrected visual acuity.

The STAAR Toric was granted a “new technology” designation by the Health Care Financing Administration (HCFA) in May of this year. This designation will increase reimbursement by $50 per lens above the standard Medicare reimbursement to ambulatory surgery centers when they use the “new technology IOL.” Reimbursement increased as of May 18 and will be paid through May 18, 2005.

“This lens has been a tremendous improvement in the predictability of treating pre-existing astigmatism in cataract patients,” Stephen Bylsma, MD, in private practice in Santa Maria, Calif., told Primary Care Optometry News. “The predictability has been the biggest factor in gaining a known amount of improvement in astigmatic correction. Optically, it seems to be very stable as opposed to some of the other corneal procedures, as they can change over time, sometimes even de-stabilizing the cornea. It’s nice to leave the cornea alone and address the pre-existing astigmatism optically with the toric IOL.”

Practitioners must be wary of the potential for rotation from the intended axis, cautioned John Vukich, MD, in group practice in Madison, Wis. “There really is no practical difference in terms of how it’s inserted or the surgery itself,” he said. “The only difference is that it needs to be oriented. Once inside the eye, it must have an axial orientation, unlike most other IOLs. So there is that additional step. It’s very unlikely it will rotate once it’s placed properly, but at some point during the early postoperative period – during the first week – there should be a dilated pupil exam to make sure that is the case.”

According to the Federal Register, when HCFA was determining which lenses met the criteria of the new technology IOL, the agency “relied on clinical data and evidence submitted to the Food and Drug Administration (FDA) by the various manufacturers demonstrating that these lenses have specific clinical advantages and superiority over existing lenses. These claims must be approved by the FDA for use in advertising and labeling.”

The toric IOLs, biconvex optical lenses for implantation within the capsular bag following phacoemulsification, are available in powers of 4 D to 35 D in 0.5-D increments, with a cylindrical power of 2 D and 3.5 D in the long axis of the lens.

Collagen-based lens

STAAR Surgical received FDA approval in April for the Collamer IOL, a proprietary biotech material comprised of collagen and water that is shown to be biocompatible with ocular tissue. The material, which is shared by the implantable contact lens (ICL), results in reduced irritation and debris, said Dr. Vukich.

“It has a very low tendency to cause inflammation and virtually no tendency to accumulate inflammatory debris,” he said. “This lens has been conclusively shown to have a lower incidence of posterior capsular opacification as well as less difficulty with inflammatory precipitate formation.”

The foldable monofocal lens allows for corrections between –4 and +33 D and varies in length to accommodate the natural shape of the human eye. A total of 686 lenses were implanted as part of a study concluded in 1998. Plans are underway to create a toric with the Collamer material, said Dr. Bylsma.

One-piece AcrySof

In January, Alcon (Fort Worth, Texas) received approval to begin marketing their new AcrySof Single Piece SA30 IOL to clinicians across the country. The new open-loop lens design now incorporates the haptics as a part of the lens, as opposed to the conventional three-piece design. The FDA approved the lens on Sep. 23, 1999.

During the annual American Academy of Ophthalmology meeting in Orlando, Stephen F. Brint, MD, of the Tulane University School of Medicine, explained his perceptions of the new single-lens IOL during a presentation at the Alcon booth.

After performing roughly 75 to 80 implantations, Dr. Brint said he felt confident that the new IOL had made insertion much easier.

The AcrySof Single Piece boasts a 5.5-mm diameter and measures 12.5 mm total length from haptic to haptic. The IOL has an adjustable haptic configuration and an anterior asymmetric optic. Its diopter range is from +10 D to +30 D, available in 0.5 D steps.

The single-piece IOL is seamless, with no gaps or cracks to trap cellular debris. However, the real bonus of the lens, according to Dr. Brint, is the highly malleable and twistable haptics. Because of the memory and flexibility of the AcrySof material, these haptics can be bent back on themselves, twisted and contorted to a much greater degree than multi-piece PMMA haptics.

“The haptics do not permanently deform when going through a tight incision and won’t break going through the injector. Once inside, the IOL expands beautifully to conform to the bag,” said Dr. Brint, as quoted in Ocular Surgery News (“Alcon receives approval to market new single-piece IOL,” January 15, 2000, page 16.)

FDA approves Sensar

The Sensar AR40 (Allergan; Irvine, Calif.), a hydrophobic acrylic foldable IOL, received FDA marketing approval earlier this year. The lens has been shown to have excellent biocompatibility and achieves remarkable visual acuity, according to a recent study.

“I like this lens very much. I have implanted a version of it for 5 years now,” said Tobias H. Neuhann, MD, an anterior segment surgeon in private group practice in Munich, Germany, as quoted in Ocular Surgery News (“Sensar demonstrates ‘excellent’ biocompatibility, study shows,” Nov. 15, 1999, page 40.) “The Sensar behaves very similar to a PMMA lens because it has about the same refractive index (1.47), the same center thickness and nearly the same optic configuration.”

The Sensar, a three-piece thermoplastic lens, has a 6-mm optic for all diopters and a 13-mm lens diameter, along with a modified C-loop PMMA haptic and a UV blocker. “The lens surface also has a slight tackiness, which appears to produce a good seal with the posterior capsule, thus significantly reducing the capsular shrinkage syndrome,” Dr. Neuhann said.

Array receives FDA designation

The Array multifocal lens (Allergan), which received FDA approval in 1997, was awarded “new technology” designation by the Health Care Financing Administration (HCFA) on May 3. HCFA, which administers the Medicare program, will now grant additional reimbursement to ambulatory surgical centers and hospital outpatient departments that provide new technology IOLs to their patients.

The silicone lens, boasting a refractive design with multifocal power on the anterior surface, was also the subject of new data presented at the American Society of Cataract and Refractive Surgery symposium in Boston last month. In the direct comparison study, Michael G. Woodcock, MD, concluded that the predictability associated with the Array was superior to that of LASIK when LASIK was studied leading its first approval by the FDA.

The presentation, taken from studies of 244 consecutive eyes for the Array and 1013 for LASIK, found that 92% of Array patients came within 0.5 diopters of reaching optimum vision as opposed to 57% of LASIK patients.

OD/MD preoperative consultations

Corneal topography is a useful tool for preoperative evaluations of the patient, particularly when using the new toric IOL, said Dr. Bylsma. “For those comanaging ODs who don’t have topography, we do it here,” he said. “The toric IOL can be placed just based on cornea readings, but we do like to verify the steep corneal axis with topography, which helps to align the IOL in the proper axis.”

It is important for the comanaging doctor to be armed with a working knowledge of all available lenses for cataract surgery, said Dr. Pohl. “In an ideal comanaged eye care system, the referring doctor should be familiar with all surgical options for his or her patient, including specialty intraocular lenses, and be willing and able to discuss such options with the patient prior to the time of surgery,” he said.

Most surgeons will be quite receptive to the suggestions of the comanaging optometrist, Dr. Vukich said. “Most surgeons who work with comanaging doctors are generally very receptive to recommendations that would improve their patients’ final outcome,” he said. “The surgeons generally understand and know that the comanaging doctor is going to be caring for the long-term needs of the patient in terms of the spectacle correction, if any, and the final visual rehabilitation. They respect that and will usually honor those types of requests.”

Preoperative consultation helps present a united front and instill confidence in the patient, he said. “Patients want to have confidence in their comanaging doctors as well as their surgeon, and the first thing to take away that confidence is if there are a lot of differences in what each one says, or what one says and the other does,” said Dr. Karpecki. “Aligning that consistency just creates a much better package for the patient.”

For Your Information:

Paul M. Karpecki, OD, is clinical director of cornea and refractive surgery for Hunkeler Eye Centers. He may be reached at Hunkeler Eye Centers, 5520 College Blvd., Overland Park, KS 66211; (913) 491-3737; fax: (913) 469-6686. Dr. Karpecki has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Maynard L. Pohl, OD, is clinical director of the Pacific Cataract & Laser Institute in Bellevue, Wash. He may be reached at 10500 NE 8^th St., Ste. 1650, Bellevue, WA 98004-4332; (800) 926-3007; fax: (425) 462-6429; e-mail: mpohl@pcli.com. Dr. Pohl has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Stephen Bylsma, MD, is a clinical faculty member at the University of California at Los Angeles and is in private practice. He may be reached at 1414 East Main St., Santa Maria, CA 93454; (805) 925-2637; fax: (805) 347-0033. Dr. Bylsma has no direct financial interest in any of the products mentioned in this article. He is a consultant for STAAR Surgical Co.

John Vukich, MD, is an assistant clinical professor at the University of Wisconsin Medical School and is in private group practice. He may be reached at Davis Duehr Dean, 1025 Regent St., Madison, WI 53715; (608) 282-2000; fax: (608) 282-2048. Dr. Vukich has no direct financial interest in the products mentioned in this article. He is a consultant for STAAR Surgical Co.

Stephen F. Brint, MD, can be reached at Brint Vision Correction Center, 3901 Veterans Blvd., Metairie, LA 70002; (504) 888-2020; fax: (504) 887-8166; e-mail: brintmd@aol.com. Dr. Brint has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Tobias H. Neuhann, MD, can be reached at AAM Augenklinik am Marienplatz 18/19, Munich 80331, Germany; (49) 8-92-30-889-0; fax: (49) 8-92-30-889-10; e-mail: tneuhann@aol.com. Dr. Neuhann did not participate in the presentation of this article.

The Toric IOL and Collamer lenses are available from the STAAR Surgical Company, 1911 Walker Ave., Monrovia, CA 91016-4816; fax: (800) 952-4923; Web site: www.staar.com.

The Sensar AR40 and the Array Multifocal lenses are available from Allergan, 2525 Dupont Drive, P.O. Box 19534, Irvine, CA 92623-9534; (714) 752-4500; fax: (714) 955-6987.

The AcrySof Single Piece IOL is available from Alcon International, 6201 South Freeway, Ft. Worth, TX 76134; (817) 551-6828; fax: (817) 568-7116.