Column
Sclerals: too BIG to fail
Sometimes I cannot believe how far we have come with scleral lenses, how widespread the modality is today and how many people are benefiting from a modality that less than 10 years ago was still such a niche product fitted by just a few experts worldwide. And the development of the modality was hardly backed up by evidence-based research in the beginning, it all stemmed from good clinical insights. Now it is almost the opposite, at least from a peer-reviewed journal point of view. The BIG lenses are very prominent BIG time in the international literature. Just this fall, one of our leading journals in the field, Optometry & Vision Science, hosted a special edition on sclerals. And another leading journal, Contact Lens & Anterior Eye, will host another (unofficial) scleral lens special in December (but the publications are in press already). In the meantime, the November issue of Eye & Contact Lens also hosts a semi-scleral lens special with the bulk of the publications on that topic. To top it off, for a four card straight: the October issue of Contact Lens Update is completely devoted to sclerals. This newsletter tries to the highlights of all of that, but will have to focus on two main areas - scleral lens optics and intraocular pressure measurement in scleral lens wear - as there is simply not enough space to mention everything that is of interest coming out today. More coverage will be featured in upcoming editions of I-site newsletter. Boy, sclerals are surely growing up. While there are some questions remaining, I am still going to pour myself a BIG glass of wine to celebrate the last decade of scleral lenses and everything that it has achieved. Cheers to this great modality and to its future!
Eef van der Worp
Optical
What do we know about scleral lens optics? How do they compare to the optics of other modalities, and what is the impact of manual cleaning? And what are the benefits - and challenges - with wavefront-corrected scleral lenses?
Scleral Lens Optics vs Corneal GPs and Hybrids
In a highly controlled randomized cross-over trial, Levit et al. compared corneal (R)GP and scleral lens performance in the treatment of corneal ectasia, as quoted from the editorial 'the science of sclerals' by Stephen Vincent for Contact Lens & Anterior Eye (in press). Scleral lenses provided superior comfort to corneal (R)GPs but equivalent optical performance. The editorial further refers to a study by Kumar et al. titled 'Do visual performance and optical quality vary across different contact lens correction modalities in keratoconus?' Using a repeated measures experimental approach, they observed that visual and optical outcomes were similar between corneal (R)GPs and sclerals, with both lens types performing superior to a customized soft lens design. However, in advanced keratoconus with a steepest corneal meridian >53D, scleral lenses provided better visual acuity than corneal (R)GPs did, likely due to improved lens stability and centration. The aim of a study by Assadpour et al. from Iran in Optometry & Vision Science was to compare corneal higher-order aberrations (HOAs) between miniscleral and hybrid lenses in keratoconus patients. The root mean square of the total HOAs significantly decreased after fitting both miniscleral and hybrid lens designs. There was a significant change in the third-order vertical coma and spherical aberration after fitting the miniscleral lens. In the hybrid lens group, a significant change was found only in vertical coma after fitting. But the difference in the post-fitting HOA change between the two groups was not statistically significant.
Manual Scleral Lens Cleaning vs. Optical Properties
A study by Sarah Wilting et al. aimed to test whether an equivalent of 12 months of manual cleaning alters the optical and physical properties of conventional and wavefront-guided scleral lenses. Twelve scleral lenses (four identical lenses of three designs) were manufactured in Boston XO material: design A, −5.00D defocus; design B, −5.00D defocus with −0.153-μm vertical coma; and design C, −5.00D defocus with a full custom wavefront-guided correction (second to fifth Zernike radial orders) of an eye with severe keratoconus. One lens of each design group served as a control and was not cleaned. To simulate a year of cleaning, seven individuals cleaned nine lenses (three from each group) twice a day for 27 days using the palm technique and commercially available cleaners, resulting in 378 cleanings of each lens. They found that cleaning over an equivalent 12-month period did not induce clinically significant changes in the optical or base curve properties of conventional or wavefront-guided scleral lenses.
Wavefront-guided Scleral Lenses
A publication by a research team from Houston (USA) - looked at the the consequence of deliberately placing a wavefront-corrected lens at two pre-defined decentered locations. The study aimed at quantifying the performance reduction accompanying the placement of the wavefront-corrected scleral lens at (1) the average decentration location (ADL) observed across individuals wearing scleral lenses and (2) at the geometric center (GC) of the lens. The HOAs increased as expected, and the predicted visual acuity was poorer at both ADL and GC compared with the aligned condition. Thirty-four of 36 eyes had greater residual higher order aberrations at the GC than at the ADL. In clinical terms, 19 of 36 eyes at the ADL and 35 of 36 eyes at the GC had a predicted loss in VA of three letters or greater. In conclusion: placement of the lens at either ADL or GC is predicted to lead to a noticeable reduction in visual acuity for more than half of the eyes studied.
Alignment of Wavefront-guided Lenses
Wavefront-guided scleral lenses improve vision and decrease higher-order aberrations in ectasia and post-surgical corneas. However, for this to be successful, alignment of wavefront-guided scleral lens corrections to the underlying optics of an eye over the effective pupil is crucial. This case demonstrates the necessity of aligning a wavefront-guided scleral lens optical correction to the eye’s effective pupil, defined by the capsulotomy, with misalignments leading to reduced performance.
Optical Considerations for Scleral Lenses
What cannot be overlooked in this overview on scleral lens optics is an excellent review on the very topic by Steve Vincent and Daddi Fadel. The nature of scleral lenses and their typical fitting characteristics mean that many of the assumptions of ‘thin lens’ paraxial optics that are traditionally used for corneal rigid lens calculations may be inappropriate in certain clinical scenarios. The paper provides a comprensive overview of a variety of lens and fitting characteristics that are unique to scleral lenses or that are not typically encountered with corneal rigid lenses. Current front- and back-surface lens designs and future scleral lens applications are also discussed, along with lens modifications to improve visual outcomes and transient changes in corneal optics induced by appropriately fitted modern scleral lenses. Topics such as lens flexure and corneal warpage (under the sceral lens) are surely bonuses, as the paper also discusses how to prevent these as much as possible. Inevitably, lens material characteristics play a major role in both issues. Also, the role of lens decentration on the lens optics, as noted, is covered, as it may induce residual astigmatism and HOAs.
Intraocular Pressure & Sclerals
As reported in the last edition of I-site newsletter, intraocular pressure (IOP) changes in sclerals keep dominating the debate in the field.
IOP Assessment with Different Instruments
Standard IOP measurement with Goldmann applanation tonometry is not feasible during scleral lens wear. The purpose of this study by Jennifer Fogt et al. was to compare assessment of IOP during scleral lens wear using pneumatonometry and transpalpebral tonometry. Mean peripheral IOP measured with pneumatonometry was not significantly different from baseline at any subsequent measurement. Measurements with transpalpebral tonometry were, however, significantly different during scleral lens wear immediately after application and after 1 hour of wear with both lens diameters, but they were not significantly different after either sized lens was removed. In conclusion: assessment of IOP during scleral lens wear varies based upon the instrument used. Although further studies are needed to further elucidate this, clinicians should continue to monitor optic nerve structure and function in scleral lens wearers, the authors report.
Anterior Chamber Angle & IOP Change
Yet another instrument (the Schiotz tonometer) was used in this prospective study involving 20 eyes of 20 subjects. The purpose of this study was to compare scleral IOP and anterior chamber angle (ACA) before, during and after 4 hours of scleral lens wear in healthy neophyte scleral lens wearers from a black African population. The mean scleral IOP before lens wear was 17.2mmHg, which decreased to 16.4mmHg at 4 hours of scleral lens wear and was 16.6mmHg 10 minutes after lens removal. The temporal ACA before scleral lens application was 43.0, and it varied during the 4 hours of scleral lens wear, ultimately increasing to 45.0 at 10 minutes after scleral lens removal. But the changes in IOP and in ACA were not statistically significant, and the authors conclude, therefore, that 4 hours of nonfenestrated scleral lens wear did not have a significant impact on IOP or ACA in most of their study population.
Central Corneal Thickness in Sclerals & IOP
This study looked at the effect of scleral lens Wear on central corneal thickness and intraocular pressure in patients with ocular surface disease. The total average difference in central corneal thickness between before and after scleral lens wear was 7.19μm (544.90±31.29 vs. 552.09±30.30μm), which was a statistically significant increase of about 1%. the increase in central corneal thickness in subjects with ocular surface disease wearing sclerals may be attributed to subclinical hypoxic conditions created by scleral lens wear, the autors state. But they found no significant relationship between scleral lens wear and IOP.
Optic Nerve Head Changes in Sclerals
Twenty-six healthy adults wore a scleral lens on one randomly selected eye for 6 hours, whereas the fellow eye served as a control. Global minimum rim width using optical coherence tomography and IOP measurement using the Icare (Diaton) instrument were used. Minimum rim width thinning was observed in the test and control eyes after 6 hours of scleral lens wear, but the magnitude of thinning was not significantly greater in the lens-wearing eyes. Mean IOP increased +2mmHg in the test eyes, with no change in the control eyes. This study suggests that scleral lenses have a minimal effect on IOP homeostasis in the normal eye during lens wear and an insignificant impact on the optic nerve head morphology in healthy adult eyes.
Bruch-membrane Changes in Scleral Lens Wear
Bruch-membrane opening minimum rim width (BMO-MRW) has been shown to be very sensitive to even minor changes in IOP, with good reproducibility of its measurements. Dan Samaha and Langis Michaud from the University of Montreal (CA) used this the tecnique of BMO-MRW to look at changes during scleral lens wear and found the average diurnal variation for BMO-MRW without lenses to be −4.65 μm after 6 hours, whereas it decreased by 8μm after 6 hours of scleral lens wear. So, scleral lens wear did indeed induce a statistically significant decrease in BMO-MRW that could potentially be attributed to a change in IOP. Although further studies are needed to better understand the significance of the observed changes at the optic nerve head during scleral lens wear, caution seems indicated in patients, and the outlook for a new standard for IOP assessment during scleral lens wear in clinical trials looks promising.
Online Education
GlobalEyes Podcast
Thomas Arnold and Melissa Barnett host a new podcast that provides 'a nexus for eye care practitioners all over the world,' in their own words. Each month, a specialist from a different country will be featured for a lively discussion of the status of the eye care profession in his or her country. In this first episode, Donald Ezekiel, the Australian pioneer of scleral lenses and a true trailblazer in scleral lens development, is interviewed. The podcast is educational in nature, but with a very personal touch and provides interesting personal details. The latest episode features Annelize van Zyl from Pretoria, South Africa, looking at her innovative practice and involvement with the Boston Keratoprosthesis, and sharing her experience with specialty lenses and low vision patients.
I-site is an educational newsletter that is distributed on a monthly basis and provides an update on rigid gas permeable-related topics (scientific research, case reports and other publications worldwide). I-site is objective and non-political. Disclosure: I-site's editor Eef van der Worp, optometrist PhD FAAO FBCLA FIACLE FSLS, receives educational grants from a number of industry partners but is not related to any specific company. Please contact us at: