THE GP AND CUSTOM SOFT MARKETS continue to change, notably with an ongoing series of innovations in these specialty designs that can often be life-changing to the wearer. As with previous annual reports, much of the information in this article was obtained by polling the Contact Lens Spectrum (CLS) readership and other experts in the field and exploring recent research.
As we have done in previous years, we asked the GP Lens Institute (GPLI) Advisory Board what they believed to be the most important developments in GP and custom soft lenses in the past year. Once again, these popular innovations pertain primarily to scleral lenses and myopia management. Their top four responses (in order) are: wavefront-guided technology/higher-order aberration (HOA) correction, other technological advancements with scleral lenses, myopia management, and custom soft lenses. Additional representative quotes are provided in Appendix 1.
MYOPIA MANAGEMENT
Myopia management is becoming an increasingly important component of an eyecare practice as it grows toward its deserved role as a standard of care for young people. When the CLS readers who treat myopia were was surveyed about the role of myopia management in their practices, almost all indicated that it has stayed the same or increased, with the latter predominating.
When asked what myopia management options they employ in practice, soft multifocals continue to be the most preferred (58%) but low-dose atropine has increased from approximately 32% one year ago1 to 45% this year (Figure 1).
Soft Multifocals The increasing use of soft multifocals is the result of several benefits that they possess. They can easily be incorporated into an eyecare practice. The Bifocal Lenses in Nearsighted Kids 2 (BLINK2) study has found that there is no rebound effect after lens discontinuation.2 Soft multifocals were shown to be highly successful over a six-year period, offering vision quality comparable to that of a single soft lens and garnering high ratings for subjective vision, minimal glare-related issues, and significant myopia control.3
It was also found that six years of dual focus myopia control delayed the time to reach the final growth level by almost four years.4 In addition, novel designs continue to be introduced, promising great potential for providing myopia control with satisfactory vision performance.5
Orthokeratology. The effectiveness of orthokeratology (ortho-k) in slowing myopia progression continues to be validated. In a recent publication, data were pooled from three prospective studies, all of which evaluated the use of ortho-k for slowing myopia progression in children compared to single-vision spectacle lens wear over a two-year period.6 Ortho-k was found to be very effective in slowing myopia progression in 40% of the wearers and not particularly effective in 25%. When compared to 0.01% atropine, ortho-k achieved a similar efficacy in slowing myopia progression, and both were significantly more effective than single-vision spectacles.7
In addition, the quality of life of ortho-k-wearing young people was found to be significantly higher than that of spectacle wearers, with fewer than 10% reporting difficulty falling asleep, itchy/burning/dry eyes, or foreign body sensation after lens application.8 The safety of ortho-k continues to be validated as well.9
Of course, corneal topography is essential in fitting and monitoring ortho-k patients, and topography-driven software-based designs exhibit great potential.10
In the field of lens design, research continues to confirm that the smaller the optical zone/treatment zone diameter, the greater the effect on slowing both axial length and myopia progression.11,12 Likewise, if the lens is decentered on the eye, this results in slowing axial elongation.13 While practitioners should not intentionally decenter the lens, it is recommended that they make every effort to get the plus power closer to that area.
Comparison Studies The effects of three myopia control lenses—defocus-based soft lenses, spectacles with highly aspherical lenslets, and ortho-k—on vision and vision-related quality of life were compared.14-16 The soft lenses resulted in the poorest central contract sensitivity; poor peripheral vision performance resulted from spectacle wear; and ortho-k was recommended for children who had specific demands for motion perception or global scene recognition.
The soft lens wearers scored significantly higher than the spectacle wearers in five of the seven scales: vision, appearance, activities, peer perception, and overall. The 54 participants wearing soft lenses scored significantly higher than the 56 participants wearing single-vision spectacles for the same five scales. These five categories, in addition to satisfaction, were all rated higher than spectacle wearers in the ortho-k group.
In a one-year study, defocus incorporated multiple segments (DIMS) spectacle wearers were compared to both ortho-k and single-vision spectacle wearers.17 Both DIMS and ortho-k wearers resulted in significant retardation of axial elongation. Ortho-k was also more effective than DIMS lenses for patients who have higher levels of myopia.
GP LENSES
The most recent data indicate that 11% of lenses fit in the U.S.18 and 10% internationally19 are GP lenses. In a recent report on international trends in GP prescribing from 2000 to 2023, GP prescribing slightly increased from 2000 (14.2%) to 2023 (15.2%).20
The report also detailed how the types of designs prescribed have changed. Spherical lenses represented 55% of rigid lens fits between 2007 and 2011, whereas ortho-k and scleral lenses represented only 11.5% and < 9%, respectively. Shifting to between 2019 and 2023, spherical lenses comprised 30% of rigid lens fits, whereas scleral lenses and myopia control/ortho-k lenses represented 28% and 21% of rigid lens fits, respectively.
The CLS readership was surveyed as to what percentage of GP lenses they prescribed in several different categories (Figure 2). Another trend is the shift toward empirical fitting in most types of GP lens designs (Table 1). This represents both the necessity of providing good quality of vision upon initial application and the advances in technology in both ocular surface evaluation and lens manufacturing.
Lens Materials There is a very apparent trend in which GP materials are used most: high-/hyper-Dk materials are predominant. Internationally, it has been reported recently that for corneal GPs, high-Dk (> 90) comprise 65.1% of the lenses used, as opposed to mid-Dk (40 to 90) at 31.3% and low-Dk (< 40) at 3.6%.19 Likewise, GP rigid lenses fitted with high-Dk materials increased from 36% between 2007 and 2011 to 67% between 2019 and 2023.20
A recent (2024) survey conducted by the Contact Lens Manufacturers Association (CLMA) of 113 contact lens fitters who were all members of the GP Lens Institute also demonstrated a very strong preference (72.6%) for high-Dk (defined as 101 to 160), versus 40 to 100 Dk (15%), and > 161 Dk at 12.4%.21
Sclerals Any previous statements or perceptions that scleral lenses have plateaued or are decreasing are most certainly not based on fact. The trend toward increasing use is quite evident20 as more eyecare professionals (ECPs) incorporate them into practice and embrace their potential life-changing benefits, notably for irregular cornea and moderate-severe dry eye patients. The CLS readership survey confirms this as well; the majority of respondents indicated that scleral lens use is increasing in their practices (Figure 3).
Likewise, each year the percentage of ECPs responding to the survey who utilize profilometry to fit scleral lenses increases (25% in 2024 versus 17% in 2023).1 In addition, whereas a preference for the use of quadrant-specific haptics has been essentially the same as it was last year for those respondents fitting scleral lenses, the incorporation of toric haptics is becoming the rule rather than the exception as 60.5% use this design in, at minimum, half of their scleral lenses as compared to 48% in 2023.1
The impact of scleral lenses on HOAs, notably in keratoconus, continues to be an area of great interest and strides are being made with wavefront-guided lens technology. The day may arrive relatively soon when the performance of wavefront aberrometry on every scleral lens will become mainstream. Certainly, this procedure can confirm whether HOAs are significant and, therefore, will impact quality of vision and necessitate an HOA-correcting lens. Su and colleagues22 have found that, although only approximately 50% of HOAs are reduced with wavefront-guided lenses used in his practice for irregular cornea patients, this results in one or more lines in visual acuity improvement.
Scleral lens-induced complications also represent an ongoing area of interest in research. The solution to midday fogging is complicated because simply making one change in solution or lens properties will have an impact.23
The Consortium of Researchers Investigating Sclerals (CoRIS) is a large-scale study investigating the incidence of microbial keratitis and other adverse events among scleral lens wearers.The results of this study will be of interest to all scleral lens-fitting ECPs.
Keratoconus The results of the CLS readership survey about prescribing habits for the contact lens correction of the irregular cornea are shown in Table 2. The two most surprising findings pertain to scleral and custom soft lenses. Scleral lenses have been the “go-to” lenses for many years. However, this year, of the six categories, the highest percentage (80%) of respondents fit sclerals and almost 75% fit, at minimum, one in five of their irregular cornea patients into this modality.
In the past, the second most common go-to lens was small-diameter GP. This year, a higher percentage of respondents fit, at minimum, 50% of their irregular cornea patients into custom soft (13%) versus small-diameter GPs (8%).
GP lenses have frequently been found to improve the quality of vision more significantly than other corrective options. This was found once again in a recent study, especially if the prescription was made with a small difference in eccentricity.24 Of course, scleral lenses have been invaluable in the correction of keratoconus and, most recently, have had good success in the correction of HOAs while improving both corrected distance visual acuity and contrast sensitivity in designs of varying eccentricities.25
Multifocals The readership survey, as in past years, showed that aspheric multifocal lenses are far and away the most popular GP multifocal design (Table 3). Certainly, a very appealing benefit—although not limited to this design—is the ability to fit them empirically, which typically results in a very good initial visual experience. As scleral lens wearers become increasingly presbyopic, it wouldn’t be surprising to see an increase in this modality.
In a comparison study, scleral multifocals resulted in better intermediate and near vision without compromising distance vision when compared with a monofocal design.26 As scleral lenses tend to decenter slightly inferior-temporal, decentering the optics to compensate for this has also resulted in improved quality of vision.27 Likewise, the introduction of scleral multifocal designs that rely on profilometry help to ensure a very good lens-eye fitting relationship.28
In the hybrid category, a newer design has been available for a few years and exhibits good promise.28 It is designed with a linear profile lens skirt to improve comfort and minimize a tight-fitting relationship. It can be ordered empirically, is available in three add powers, and, unlike zonal bifocal, aspheric, or diffractive multifocal designs, it has a continuously changing non-monotonic and aperiodic power profile.
Resources The most important resource continues to be the specialty lens laboratory and consultant. The aforementioned CLMA survey found that ECPs averaged 2.27 calls per week to their laboratory consultants.21 As consultants can benefit from topographies and photos and/or video, this question was asked of our readership and the majority (55.2%) indicated they send one or more of these test results to the lab.
CUSTOM SOFT LENSES
Custom soft lenses have been found to be most beneficial for patients who have the following three conditions: 1) high refractive errors (i.e., regular astigmatism, myopia, and hyperopia); 2) irregular astigmatism; and 3) unique corneal size (large or small) or shape (flat or steep).29 Tinted lenses to assist in cosmesis, photophobia, and color discrimination, among other applications, are a limited use but very important application of custom soft lenses.
The applications and success of custom soft lenses continue to increase due to expansion of lens parameters, typically via lathe-cut manufacturing, design innovations, and technological advancements in evaluating the ocular surface. In the latter category, even healthy eyes showed a wide range of sagittal heights.30 Therefore, not only may one-size-fits-all not be an appropriate strategy for spherical soft lenses, but using only corneal information for custom soft lenses should also be questioned.30
Soft toric lens designs, replacement schedules, and material options also continue to expand. Improvements in lens quality, oxygen transmissibility, and edge designs keep improving as well.31 In the readership survey, when responding to what their contact lens prescribing habits are with patients exhibiting ≥ 2D of refractive cylinder, as in past years, standard soft torics prevailed as the go-to option. However, custom soft torics increased from 22.9% to 30%, and both spherical and toric GP lenses decreased as the preferred option (Table 4).
Advances will also help the presbyopic patient. Custom soft lenses are available in higher add powers, higher spherical and cylindrical powers, a wider range of cylinder axes, and center-distance and center-near designs. This not only allows more patients to be fit with this corrective option but also optimizes distance, near, and intermediate vision. More recently, the option exists to offset the optics to better align with the patient’s visual axis.32 In the readership survey, custom soft multifocals vaulted past standard soft multifocals for the first time, with almost one in three utilizing this modality as their go-to lens (Table 5).
The technological advancements allowing ECPs to utilize peripheral corneal and scleral curvature and shape information lends itself very well to fitting custom soft lenses for some irregular astigmatic patients. The availability of essentially any spherical and cylinder power at any axis, complemented by a lathe-cut silicone hydrogel material—important due to the center thickness mandated in these lenses—makes this an increasingly important tool in the contact lens management of the irregular cornea. For post-refractive surgery patients who have oblate corneas, the availability of a reverse-geometry lens design is a welcome addition.33
THE FUTURE
The GPLI Advisory Board was surveyed about the most important developments in GP and/or custom soft lenses in the next 12 months. Not surprisingly, continued development in myopia management designs, increased use of profilometry—notably with scleral design and empirical fitting—introduction of HOA-correcting designs, and increased artificial intelligence (AI) applications were most emphasized (see full responses in Appendix 2).
It is evident that AI applications in the contact lens world will greatly increase in this decade. According to Kading,34AI has the potential to make advances that will take the quality of vision to an entirely new level. It could revolutionize myopia management, as well as scleral and corneal GP lens design. It has already been reported that AI-assisted prescriptions were very beneficial in ortho-k fitting, as the number of trials required to determine the final prescription significantly decreased with this system.35
Thinking a little further ahead, what are some potentially exciting advances in custom soft lenses? The technology exists to create custom molds for a hyper-Dk material that also may accomplish HOA correction in irregular astigmatic patients.36 Likewise, a 778 Dk fully molded silicone elastomer material for these patients is possible.36 Of course, we are all awaiting the introduction of additional drug-delivery lenses as smart lenses and health monitoring lenses, as well as the incorporation of electronics and the use of visual displays.
SUMMARY
The specialty contact lens world is very exciting in 2024, and the future is even more exciting. Corneal GP lenses, with their applications in myopia management, the irregular cornea, high astigmatism, and presbyopia, are here to stay. Scleral lenses have not plateaued but continue to benefit from advancements in technology, resulting in a greater patient base for these designs. The use of custom soft lenses is expanding, as advancements in both regular and irregular astigmatic, presbyopic, and cosmetic correction are being paired with their increasing application in myopia management.
Acknowledgements: Roxanne Achong-Coan, OD; Mile Brujic, OD; Mark Bullimore, MCOptom, PhD; Karen Carrasquillo, OD, PhD; Deepa Chandrasekaran, MS, OD; Gloria Chiu, OD; Brian Chou, OD; Robert Davis, OD; Greg DeNaeyer, OD; Rob Ensley, OD; Jennifer Fogt, OD; Melanie Frogozo, OD; Dan Fuller, OD; John Gelles, OD; Alan Glazier, OD; Bob Grohe, OD; David Kading, OD; Elise Kramer, OD; Michael Lipson, OD; Ken Maller, OD; Marsha Malooley, OD; Heidi Miller, OD; Madison Moss, OD; Chantelle Mundy, OD; Clarke Newman, OD; Pam Satjawatcharaphong, OD; Jack Schaeffer, OD; Moshe Schwartz, OD; Joe Shovlin, OD; Chris Smiley, OD; Jeff Sonsino, OD; Loretta Szczotka-Flynn, OD, PhD; Eef van der Worp, PhD; Maria Walker, OD, PhD; and Jeff Walline OD, PhD.
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