GP ANNUAL REPORT

GP Annual Report 2010

A summary of GP lens trends and developments as well as a look at where GP lenses are headed in the future.

Edward S. Bennett, OD, MSEd, FAAO

Dr. Bennett is an associate professor of optometry at the University of Missouri-St. Louis and is executive director of the GP Lens Institute. You can reach him at ebennett@umsl.edu.

The ongoing efforts of renowned researcher Nathan Efron, PhD, to indicate that GP lenses will be obsolete by this year could be no farther from the truth. Although this market has not been growing in recent years, there are several specialty designs—notably scleral, multifocal, and corneal reshaping designs—that are growing and should continue to grow in the years ahead. This article will provide a review of recent advances in GP lenses and what is predicted for the GP lens field in the future.

GP Market Trends

Data obtained from Jeff Johnson OD, MBA (vice president, senior research analyst, Robert W. Baird & Co. Inc.), shows that whereas both in the Americas and worldwide there was a slight decrease in revenue generated from GP lenses in 2009 versus 2008, there has actually been a small (4.7 percent) increase in the Americas in the first quarter of 2010 (Table 1). According to David Bland, director of Global Boston GP Business (Bausch + Lomb), whereas single vision spherical GP lenses continue to decline in sales, lenses for presbyopia and for irregular corneas continue to increase (Table 2). As reported by Jason Nichols, OD, MPH, PhD, in the Contact Lenses 2009 annual report that appeared in the January 2010 issue, 9 percent of fits and refits in the United States were into GP lenses with another approximately 1 percent being fit or refit into a hybrid design. This is effectively the same as what he reported for 2008.

Benefits of Today's GP Lenses

I polled the GP Lens Institute Advisory Committee, representing approximately 75 clinicians who have much expertise in GP spherical and special designs, about the benefits of GP contact lenses today. Some of the characteristic responses appear later in this section. It is evident that the vision provided by these lenses for patients who have moderate-to-high astigmatism, irregular corneas, and presbyopia is a major benefit today. In addition, corneal reshaping has demonstrated in preliminary studies an ability to reduce myopia and slow down axial length growth in young people, which can improve their quality of life and represents an exciting area for future growth. It is also apparent that GP contact lenses represent a larger than average segment of contact lens wearers in specialty contact lens practice where these patients are described as more loyal and more profitable to the practice, as well as providing a tremendous referral base.

Following are GPLI Advisory Panel Members' individual responses to the question: "How have GP lenses benefitted your practice and your patients?"

Jack Schaeffer, OD, Birmingham, Ala. "GP lenses have distinguished our practice as a contact lens specialty practice. Patients equate GPs with a higher level of eye care. In a specialized practice setting, GP lenses also provide an advanced visual outcome for most patients and—as we know and research shows—it is one of the safest contact lens modalities."

Christine Sindt, OD, Iowa City, Iowa "My practice is about 50 percent GPs. I work mostly with sick eyes and patients who have a strong desire to see well. Most of my profit comes from GP lenses."

Bruce Anderson, OD, Tampa, Fla. "Working with GP lenses has allowed me to specialize my practice and to create a tremendous referral base for new patients."

Pat Keech, OD, Shoreline, Wash. "My practice is more stable and less subject to economic fluctuations because my patients perceive that we offer services not available at most other practices. We offer our patients almost all contact lens options, not just the run-of-the-mill therapeutic options."

Frank Weinstock, MD, Canton, Ohio "GP lenses fill a need for individuals who require them for specific situations such as corneal irregularities, keratoconus, soft lens intolerance, presbyopia, and cases in which patients are clinically expected to see better with GP lenses."

Jeff Sonsino, OD, Nashville, Tenn. "I could not practice without GPs. We put any patient who has an irregular cornea immediately into GPs. In addition, complex designs, aspherics, standard tricurve, and multifocal lenses add to the options for patients who have any number of conditions."

Susan Resnick, OD, Roslyn, N.Y. "Ours is a specialty contact lens practice in which 20 percent of our patients wear GP lenses. We see a large number of keratoconus patients for whom these lenses are essential."

Brad Giedd, OD, MS, Winter Park, Fla. "GP lenses have helped to provide my patients with clear, crisp vision that they may not have experienced with other options. GP lenses have helped create hundreds of loyal contact lens patients for my practice, many of whom were given an option that they were not previously given elsewhere."

Ray Brill, OD, Mission, Kan. "Patients who have not achieved good vision or biocompatibility with soft hydrophilic lenses can and do achieve success with GP lenses. Also, in the area of overnight corneal reshaping, we can prevent the advancement of myopia and hyperopia with GP lenses. This also offers freedom from wearing a daytime correction and has minimized the risk of unfortunate outcomes from LASIK that would be lifelong."

Jill Beyer, OD, Boston, Mass. "GP lenses are invaluable to my practice. Keratoconus and post-graft patients require them, and multifocal and spherical GPs are an essential part of the practice."

Recent GP Lens Developments

Several major contact lens laboratories have introduced or will soon introduce new designs. We have attempted here to summarize as many as possible:

• ABB-Concise has introduced new designs for managing keratoconus and pellucid marginal degeneration. The company will also soon be introducing a line of semi- and mini-scleral lens designs.

• ABBA Optical has introduced the Advantage Plus Design. This is a poly-aspheric progressive multifocal with a distance center and near periphery. The design is intended for hyperopic patients that are not getting the clarity at near that they need with other types of multifocals/bifocals.

• Accu Lens has added six additional larger lenses, 17.5mm in overall diameter, to its 14-lens Maxim mini-scleral diagnostic lens set.

• Advanced Vision Technologies will be launching a new multifocal lens called Acuity Plus. With its DAC lathing system, the company has fine-tuned this biaspheric multifocal design to include add powers capable of exceeding +3.00D. The design features a mild aspheric posterior surface and a front spherical and aspherical distance, intermediate, and near zone anterior surface.

• Art Optical introduced the Precilens Bi-Expert presbyopic bifocal design in August 2009. Bi-Expert utilizes slab-off technology to produce an equal 360-degree thinner edge shape to promote lens comfort. The inferior inverse construction provides rapid lens stabilization and quick translation of the segment into the pupil on downward gaze. This translating segmented design can be empirically ordered. The company also launched a presbyopic version of the SoClear Corneal/Scleral lens design at the Global Specialty Lens Symposium in January 2010. The 2.0mm center-near zone is multifocal and can be adjusted larger or smaller according to pupil diameter.

• Blanchard Contact Lens has introduced an 18.0mm diameter MSD lens to complement the 15.8mm design. The fitting regimen for both lens designs has been enhanced with the addition of another limbal clearance zone parameter, "Double Increased," as well as new options for axial edge lift control. Blanchard also introduced the RSS lens (Refractive Surgery Specific) multifocal for post-surgical applications with the anterior Reclaim HD lens design. This design helps address the needs of post-refractive surgery patients who now require near vision correction as their presbyopia matures.

• Conforma Contact Lenses continues to explore biaspheric surfaces as a means to minimize spherical aberration and maximize add powers for beginning and moderate presbyopes.

• Contamac US has developed 16mm, 19mm, and 21mm blanks in the Optimum Extra (Dk 100) material, with specialty focus on other diameters as warranted. The company also introduced the Optimum HR 1.51 and Optimum HR 1.53 high-refractive-index materials in 2009.

• Dakota Sciences recently introduced the SoClear Progressive to the SoClear Corneo-Scleral lens design family. It is a fully customizable, near-center aspheric add designed to provide full reading power to all patients in the presbyopic spectrum (Also distributed by Art Optical, as described above).

• Essilor Contact Lenses has introduced the Essilor Perimeter custom large corneal lens for patients who are otherwise GP intolerant. Essilor Contact Lenses (along with Blanchard Contact Lens and Art Optical) has introduced the Precilens Bi-Expert segmented, translating bifocal lens. They have also expanded the Jupiter Scleral lenses to include diameters of 15.0mm, 15.6mm, 16.0mm, 16.6mm, 18.2mm, 18.8mm, and 20.2mm. These lenses also are available in standard peripheral curves along with multiple degrees of reverse and exaggerated regular geometry designs.

• Euclid Systems Corporation has received its first GMP batch of Decorin Core protein, the key ingredient in Stableyez, Euclid's proprietary method of prolonging the visual acuity correction achieved through overnight wear of its Emerald Ortho-K lens. Euclid has made an initial submission to the U.S. Food and Drug Administration for permission to begin human clinical trials with the Decorin Ophthalmic Solution.

• Firestone Optics has introduced front toric, back toric, and bitoric versions of a progressive GP multifocal.

• Lancaster Contact Lenses now incorporates its NV2 Bifocal into its keratoconus (Ni-Cone) and Post PK lenses.

• Lens Dynamics has introduced the Dyna Semi-Scleral large-diameter lens design (13.5mm to 15.0mm overall diameter) for patients who have comfort issues or centration problems. A presbyopic correction within the Dyna Cone Plus and Dyna Intra-Limbal designs is coming soon.

• Lens Mode has reintroduced its Hi Rider GP multifocal. The company claims that this design is unique because patients do not need to be refit while their presbyopia increases. It is available with up to a 4.00D add power.

• Paragon Vision Sciences introduced the CRT SureFit, which provides certified practitioners with a single-use, three-lens-per-eye fitting and dispensing system to lessen initial chair time. This is also available for GP multifocal designs and has been adopted by several laboratories. On the ortho-k front, Paragon CRT Dual Axis allows for modulation of the lens periphery in two meridians when corneal elevation or curvature differences limit the success of a fit. Paragon RG-4, a more traditional, four-curve reverse geometry design for corneal reshaping, is a product extension of CRT. The company also launched a new high-index material—Paragon HDS HI 1.54, which provides the highest refractive index available. The high refractive index, combined with the material's low specific gravity, can provide many potential benefits when prescribed in aspheric GP multifocal lens designs including delivering as much as 1.00D of incremental add power and reducing the overall lens mass in high minus prescriptions.

• TruForm Optics has added front toric, bitoric, and quadrant-specific options to its new 15mm Digi-Form scleral design. The company will also be introducing a junctionless 18mm scleral lens that will also have toric, quadrant-specific, and bifocal options.

• Unilens has introduced the C-Ray GP contact lens featuring ray trace technology. It has an elliptical base curve with the front surface controlled by a distance-center, Power Profile On Eye Ray Trace (patent pending).

• Valley Contax has introduced the CAD Near Multifocal, which is a back-surface aspheric periphery, large-diameter, large-optic multifocal with a front aspheric curve for intermediate and near. They have also introduced the Valley 15 lens, which is a 15.0mm diameter mini-scleral design.

GP Care System Update

Some of the new developments in GP lens care have included the following:

• Advanced Vision Technologies introduced Naturalens RDS (Rinsing, Disinfection & Storage) Multipurpose solution.

• Alcon introduced Opti-Free GP Multi-Purpose solution late last year as an "all in one" product for GP lenses. The product has the same formulation as Unique-pH Multi-Purpose solution and uses the HP-Guar technology to automatically adjust product viscosity in the eye for all-day lens wear comfort. The product also contains the Polyquad preservative, which may be ideal for patients who may be sensitive to PHMB or Chlorhexidine-based preservatives.

• Bausch + Lomb introduced the Boston Advance Comfort Formula Conditioning Solution for use with all types of GP lens materials.

The Future of GP Lenses

I surveyed the GP Lens Institute Advisory Committee to determine where they thought the greatest opportunities for growth are for GP lenses in the next five years. Of the 34 respondents, it was evident that the greatest potential areas pertained to both large-diameter/scleral lens designs and multifocal designs (22 responses each). The third most common response pertained to corneal reshaping (13 responses). Characteristic individual responses to this question appear in Table 3.

Large-Diameter Lenses Based upon the clinician responses, it is evident that this is a huge area for growth. In fact, according to data from David Bland, there has been a fivefold increase in large-diameter lenses from the first quarter of 2006 to the last quarter of 2009, and this trend should continue in the years ahead. These designs have the benefits of initial comfort that rivals or surpasses that of soft lenses as well as providing centration in cases—notably irregular cornea cases—in which other lenses do not center. They have been classified by Sindt (2008) into the following categories:

• Corneo-Scleral: 12.9mm to 13.5mm
• Semi-Scleral: 13.6mm to 14.9mm
• Mini-Scleral: 15.0mm to 18.0mm
• Scleral: 18.1mm to 24+mm

It is evident that many laboratories have introduced or soon will introduce their own scleral designs. For laboratories that already have designs, there has been a trend of adding a second diameter (for example a 15+mm and an 18mm) and possibly some additional options for the midperiphery including a reverse curve.

Multifocal Lens Designs Every laboratory either has its own design(s), distributes designs manufactured elsewhere, or both in many cases. It is evident that many of the most recently introduced designs have an aspheric front surface, which can often minimize potential corneal topography changes induced by a steep aspheric back surface, increase the effective add of the lens, and provide some form of aberration control. With the introduction of the new high-refractive-index materials from Contamac and Paragon, an even higher effective add is possible while providing a lens that has less mass and, therefore, is more likely to exhibit good centration. The introduction of the Bi-Expert lens offers a thinner, segmented translating design that has the advantage—when properly fit—of good vision at distance and near and may be the first translating design that can be empirically ordered.

Looking into the future of presbyopic GP contact lens designs, Fusion LLC, has developed the concept of fitting a GP lens into a soft recess lens carrier called the Pillow Lens. This lens design is an option for patients who require the optics of a GP lens but have difficulty adapting to the comfort of a rigid lens. The hydrophilic portion adds no power component and controls the lens positioning, movement, and the correction for bifocals, bitorics, corneal surface disease, corneal trauma, post-refractive, and keratoconic GP designs. The Recessed Lens System utilizes a hydrophilic base contact lens with integrated anterior recessed geometry that allows for a customized GP contact lens to be placed within the recess carrier (Figure 1).

Figure 1. The Pillow Lens features a recess to hold a custom GP lens.

What Are the Challenges With GP Lenses?

The cost of specialty GP lens designs can represent a hurdle for some patients and eyecare practitioners. Although these lenses can last one to two years or more, they are not available in a frequent replacement or disposable program. This makes it incumbent upon the fabricating laboratory to have, if possible, liberal exchange programs and warranties.

Of course, the most important challenge with GP lenses has been and continues to be initial lens awareness. In a busy practice this can be a significant concern for both patients (who are concerned about the initial sensation) and practitioners (who are worried about both how the patient will respond and how much initial chair time will be necessary). A number of developments are helping to reduce initial awareness including the increasing use of hybrid and large-diameter lenses; technological advancements in manufacturing that have resulted in more consistent lenses with smooth edges and ultrathin profiles; and more wettable materials often further enhanced with a plasma treatment process. There is also promise with new hybrid designs and carrier materials. In addition, it is apparent that large-diameter (often corneoscleral and semi-scleral) GP lenses are increasing in use as a correction for astigmatic patients who have healthy corneas and desire optimum vision.

GP Resources

A number of resources are available for practitioners desiring to increase their knowledge and expertise in GP lenses. The best resources are laboratory consultants. These individuals typically possess a tremendous wealth of knowledge, particularly based upon their experience in assisting on challenging cases including all forms of irregular corneas as well as high astigmatic and presbyopic patients. There is simply no question that they have not heard before, including some of the more routine questions such as "What lens material should I use?"

Material manufacturers such as Bausch + Lomb (www.bausch.com) and Paragon Vision Sciences (www.paragoncrt.com) have online certification courses pertaining to corneal reshaping. Many independent laboratories regularly present webinars to provide dynamic online learning pertaining to new GP designs. Likewise, they often have calculators on their Web site to assist in lens design and ordering.

The National Keratoconus Foundation (www.nkcf.org) offers multiple resources pertaining to keratoconus including several pertaining to coding and reimbursement.

The GP Lens Institute (www.gpli.info) provides webinars; online symposia; educational resources including an online case grand rounds book, multifocal modules, and Microsoft PowerPoint presentations; a Mandell-Moore bitoric calculator; and an online database of designs and materials. In the last quarter of 2010, expect the addition of a four-part narrated PowerPoint series from Dr. Christine Sindt on keratoconus, the "Click N' Fit" program for showing the effect of lens design changes on the lens-to-cornea fitting relationship, and both spherical and toric lens calculators.

Summary

GP lenses will continue to represent an important component of successful contact lens practice today and well into the future. The continuing introduction of innovative large-diameter, reverse geometry, corneal reshaping, and multifocal designs will meet the needs of both young and old patients who desire good quality vision at all distances, comfort, and convenience. CLS

I would like to acknowledge the following members of the GP Lens Advisory Committee: Bruce Anderson, OD; Doug Benoit, OD; Jill Beyer, OD; Ray Brill, OD; Walter Choate, OD; Barry Eiden, OD; Scott Edmonds, OD; Tim Edrington, OD, MS; Brad Giedd, OD, MS; Bob Grohe, OD; Pat Keech, OD; Jon Kendall, OD; John Laurent, OD, PhD; Derek Louie, OD, MS; Marsha Malooley; Robert Maynard, OD; Bruce Morgan, OD; Gary Osias, OD; Catherine Pannebaker, OD, MS; Neal Pence, OD; Roxanna Potter, OD; Miles Press, OD; Phyllis Rakow, FCLSA; Susan Resnick, OD; John Rinehart, OD; Jack Schaeffer, OD; Louise Sclafani, OD; Christine Sindt, OD; Jeff Sonsino, OD; Loretta Szczotka-Flynn, OD, PhD, MS; Ron Watanabe, OD; Frank Weinstock, MD; Eric White, OD; and Joe Yager, OD.