Overall, it has been a good year for the GP market. According to Nichols (2015, 2016) the percentage of new fits and refits of rigid lenses (including hybrids) increased from 8% in 2014 to 12% in 2015. However, this may be slightly optimistic according to data obtained from Robert W. Baird (Jeff Johnson, OD, CFA, director, senior research analyst), which shows that GP lenses are a $330 million market and declining slightly. There is a mild growth in scleral and overnight orthokeratology (OOK) lenses offset by a decline in corneal GPs. Regardless, GP lenses are still a viable contact lens modality that is showing growth in some areas, notably scleral lenses.
This article reports the results of the second annual GP prescribing survey, which polled Contact Lens Spectrum readers on their prescribing habits with GP spherical and specialty design contact lenses. One hundred and twenty-five eyecare practitioners completed the survey between August and September, 2016. When asked whether they currently fit GP lenses—including hybrids—117 (96.6%) respondents indicated that they do so, which is quite encouraging. When asked what percentage of GP lenses they fit in seven different categories, spherical lenses were highest at 28.9%, but had declined from 43% in 2015; conversely, scleral lenses have increased from 20% to almost 23% during the same time period (Bennett, 2015) (Figure 1).
Figure 1. Approximately what percentage of your GP lenses do you fit in each of the following categories (totaling 100)?
A large group of prominent contact lens specialists and manufacturers were polled as to what, in their opinion, was the greatest advancement in GP lenses this past year and also what they think will be the greatest advancement in 2017. Check out their responses in the sidebars on pages 25 and 26, respectively. You’ll see that scleral lens advancements were predominant, as a greater understanding of scleral shape has resulted in lens designs that can align better with scleral asymmetry, including the introduction of a molded scleral design. The year 2016 also brought the introduction of more sophisticated corneo-scleral topography and the potential to design these lenses empirically.
The most significant event over the last 12 to 15 months was the acquisition by Valeant Pharmaceuticals of Paragon Vision Sciences, resulting in a virtual monopoly of OOK lens designs (via a previous acquisition of Bausch + Lomb). This was followed by Valeant’s departure from the Contact Lens Manufacturer’s Association (CLMA). In the short-term, this led to some products becoming more difficult to obtain, elevated prices for lens designs—notably special design GP lenses—and an uncertain funding outlook for the CLMA’s educational division, the GP Lens Institute (GPLI). However, the CLMA has been successful in working through these unprecedented developments.
This bodes well for the GP industry, as CLMA President Jan Svochak relates: “I am very optimistic in where the GP industry is now. Many CLMA member labs have produced great scleral, irregular cornea, and multifocal lens designs. The reinvestment in the GP industry from the lens design side combined with new manufacturing technology has seen significant improvements in the last couple of years and spurred the growth we are experiencing now. Lens material development has not seen significant advancement for 15 years; however, we expect new GP materials, material suppliers, and surface treatments that should yield purpose-built scleral lens materials in the near future. Education through the GPLI will continue to play a part in helping eyecare practitioners (ECPs) incorporate these new specialty lens modalities.” It remains to be seen whether the companies that departed will rejoin the CLMA and what lasting impact the shake-up will have on the GP market as a whole.
Looking forward, it is apparent that two of the most important advancements that are expected to occur in 2017 will be the approval by the U.S. Food and Drug Administration (FDA) of OOK for myopia control and the introduction of a novel surface coating that has great potential to lessen surface wettability problems.
WHAT DO YOU THINK HAS BEEN THE GREATEST ADVANCEMENT IN GPs IN THE LAST YEAR?
“Advancements in scleral lens designs. Ten years ago, there were two scleral lens designs, spherical in nature, designed from two labs. Today, there are at least 18 manufacturers offering more than 41 different lens designs.”
– Mindy Toabe, OD
“An explosion in scleral lens designs and customization. We now have custom toric peripheral curves, front-surface torics, computer lens designs from scleral topography, sector-specific designs, multifocals, and other customizations, such as edge notching and total scleral lens designs from corneal molds.”
– Bruce Anderson, OD
“Corneo-scleral topography. We are now able to measure the sclera and use fitting software to prescribe customized toric-back-surface scleral lenses that will accurately vault the cornea with the desired pre-selected clearance values.”
– Greg DeNaeyer, OD
“Corneo-scleral profile measurements—and designing of scleral GPs from them—as well as the further development of other custom scleral systems.”
– Barry Eiden, OD
“We have seen a shift toward sclerals for normal corneas. Not only is this product our fastest growing behind sclerals for distorted corneas, but it also is being requested in multifocal designs at the same rate. Additionally, we are seeing an increase in GP multifocals.”
– Troy Miller, AccuLens
“The greatest advancements seem to lie in our ability to measure lens fits on-eye. As an example, one company recently released software that provides a clearance map of the central 6mm of the lens over the cornea. This avoids the manual measurements that we had to make on those same patients just one year ago.”
– Mile Brujic, OD
“The addition of corneal-scleral topography is providing a much better understanding of the scleral shape, rate of scleral toricity occurring, and variation of the amount of scleral toricity in your patients’ eyes.”
– Cassandra Gordon, Visionary Optics
The Scleral Explosion Continues As it has been for the last seven to eight years, the most important advancement in GP lenses in 2016—and one that allows GPs to continue to hold their own in the contact lens industry—is the increasing use of scleral lenses. It is apparent that as more ECPs introduce scleral lenses into their practices and observe the potential life-changing effect on their patients—notably those exhibiting irregular corneas and dry eye—it also encourages other ECPs to pursue this modality. This is reflected in the GP prescribing survey as well.
In responding to the question as to what percentage of their irregular cornea patients were fit into each of six different modalities, scleral lenses were the predominant choice, as the respondents selected scleral lenses for greater than 50% of these patients (Table 1). This was almost 1.5 times the combined total for small-diameter and intralimbal GPs. As small-diameter lenses were the most preferred in the 2015 survey, this is substantial.
|LENS TYPE||≤ 10%||≥ 30%||≥ 50%|
|Scleral lenses||37 respondents||68 respondents||47 respondents|
|Small-diameter GPs||51 respondents||39 respondents||18 respondents|
|Intralimbal GPs||60 respondents||26 respondents||15 respondents|
|Hybrid||66 respondents||14 respondents||6 respondents|
|Custom soft||65 respondents||10 respondents||6 respondents|
|Piggyback||72 respondents||3 respondents||0 respondents|
When asked whether scleral lens use has increased or decreased in their practice, only five respondents indicated that it had decreased, whereas 73 respondents indicated that it had increased; about 25% indicated that their scleral lens use had increased greatly in the past year (Table 2).
|ANSWER CHOICE||RESPONSE %||RESPONSE #|
|Stayed the same||14.4%||18|
The predominant application for scleral lenses remains, of course, fitting irregular cornea patients. There was a sevenfold increase for ECPs fitting ≥ 50% of their irregular cornea patients into sclerals as compared to the second-ranking application, which is fitting individuals who have dry eyes/ocular surface disease (Table 3). It is important to note that 73 (71%) of the respondents fit at least 10% or more of their scleral lenses on dry eye patients. In fact, 30 respondents fit about one-third or more of their scleral lenses to those patients. Likewise, whereas only three respondents fit 50% or more of their scleral lenses on healthy eyes (e.g., astigmatic and presbyopic), 55 respondents did, in fact, fit scleral lenses on healthy eyes.
|ANSWER CHOICE||≤ 10%||≥ 30%||≥ 50%|
|Irregular cornea||95 respondents||85 respondents||74 respondents|
|Dry eye/ocular surface disease||73 respondents||30 respondents||12 respondents|
|Healthy eyes (i.e., astigmatic/presbyopic)||55 respondents||11 respondents||3 respondents|
This is consistent with the Scleral Lenses in Current Ophthalmic Practice Evaluation (SCOPE) Study results in which data from 85,000 scleral lens wearers were analyzed (Schornack, 2016). Of these patients, 74.2% were irregular cornea patients, 16.1% were dry eye patients, and 9.7% were healthy eye patients. One recent evidence-based review by Bavinger et al (2015) also found that scleral lenses are a viable option for severe dry eye while being well tolerated and providing relief of symptoms and improved visual acuity.
And, in another study, Barnett et al (2016) reported on the use of scleral lenses on 48 eyes with a history of penetrating keratoplasty, with 69% of the eyes having previously been fit with another type of contact lens. Very good success was achieved with scleral lenses, with the most common reason for discontinuation (eight eyes) being difficulty with lens handling. It is also important to emphasize that, despite the lens thickness necessary with these lenses—approximately twice as thick as corneal lenses—and the tear lens thickness associated with a well-fit scleral lens, it has recently been found that modern high-Dk mini-scleral lenses do not induce clinically significant corneal edema or hypoxic changes (Vincent et al, 2016).
Reasons for Growth The scleral lens market is poised for continued growth over the next several years. There are a number of reasons for the continuing growth of scleral lenses; three are summarized here (Adams, 2016):
1) Scleral lenses separate the specialty contact lens fitters from the commodity fitters. Eyecare practitioners continue to face more and more challenges to their dispensary due to advancements in online availability and the (recently debated) commoditization of soft lenses. Educated practitioners are adopting day-to-day fitting habits that give them the opportunity to be in control of not only what lenses their patients wear, but where they actually purchase those lenses. Some say that specialty practices are the way of the future for today’s successful practitioners, and scleral lenses will definitely be part of that.
2) Over the past five years, sclerals have seen many dramatic technological advancements. Material manufacturers, lathe manufacturers, and lens designers have all made major investments in their processes that have increased the efficiency and success of sclerals in general.
3) Scleral lenses are socially and medically rewarding. We’ve all heard the stories of the patients who are in tears because they “haven’t seen this well for many years.” This type of situation often ends with hugs and a feel-good moment for all parties involved. What practitioner wouldn’t want to experience that over and over again?
Advancements Recent advancements in scleral lenses have included more sophisticated designs that exhibit greater alignment to scleras that are not uniform in curvature. This includes the use of back-surface-toric haptics—quite beneficial in larger scleral designs (typically ≥16mm), as the sclera tends to exhibit greater asymmetry the further away from the cornea (Morrison, 2016)—and the introduction of a unique custom-molded scleral lens.
In addition, a corneal-scleral topographer that uses a structured light approach for 3D mapping to obtain very precise measurements of the cornea and sclera with a 22mm maximum field of view entered the market this year. This opens the door for successful empirical fitting of scleral lenses, potentially allowing for an optimum initial patient experience with scleral lenses while also reducing chair time.
Additionally, the first filling solution that is cleared for use by the FDA for use with scleral lenses was introduced in 2016. Other solutions should be forthcoming in the next few years.
WHAT DO YOU THINK WILL BE THE GREATEST ADVANCEMENT IN 2017?
”Once [a new polymer surface coating] is introduced in the fall, this will significantly improve the quality of life for our patients who have surface wetting issues. [This new coating] will also be a practice builder for practitioners.”
– Melissa Barnett, OD
“Orthokeratology will have FDA clearance for myopia control, rejuvenating the GP industry for years to come.”
– Jeff Walline, OD, PhD
“The future of custom specialty lenses is bright with the introduction of more sophisticated evaluation systems obtaining more information about the surface of the entire eye well beyond the limbus with different methods and sophisticated instrumentation.”
– Keith Parker, AVT
“There is new machinery and new options for those machines coming in the near future that will assist the manufacturing labs in producing improved edge designs for scleral lenses. It has taken some time to improve and automate some of these processes, but the improvements will be moving into the labs, and hopefully this will enable the labs to control their designs with even more precision and bring more consistent lens fit comfort to the scleral market.”
– Chris Pantle, DAC
“The market for larger-diameter lenses will continue to expand as practitioners explore the numerous conditions that can be treated. New innovations in hybrid technology will help grow the entire segment.”
– Jim Kirchner, OD, SynergEyes
OVERNIGHT ORTHOKERATOLOGY AND CORNEAL RESHAPING
OOK continues to exhibit mild growth according to Jeff Johnson, OD, CFA, director, senior research analyst for Robert W. Baird & Co. Contact Lens Spectrum has also observed this trend in its annual GP Prescribing survey in which 21.6% of the respondents indicated that their use of OOK designs has increased slightly or greatly in the past year (Table 4) as opposed to 20.56% in 2015; in addition, only 2.4% reported a decrease in their OOK use as compared to 7.22% last year.
|ANSWER CHOICE||RESPONSE %||RESPONSE #|
|Stayed the same||14.4%||18|
Every year since the first OOK lens system was cleared by the FDA, there’s been the perception that it could represent a mainstream method of myopia control for young progressive myopes. With the predicted FDA clearance of OOK for myopia control in 2017, this could become a reality. In addition, the increasing use of peripheral plus soft multifocals, complemented by ongoing research to develop improved peripheral plus designs (Sankaridurg et al, 2011; Holden, 2015) should also result in much greater consumer awareness in the next few years.
In fact, when polled about what their myopia control program includes, soft multifocals were the most popular choice (45.6% versus 38.4% for OOK) (Figure 2), literally reversing the numbers from 2015. The mechanism, as reported in several studies—most recently by González-Méijome et al (2015)—adds supporting evidence to the role of the peripheral retina, notably becoming more myopic and slowing eye growth. As for safety, a comprehensive review of the literature by Lin and Xie (2016) supported the previous study by Bullimore et al (2013) in concluding that the risk of microbial keratitis in OOK was similar to that of other overnight modalities. They also concluded that there was sufficient evidence to suggest that OOK is a safe option for myopia correction and control.
Figure 2. What does your myopia program include?
MATERIALS AND LENS DESIGNS
Multifocal Designs This is an area in which new innovations occur every year in the GP industry. Front-surface aspheric designs continue to be predominant and allow for an on-K base curve radius selection as well as the ability to provide a high add and to make empirical fitting the optimum method. In addition, the availability of a progressive multi-add hybrid, an increasing number of scleral multifocal lens designs for healthy and dry eye patients, and reverse geometry designs for post-refractive surgery patients provides a larger tool box for ECPs to fit the increasing and underserved population of presbyopes.
Material Technology Advancements in material technology and lens manufacturing have resulted in ultrathin lens designs with aspheric or pseudo-aspheric peripheries and consistent edges. These developments may be responsible for a reported decreased incidence in corneal desiccation versus that obtained with previous generations of GP lenses (Azhar et al, 2015).
The most anticipated development for 2017, based on a survey of prominent specialty lens fitters, is the likely FDA approval and introduction of a potentially revolutionary surface coating. Hopefully, this polymer coating of GP lens materials, to be offered with all Optimum materials from Contamac, will allow patients to wear lenses comfortably and for a longer duration than previously.
A growing number of resources are available to assist ECPs who are interested in either adding specialty lenses to their practices or gaining greater confidence and proficiency with these designs. This includes hands-on workshops, organizations emphasizing specialty designs, laboratories, and social media.
Hands-On Workshops Numerous laboratories, organizations, and large continuing education meetings have added specialty lens hands-on workshops. They are typically scleral, but some have also included OOK and multifocal programs. These programs represent a great opportunity for ECPs to gain experience and confidence with these designs; look for these types of program to increase in number in 2017. Large meetings—such as the Contact Lens Society of America (Sept. 30 to Oct. 2, 2016 in Lake Buena Vista, FL), the American Academy of Optometry (Nov. 9 to 12, 2016 in Anaheim, CA), the Global Specialty Lens Symposium (Jan. 26 to 29, 2017 in Las Vegas), Vision By Design (Apr. 5 to 9, 2017 in Dallas), and Optometry’s Meeting (Jun. 21 to 25, 2017 in Washington, DC)—offer great hands-on opportunities.
Organizations Several specialty contact lens organizations have numerous programs and resources to benefit ECPs who are interested in increasing their knowledge and confidence with these designs.
• The GPLI (www.gpli.info) continues to provide new resources and programs, including symposia, workshops, and monthly webinars, all of which are archived.
• The Scleral Lens Education Society (SLS; www.sclerallens.org), which has a passionate board of directors and Fellows, continues to increase the number of seminars, hands-on workshops, and webinars pertaining to scleral lenses. The SLS is also working collaboratively with the GPLI on scleral lens symposia and an online scleral lens troubleshooting module.
• The American Academy of Orthokeratology and Myopia Control (AAOMC; www.orthokacademy.com) continues to serve this important and growing modality and provides the largest annual meeting in the United States with its Vision By Design symposium.
• The Contact Lens Society of America (CLSA; www.clsa.info) provides programs including a library of online seminars.
• Finally, a new and very promising organization, the International Keratoconus Academy (IKA; www.keratoconusacademy.com) was recently formed to provide education pertaining specifically to irregular cornea management, including a very useful blog for ECPs to share and discuss cases as well as any questions and/or challenges that they have with these patients.
Laboratories Perhaps the most beneficial resource to any ECP are the laboratories that manufacture GP lenses. The labs often provide many online resources, including webinars, calculators, and fitting and troubleshooting guides and videos for their designs. Their most important resources, however, are their consultants, who often troubleshoot dozens of cases in a single day and typically have the motto that there is no such thing as a stupid question. It is important for ECPs to be proactive in using these invaluable resources. Certainly, the ability for ECPs to use an iPhone adaptor for their biomicroscopes allows them to send photos and video of lens fits to their lab consultants; and, if available, they can also send corneal topography to consultants. This allows for online consultation, which is being increasingly used today.
Social Media The ability to consult with fellow specialty GP fitters is an important advantage of the use of social media. Scleral Lens Fitters on Facebook is an especially useful and popular site.
WHERE DO YOU SEE GPs IN THE YEAR 2020?
“Multifocal options in all GP designs will continue to advance to meet the needs of the aging population. Scleral lens designs may incorporate a sensor in the future, increasing their use as a medical device for monitoring systemic diseases.”
– Mindy Toabe, OD
“I see the possibility of developing applications in corneal cross-linking and GP lenses being used together in molding and reshaping of the cornea.”
– Bruce Anderson, OD
“Near perfect corneal GP fittings based on new topography software and great-fitting scleral lenses from scleral mapping software.”
– Stephanie Woo, OD
“Leading the fight against myopia progression.”
– Clarke Newman, OD
“GPs will continue to play the dominant role in meeting the needs of patients who have irregular corneas and will play an ever growing role in slowing myopia progression via corneal molding.”
– Tom Quinn, OD, MS
“I think that Dr. Sindt’s [custom-molded scleral lens system] will start another revolution with manufacturers and produce better scleral lenses.”
– Bob Maynard, OD
“In 2020, we will have the ability to measure the sclera and produce a scleral lens with exact alignment of the haptic. We are close now, but the technology of linking scleral topography with lens production has remained elusive.”
– Jeff Sonsino, OD
“There will be multifocal contact lens designs that will replace soft contact lenses, especially for astigmatic patients.”
– Jack Schaeffer, OD
“Monitoring blood glucose and IOP, contact lenses that take videos and photos, contact lenses with a chip built in so you can see who is calling on your phone.”
– Roxanne Achong-Coan, OD
WHAT IS THE FUTURE OF GP LENSES?
The future looks promising for GP lenses, notably in the specialty lens categories. To see what industry experts predict will be the role of GP lenses in the year 2020, check out the sidebar on page 30.
It is evident that OOK should exhibit an even greater presence in the future as a result of the expected large increase in consumer awareness about ocular complications associated with high myopia and the existence of contact lens options to reduce this problem.
The future will also see continued growth in the scleral lens segment—perhaps not at the current rate, but with more sophisticated corneo-scleral topography instrumentation complemented by designs that can exhibit very good alignment with the sclera. In addition, with empirical fitting, greater patient success is likely.
One of the questions that should be answered by 2020 is the role that scleral lenses will play with regard to the correction of healthy ametropic eyes. The GP/hybrid multifocal tool box should continue to expand as design advancements in aspheric, hybrid, and scleral multifocals occur.
Of course, it is even possible that specialty GP lenses will be on the leading-edge technologically speaking. For example, some may be available that can monitor glucose or intraocular pressure (IOP); we are already seeing entries in these categories. And, there may be a lens on the horizon that is designed with nanotechnology that will be able to capture everything that wearers see in a day and then transfer that data to a separate portable drive.
One thing is safe to say: GP lenses are not going away anytime soon. What we will continue to see, however, is that spherical corneal GP contact lenses for refractive error correction are gradually being replaced by specialty lens designs for irregular corneas, presbyopes, and myopia control. CLS
Acknowledgements: Roxanne Achong-Coan, OD; Josh Adams (Valley Contax); Mark Allen (Lagado Corp.); Bruce Anderson, OD; Melissa Barnett, OD; Doug Benoit, OD; David Bland (Bausch + Lomb); Mile Brujic, OD; Karen Carrasquillo, OD, PhD; Greg DeNaeyer, OD; Tim Edrington, OD, MS; Barry Eiden, OD; Art Epstein, OD; Cassandra Gordon (Visionary Optics); Steve Harney, OD; Andy Jackson (MidSouth Premier); Derrell James (X-Cel); Dave Kading, OD; Jim Kirchner, OD (SynergEyes); Mike Lipson, OD; Bob Maynard, OD; Langis Michaud, OD; Troy Miller (AccuLens); Clarke Newman, OD; Chris Pantle (DAC); Keith Parker (Advanced Vision Technologies [AVT]); Roxanna Potter, OD; Tom Quinn, OD, MS; Jack Schaeffer, OD; Nick Siviglia (Lancaster Contact Lens); Jeff Sonsino, OD; Jan Svochak (TruForm Optics); Mindy Toabe, OD; Eef van der Worp, BOptom, PhD; Jeff Walline, OD, PhD; Ron Watanabe, OD; Steve Webb (Metro Optics); Frank Weinstock, MD; Stephanie Woo, OD; and LaMar Zigler, OD.
For references, please visit www.clspectrum.com/references and click on document #251.
Dr. Bennett is assistant dean for Student Services and Alumni Relations at the University of Missouri-St. Louis College of Optometry and is executive director of the GP Lens Institute. He is also clinical features editor for Contact Lens Spectrum. You can reach him at email@example.com.