Optical considerations for scleral contact lenses: A review

Scleral contact lenses have a range of therapeutic and optical applications. In recent years, scleral lens prescribing has increased due to significant advances in ocular imaging technology, lens manufacturing processes, and the widespread availability of scleral lenses globally. While the optical principles of scleral lenses are identical to those of corneal rigid lenses (i.e. the post-lens tear layer neutralises the majority of anterior corneal astigmatism and higher order aberrations), the nature of scleral lenses and their typical fitting characteristics means that many of the assumptions of ‘thin lens’ paraxial optics traditionally used for corneal rigid lens calculations may be inappropriate in certain clinical scenarios. This review provides a comprehensive overview of a variety of lens and fitting characteristics that are unique to scleral lenses, or not typically encountered with corneal rigid lenses, and how these factors may potentially influence optical performance based on theoretical modelling, in particular; scleral lens parameters, the post-lens tear layer, and dynamic changes during lens wear. 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.     

Corneal surface wettability and tear film stability before and after scleral lens wear

PurposeThe aim of this study was to evaluate the anterior surface of scleral contact lens and ocular surface wettability before and after one-month of scleral lens wear in patients with keratoconus.MethodsForty-nine patients with keratoconus (36.26 ± 9.03 years) were recruited. The sample was divided into two groups: patients with intrastromal corneal ring (KCICRS group) and patients without ICRS (KC group). TFSQ, Schirmer I test, Ocular Surface Disease Index (OSDI questionnaire), tear break-up time (TBUT) and corneal staining were evaluated in two different visits: Baseline (before lens wear) and one-month visit (10 min after lens removal). Visual Analog Scale (VAS questionnaire) was filled in just after inserting the lenses and just before removing them. TFSQ mean and inferior were evaluated over the contact lens surface at the moment of inserting the lens (baseline visit) and after 8 h of lens wear (one-month visit).ResultsAnterior corneal surface TFSQ values increased in all groups after scleral lens wear (p < 0.05). However, there were no statistical differences found at the moment of inserting or after 8 h of lens wear on previous contact lens surface TFSQ (p > 0.05). No changes were found in tear volume for total and in KC and KCICRS groups (p > 0.05). For all groups, there was a statistical decrease of TBUT (p < 0.05). In addition, OSDI score, corneal staining and VAS score improved after scleral lens wear from baseline in total and in both KC and KCICRS groups (p < 0.05).ConclusionThe scleral contact lens surface keeps its wettability after one-month of wear. However, the wettability of the ocular surface is worse after contact lens wearing.     

Corneal epithelial bullae after short-term wear of small diameter scleral lenses

Complications of scleral lens wear are not well documented or understood. While multiple studies focus on oxygen transmission during scleral lens wear and associated corneal swelling, little is known about the effects of varying scleral lens fitting relationships, especially when there is corneal interaction. Scleral lenses, by convention, are designed to completely clear the corneal surface and rest on the conjunctival and scleral tissue. However, some designs maximize oxygen transmission by reducing the lens diameter, thickness, and recommended corneal clearance.While the modifications increase oxygen transmission in any scleral lens design, they also distribute the lens mass closer to the limbus and make visualization of corneal clearance, especially narrow in the limbal region, more difficult. The sequelae from mechanical interaction between scleral lenses and the ocular surface, in particular the cornea, remain uncertain.This case series will describe corneal epithelial bullae, molding, and epithelial erosions as unintended scleral lens complications. These corneal changes corresponded to areas of contact lens-corneal bearing confirmed utilizing a combined scanning laser ophthalmoscopy (SLO) and anterior segment OCT. This case series will discuss epithelial bullae detection, their etiology, and suggestions for application of this information into scleral lens fitting protocols.     

BCLA CLEAR – Medical use of contact lenses

The medical use of contact lenses is a solution for many complex ocular conditions, including high refractive error, irregular astigmatism, primary and secondary corneal ectasia, disfiguring disease, and ocular surface disease. The development of highly oxygen permeable soft and rigid materials has extended the suitability of contact lenses for such applications. There is consistent evidence that bandage soft contact lenses, particularly silicone hydrogel lenses, improve epithelial healing and reduce pain in persistent epithelial defects, after trauma or surgery, and in corneal dystrophies. Drug delivery applications of contact lens hold promise for improving topical therapy. Modern scleral lens practice has achieved great success for both visual rehabilitation and therapeutic applications, including those requiring retention of a tear reservoir or protection from an adverse environment. This report offers a practical and relevant summary of the current evidence for the medical use of contact lenses for all eye care professionals including optometrists, ophthalmologists, opticians, and orthoptists. Topics covered include indications for use in both acute and chronic conditions, lens selection, patient selection, wear and care regimens, and recommended aftercare schedules. Prevention, presentation, and management of complications of medical use are reviewed.     

BCLA CLEAR - Scleral lenses

Scleral lenses were the first type of contact lens, developed in the late nineteenth century to restore vision and protect the ocular surface. With the advent of rigid corneal lenses in the middle of the twentieth century and soft lenses in the 1970’s, the use of scleral lenses diminished; in recent times there has been a resurgence in their use driven by advances in manufacturing and ocular imaging technology. Scleral lenses are often the only viable form of contact lens wear across a range of clinical indications and can potentially delay the need for corneal surgery. This report provides a brief historical review of scleral lenses and a detailed account of contemporary scleral lens practice including common indications and recommended terminology. Recent research on ocular surface shape is presented, in addition to a comprehensive account of modern scleral lens fitting and on-eye evaluation. A range of optical and physiological challenges associated with scleral lenses are presented, including options for the clinical management of a range of ocular conditions. Future applications which take advantage of the stability of scleral lenses are also discussed. In summary, this report presents evidence-based recommendations to optimise patient outcomes in modern scleral lens practice.     

Patterns of fitting cosmetically tinted contact lenses

Cosmetically tinted soft contact lenses are an attractive option for contact lens wearers. Data that we have gathered from annual contact lens fitting surveys demonstrate that those wearing tinted lenses are more likely to be female (4.6% of all soft lenses fitted vs. 1.6% for males; p < 0.0001) and younger (27 ± 11 years vs. 33 ± 13 years for those wearing non-tinted lenses; p < 0.0001). Tinted lenses tend to be worn more on a part-time basis and are replaced less frequently than non-tinted lenses. The decline in fitting tinted lenses over the past 12 years may be due to (a) the current limited availability of tinted lenses in silicone hydrogel materials and daily disposable replacement frequencies, which together represent a significant majority (78%) of new soft lenses fits today, (b) growing concerns among lens wearers and practitioners relating to the risks of complications associated with the wearing of tinted lenses, and (c) reduced promotion of such lenses by the contact lens industry.     

Performance and predictability of a new large diameter contact lens design in keratoconic corneae

ObjectivesTo evaluate the clinical performance and predictability using corneal topography in the fitting of a new large-diameter rigid gas permeable (RGP) contact lens design in eyes with keratoconus (KCN).MethodsThis study presents a review of eyes fitted with Alexa ES lenses for nonsurgical optimisation of visual correction. Anterior steep simulated keratometry (sim-K steep), corneal diameter (HVID), the Curvature at the apex in diopters (Cc), and distance from the corneal apex to the centre of the cornea (Lc) in millimetres derived from the Cone Location and Magnitude Index (CLMI) were recorded. Visual acuity, mean wearing time, final sagittal depth and adverse events were also recorded. Correlations between topographic indices and base curve were evaluated using the Pearson correlation coefficient.ResultsForty-six eyes from 26 patients (19 males/ 7 females) were included. Mean visual acuity improved from 0.49 ± 0.32 with glasses, to -0.02 ± 0.10 with the contact lens. The mean daily wear time was 12.19 ± 1.96 hours. No complications were detected in 95.65% of the eyes [95% CI (83.9%-99.2%)] but two episodes of non-infectious keratitis. The average sagittal depth of the lenses fitted was 0.425 ± 0.15 mm, and it was positively correlated with the Cc value (r² = 0.66, p< 0.0001, n=46) derived from the CLMI index of the pre-fitting topography.ConclusionsCorneoscleral RGP contact lenses are a safe, and effective alternative for managing KCN patients to corneal lenses. Also, clinical data derived from the corneal topography could be used to help to decide the first diagnostic lens to be assessed, easing the overall fitting process.     

Contact lens wear by Royal Air Force aircrew in World War II

PurposeTo provide an overview of the use of contact lenses by RAF aircrew in World War II by identifying some of the fitters and wearers and appraising the clinical results that they achieved.MethodsA wide-ranging literature search was undertaken that encompassed peer-reviewed journals, non-refereed publications, books, official publications, newspapers and archived documents.ResultsThirty-one aircrew are known to have worn sealed scleral lenses in order to meet the required visual standards. Of these, only two were considered to be completely unsuccessful, one of whom was unilaterally aphakic. One additional case of undisclosed contact lens wear was found and the identity of this officer was established. Brief biographies of a few pilots establish the context of their contact lens wear.ConclusionOverall, the results of scleral lens wear were variable reflecting those achieved by civilian patients of the period. While three men complained of discomfort due to heat and glare, one pilot experienced no photophobia when flying above white clouds in brilliant sunshine and another found no difficulty caused by altitude or tropical climate. Wearing time ranged from about 2 h to 16, or more, hours. In about a third of the cases, wearing time was limited due to the onset of a form of contact lens induced-epithelial oedema known as Sattler's veil and effective solutions to this problem were not implemented until after the war.     

The therapeutic and optical application of a rigid gas permeable semi-limbal diameter contact lens

Purpose

To evaluate the therapeutic and optical application of a semi-limbal diameter (S-LIM) rigid gas permeable (RGP) contact lens.

Method

A retrospective non-comparative case series of 14 consecutive patients (22 eyes) who were referred to one senior optometrist for the fitting of S-LIM contact lenses at Moorfields Eye Hospital. The cases comprised of 11 patients (17 eyes) with keratoconus, 1 patient (2 eyes) post-surgical ectasia from previous LASIK, 1 (1 eye) post-graft patient, and 1 patient (2 eyes) who required corneal protection secondary to lagophthalmos. These patients had failed previously with other lens designs because of lens intolerance, unstable vision, chronic 3 and 9 o’clock corneal staining, and inadequate corneal protection for the patient with lagophthalmos. A conventional method of using diagnostic lenses with fluorescein assessment was adopted in fitting the S-LIM lenses.

Results

The median duration of problems encountered with previous lenses was 4 years (range 0.5-10 years). The median visual acuity with the S-LIM lens was 6/9 (range 6/5-6/24). A median of 1 diagnostic lens (range 1-3 lenses) was required to achieve a satisfactory fit. At the last recorded follow-up, 10 patients (14 eyes) had no clinically observable problem and were wearing their lenses with a median wearing time of 8 h per day (range 1-18 h). The median duration of follow up was 6 months (range 2-18 months). One patient (1 eye) abandoned lens wear because of satisfactory unaided vision.

Conclusion

The use of a semi-limbal diameter lens can be an effective modality in patients with intolerance to other lens designs. However, lens modification from the standard design and the use of ocula lubricants are often required to optimise lens fit and to enhance tolerance.     

A one-year prospective study on scleral lens wear success

PurposeTo report the success rate of scleral lens wear and the lens handling learning curve from the wearers perspective.MethodsNinety-five participants were consecutively screened for enrollment in a prospective study. Participants were divided into two groups: ICGroup (71 participants with irregular corneas) and RCGroup (24 participants with regular corneas). Participants attended several visits: Baseline, Lens Dispense Visit (LDV), 1-month, 3-month, 6-month and 12-month follow-ups. The number and causes of scleral lens discontinuation and the time to correctly apply the lens for the first time at the LDV were evaluated. During follow-ups, participants answered a questionnaire regarding scleral lens wear (mean number of hours/day and days/week of lens wear, methods used for handling, number of attempts to correctly apply and remove the lenses).ResultsSixty-nine participants (73 %) successfully completed the 12-month period. Twenty-six participants (27 %) discontinued scleral lens wear. None of the discontinuations were due to adverse events. The success rate (number of participants that wore the lenses for the 12 months) was 77 % in ICGroup and 58 % in RCGroup. The main reasons for scleral lens discontinuation were handling issues (35 %) and discomfort (19 %). 36 % of participants required <15 min to correctly apply the lens at the LDV, however 13 % required >60 min (participants that wore spectacles, soft lenses or had no correction method at Baseline). The mean wearing time (hours/day and days/week) increased significantly from 1-month to 12-month appointments: from 9.8–11.1 h and 5.1–5.6 days in new scleral lens wearers, while the number of attempts to correctly apply and remove the lenses decreased significantly.ConclusionsThe success rate was 73 % during this prospective 12-month follow-up study. The main reasons for drop-out were handling issues and discomfort. Participants who continued scleral lens demonstrated increased handling skills.     

Corneal epithelial thickness and corneal curvature changes during the day: The effects of daily disposable contact lens wear

PurposeTo evaluate the changes in corneal epithelial thickness and corneal anterior and posterior curvatures during the day, and the effect of wearing daily disposable soft contact lenses.MethodsThirty-two healthy volunteers were enrolled in a randomized crossover study. At the baseline visit, corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany) were performed in the morning and in the afternoon (8 hours after). Then, each subject was fitted with the following brands of daily disposable contact lenses in random order: Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue Oneday (Nesofilcon A) on different days. All fitted lenses had a power of −3.00 diopters (D). Measurements were repeated before putting the contact lens on and after an-eight-hour contact lens wear.ResultsWith no lens wear, the anterior topographic indices showed significant steepening [Kflat: p < 0.0001; Ksteep: p < 0.0001 and maximum keratometry value (Kmax): p = 0.04] and the corneal thickness significantly decreased in the central and temporal portion of the cornea in the afternoon. There were no significant changes in the posterior topographical indices and corneal epithelial thickness. With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05). There was no statistically significant difference in the epithelial thickness among the groups wearing different contact lens types (p > 0.05).ConclusionsAnterior corneal topographic indices steepen depending on the natural diurnal variations. Daily wear of soft contact lenses appears to mask this steepening. The corneal epithelial thickness is not affected by daily disposable soft contact lenses.     

Central-to-peripheral corneal edema during wear of embedded-component contact lenses

PurposeWith active investigation underway for embedded-circuit contact lenses, safe oxygen supply of these novel lenses remains a question. Central-to-peripheral corneal edema for healthy eyes during wear of soft contact (SCL) and scleral lenses (SL) with embedding components is assessed.MethodsVarious 2-dimensional (2D) designs of SL and SCL with embedded components are constructed on Comsol Multiphysics 5.5. Local corneal swelling associated with the designed lenses is determined by a recently developed 2D metabolic-swelling model. Settled central post-lens tear-film thicknesses (PoLTFs) are set at 400 μm and 3 μm for SL and SCL designs, respectively. Each lens design has an axisymmetric central and an axisymmetric peripheral embedment. Oxygen permeability (Dk) of the lens and the embedments ranges from 0 to 200 Barrer. Dimensions and location of the embedments are varied to assess optimal-design configurations to minimize central-to-peripheral corneal edema.ResultsBy adjusting oxygen Dk of the central embedment, the peripheral embedment, or the lens matrix polymer, corneal swelling is reduced by up to 2.5 %, 1.5 %, or 1.4 % of the baseline corneal thickness, respectively, while keeping all other parameters constant. A decrease in PoLTF thickness from 400 μm to 3 μm decreases corneal edema by up to 1.8 % of the baseline corneal thickness. Shifting the peripheral embedment farther out towards the periphery and towards the anterior lens surface reduces peak edema by up to 1.3 % and 0.6 % of the baseline corneal thickness, respectively.ConclusionsTo minimize central-to-peripheral corneal edema, embedments should be placed anteriorly and far into the periphery to allow maximal limbal metabolic support and oxygen transport in the polar direction (i.e., the θ-direction in spherical coordinates). High-oxygen transmissibility for all components and thinner PoLTF thickness are recommended to minimize corneal edema. Depending on design specifications, less than 1 % swelling over the entire cornea is achievable even with oxygen-impermeable embedments.     

The short-term effect of contact lens wear on blink characteristics

PurposeThe aim of this pilot study was to investigate the initial effect of contact lens wear on spontaneous blink characteristics.MethodsThis was a randomised, crossover pilot study. Spontaneous blinking was recorded using a high-speed infrared camera in ten subjects with three different soft contact lenses (spherical hydrogel, spherical silicone hydrogel and toric hydrogel), one rigid contact lens and without contact lenses. Custom semi-automated software was used to determine palpebral aperture height, interblink interval (IBI), blink speed, blink completeness and blink duration.ResultsThe IBI was significantly greater for non-lens wear compared with the silicone hydrogel [ratio (95% CI): 1.34 (1.16, 1.55), p < 0.0001], toric hydrogel [1.28 (1.10, 1.48), p = 0.0001] and rigid corneal lenses [1.48 (1.27, 1.73), p < 0.0001]. The spherical silicone hydrogel lens showed greater closing-phase speed than non-lens wear [mean difference (95% CI): 27.4 (5.6, 49.1) mm/s, p = 0.006]. Shorter total blink duration was found for non-lens wear compared with any of the lens types [spherical hydrogel: ratio 0.89 (0.81, 0.98), p = 0.01; spherical silicone hydrogel: 0.87 (0.80, 0.95), p = 0.0001; toric hydrogel: 0.90 (0.83, 0.98), p = 0.004; and rigid corneal: 0.88 (0.82, 0.96), p = 0.0004]. Opening-phase speed (p = 0.12) and blink completeness metrics (all p > 0.5) were not influenced by wearing condition.ConclusionThis work showed that short-term contact lens wear influenced the palpebral aperture height, IBI, speed and duration of the blink, and the effect is dependent on the contact lens type. The completeness of the blink was not altered by contact lens wear. Future work should be conducted to assess the effect of long-term wear of different contact lens types on blink characteristics. The measurement of spontaneous blinking characteristics represents an immediate, sensitive and non-invasive evaluation of the impact of a contact lens on the ocular surface.     

The treatment of ocular hypotony after trabeculectomy with a scleral lens: A case series

PurposeOcular hypotony after trabeculectomy may be treated medically, surgically and with a tamponade. Three cases are reported in which a scleral lens was applied to treat ocular hypotony after mitomycin C (MMC) augmented trabeculectomy.MethodsIn this retrospective case series the records of three eyes of three patients who developed ocular hypotony after they had undergone trabeculectomy augmented with MMC were evaluated. The patients were between 11 and 69 years of age and the intraocular pressure (IOP) after surgery ranged between 3 and 6 mmHg. All three patients showed a negative Seidel test; one had suspected hypotonic maculopathy and one had a collapsed anterior chamber. After unsuccessful treatment with large bandage lenses all three patients were subsequently fitted with a scleral lens. The scleral lens was fitted to fully cover and compress the bleb. Scleral lenses were worn continuously with a check-up after one night of wear and subsequent check-ups when needed. One patient continued to wear the scleral lens for a further 6.5 months on a daily wear basis.ResultsIn all three eyes the IOP was higher after wearing the scleral lens. Two patients stopped wearing the scleral lens after the IOP was stable. One patient developed a cataract; the cataract surgery was combined with a bleb revision and scleral lens wear was therefore discontinued.DiscussionThe scleral lens might be a useful tool in the treatment of ocular hypotony after trabeculectomy augmented MMC surgery. The effect of the scleral lens on the ocular pressure is unpredictable. Caution is advised in vulnerable corneas due to risk factors such as hypoxia and infection. Further research is warranted to establish the safety of the procedure, the patient selection and the overall success in a larger patient group.     

Intraocular pressure changes in neophyte scleral lens wearers: A prospective study

PurposeTo examine the variation in intraocular pressure (IOP) during the first six months of scleral lens wear.MethodsThirty-two neophyte scleral lens wearers were recruited and IOP was measured using Goldman applanation tonometry before, and after 1 and 6 months of scleral lens wear (following lens removal). All scleral lenses were designed based on scleral topography or an impression of the ocular surface. Central corneal thickness and the central post-lens fluid reservoir thickness were quantified using optical coherence tomography.ResultsPost-lens removal IOP displayed an increasing trend after 1 and 6 months of lens wear, but the magnitude of change was not clinically or statistically significant using several repeated measures analyses to account for sporadic missing longitudinal data (mean increase of 1 mmHg or less, p > 0.05). Central corneal thickness and the central post-lens fluid reservoir remained stable throughout the first six months of lens wear.ConclusionIOP measured following lens removal did not vary significantly during the first 6 months of lens wear in scleral lens neophytes. Further research is required to determine if IOP varies during lens wear, following lens removal, or after longer-term lens wear due to suction forces or tissue compression beneath the landing zone.     

Intraepithelial corneal haemorrhage in a rigid contact lens wearer

Intracorneal haemorrhage is a rare complication of modern contact lens wear. While a limited number of reports have described intracorneal haemorrhages (typically stromal) associated with the extended wear of soft contact lenses with limited oxygen permeability for the correction of aphakia, this case report documents the management and resolution of a significant intraepithelial corneal haemorrhage associated with long-term rigid contact lens wear for keratoconus and high myopia.     

Review of 20 years of soft contact lens wearer ocular physiology data

BackgroundSince the introduction of Silicone hydrogel (SiHy) contact lenses 20 years ago, industry has continued to modify lens materials, designs, lens care products and manufacturing processes, striving to improve contact lens physiological performance, comfort, and convenience for wearers. The purpose of this study was to investigate whether the ocular health of habitual soft contact lens wearers today is better than it was in previous decades.MethodsBaseline ocular physiology data for 3624 participants from a The Brien Holden Vision Institute clinical trials database were retrospectively reviewed. Records were grouped into 3 time periods; A: >2 decades ago (1997–1999), B: one decade ago (2009–2014) and C: recent years (since 2015). Physiology data for both neophytes and habitual contact lens wearers included; bulbar, limbal and upper palpebral conjunctival redness, corneal and conjunctival staining and conjunctival indentation from contact lenses.ResultsCorneal staining levels are similar between neophytes and contact lens wearers at time points A and C but worse for contact lens wearers at time point B. Limbal redness was greater in contact lens wearers than in neophytes at time point A but at time points B and C they are not different to the non-contact lens wearing population. In recent years, most ocular physiological variables in habitual contact lens wearers are similar to neophytes.ConclusionsWhile there have been changes over the past two decades in ocular physiological responses to contact lens wear, it appears that ocular health with current day contact lens wear is similar to no lens wear in most respects.