The effect of lens and fitting characteristics upon scleral lens centration.

PURPOSE: To quantify the impact of varying central fluid reservoir depth, lens thickness/mass and the addition of a peripheral fenestration upon scleral lens centration. METHODS: Ten young, healthy adults participated in a series of repeated-measures experiments involving short-term (90 min) open eye scleral lens wear. Scleral lens parameters (material, back optic zone radius, diameter, back vertex power and landing zone) were controlled across all experiments, and the central fluid reservoir depth (ranging from 144 to 726 µm), lens thickness (ranging from 150 to 1200 µm), lens mass (101-241 mg) and lens design (with or without a single 0.3 mm peripheral fenestration) were altered systematically. Scleral lens decentration was quantified using over-topography maps. RESULTS: On average, scleral lens centration varied by <0.10 mm over 90 min of wear. Medium and high initial fluid reservoir conditions resulted in 0.17 mm more temporal and 0.55 mm more inferior lens decentration, compared to the low fluid reservoir depth (p < 0.001). Changes in lens thickness or the addition of a peripheral fenestration did not cause clinically significant changes in centration (<0.10 mm on average) when controlling for fluid reservoir depth. Central fluid reservoir depth was the best predictor of horizontal and vertical lens decentration, explaining 62-73% of the observed variation, compared to 40-44% for lens thickness and mass. CONCLUSION: Scleral lens decentration remained relatively stable over 90 min of lens wear. A greater initial central fluid reservoir depth resulted in significantly more lens decentration, particularly inferiorly. Large variations in lens thickness, mass or the addition of a single peripheral fenestration did not substantially affect lens centration.

The effect of landing zone toricity on scleral lens fitting characteristics and optics.

PURPOSE: The fit and optical performance of a scleral lens is affected by the alignment of the landing zone with the underlying ocular surface. The aim of this research was to quantify the effect of landing zone toricity upon scleral lens fitting characteristics (rotation and decentration) and optics (lens flexure) during short-term wear. METHODS: Scleral lenses with nominal landing zone toricities of 0, 100, 150 and 200 µm were worn in a randomised order by 10 young healthy participants (mean [SD] 24 [7] years) for 30 min, with other lens parameters held constant. Scleral toricity was quantified using a corneo-scleral profilometer, and lens flexure, rotation, and decentration were quantified using over-topography during lens wear. Repeated measures analyses were conducted as a function of landing zone toricity and residual scleral toricity (the difference between scleral and lens toricity) for eyes with 'low' magnitude scleral toricity (mean: 96 µm) and 'high' magnitude scleral toricity (mean: 319 µm). RESULTS: Toric landing zones significantly reduced lens flexure (by 0.37 [0.21] D, p < 0.05) and lens rotation (by 20 [24]°, p < 0.05) compared with a spherical landing zone. Horizontal and vertical lens decentration did not vary significantly with landing zone toricity. These trends for flexure, rotation, and decentration were also observed for eyes with 'low' and 'high' magnitude scleral toricity as a function of residual scleral toricity. CONCLUSION: Landing zones with 100-200 µm toricity significantly reduced lens flexure (by ~62%) and rotation (by ~77%) but not horizontal or vertical lens decentration, compared with a spherical landing zone, when controlling for other confounding variables. The incorporation of a toric landing zone, even for eyes with lower magnitude scleral toricity (~100 µm), may be beneficial, particularly for front surface optical designs.

George K. Smelser (1908-1973): Atmospheric oxygen and the corneal response to contact lens wear.

Professor George Smelser was a scientist who played a crucial role in advancing the understanding of the anatomical and physiological changes within the cornea during contact lens wear. In a series of unique experiments conducted in the early 1950s, using both humans and animal models, his research team provided the first conclusive evidence that contact lenses impaired the delivery of atmospheric oxygen to the cornea, resulting in an excess of lactate within the cornea and a subsequent ingress of water, leading to corneal oedema and disturbed vision (Sattler's veil). This historical note reviews the career of George Smelser, with particular emphasis on his contributions to understanding the importance of atmospheric oxygen in maintaining corneal homeostasis.

Central and peripheral scleral lens-induced corneal oedema.

PURPOSE: To quantify the magnitude of central and peripheral scleral lens-induced corneal oedema for a range of fluid reservoir thicknesses, and to compare these experimental results with theoretical models of corneal oedema both with and without limbal metabolic support (i.e., the lateral transport of metabolites and the influence of the limbal vasculature). METHODS: Ten young healthy participants wore scleral lenses (KATT™, Capricornia Contact Lenses) fitted with low (mean 141 µm), medium (482 µm) and high (718 µm) central fluid reservoir thickness values across three separate study visits. The scleral lens thickness, fluid reservoir thickness and stromal corneal oedema were measured using optical coherence tomography. Oedema was quantified across the central (0-2.5 mm from the corneal apex) and peripheral (1.25-3 mm from the scleral spur) cornea. Experimental data were compared with published theoretical models of central to peripheral corneal oedema. RESULTS: Stromal oedema varied with fluid reservoir thickness (p < 0.001) for both central and peripheral regions. The mean (standard deviation) stromal oedema was greater for the medium (2.08 (1.21)%) and high (2.22 (1.31)%) fluid reservoir thickness conditions compared to the low condition (1.00 (1.01)%) (p ≤ 0.01). Stromal oedema gradually increased from the corneal centre to the periphery by ~0.3% on average (relative increase of 18%), but the change did not reach statistical significance. This trend of increasing, rather than decreasing, oedema towards the limbus is consistent with theoretical modelling of peripheral oedema without metabolic support from the limbus. CONCLUSIONS: The central and peripheral cornea displayed a similar magnitude of oedema, with increasing levels observed for medium and high fluid reservoir thicknesses. The gradual increase in oedema towards the limbus is consistent with a 'without limbal metabolic support' theoretical model.

Corneal oedema during open-eye fenestrated scleral lens wear.

INTRODUCTION: Studies examining the effect of fenestrating soft and corneal rigid contact lenses upon corneal oedema have yielded conflicting results. Although often utilised in clinical practice, no studies have quantified the effect of fenestrating a scleral contact lens upon corneal oedema. Therefore, the aim of this experiment was to examine the effect of incorporating a single peripheral fenestration on central corneal oedema during short-term open-eye scleral lens wear, while controlling for potential confounding variables. METHODS: Nine participants (mean age 30 years) with normal corneas wore a fenestrated (1 × 0.3 mm limbal fenestration) and non-fenestrated scleral lens (both lenses manufactured using a material Dk of 141 × 10-11  cm3 O2 (cm)/[(sec.)(cm2 )(mmHg)]) under open-eye conditions on separate days. Scleral lens thickness profiles were measured using a high-resolution optical coherence tomographer (OCT). Epithelial, stromal and total central corneal oedema were also measured using the OCT immediately after lens application and following 90 min of wear, prior to lens removal. RESULTS: After adjusting for differences in initial central fluid reservoir thickness and scleral lens thickness between the two lens conditions, the mean (standard error) total corrected central corneal oedema was 0.50 (0.36)% for the fenestrated lens and 0.62 (0.16)% for the non-fenestrated lens. This small difference was not statistically significant (t8  = 2.31, p = 0.81) and represents a 19% relative reduction in central corneal oedema. Similarly, epithelial (t8  = 2.31, p = 0.82) and stromal (t8  = 2.31, p = 0.92) corneal oedema were not significantly different following the fenestrated and non-fenestrated wearing conditions. CONCLUSION: Central corneal oedema in healthy corneas was comparable between fenestrated and non-fenestrated high Dk scleral lenses under short-term open-eye conditions when controlling for lens oxygen transmissibility and initial central fluid reservoir thickness.

Fluid reservoir thickness and aberration relationship in keratoconic eyes with scleral lenses.

PURPOSE: To investigate the effect of varying the fluid reservoir (FR) thickness of scleral lenses (SL) on corrected distance visual acuity (CDVA), contrast sensitivity (CS) and higher-order aberrations (HOAs) in keratoconic eyes. METHODS: Forty eyes with keratoconus were fitted with a diagnostic Boston Sight SL having three different FR thicknesses. CDVA, CS and HOAs were measured before and after 30 min of lens wear. An i-Trace aberrometer and anterior segment optical coherence tomography (AS-OCT) were used to measure HOAs and FR thickness, respectively. RESULTS: Statistically significant improvements in CDVA and CS were seen with different FR thickness lenses (p < 0.01). Baseline CDVA (0.22 ± 0.15) improved to 0.03 ± 0.06, 0.04 ± 0.07 and 0.07 ± 0.08 with low, standard and high FR lenses, respectively. Post-hoc testing showed better CDVA with low (p = 0.006) and standard FR (p = 0.009) lenses compared to high FR lenses. Before lens wear, CS was 1.27 ± 0.27, which improved to 1.67 ± 0.11, 1.73 ± 0.12 and 1.66 ± 0.89 with low, standard and high FR lenses, respectively. Lenses with standard FR showed better CS compared with those having low (p = 0.009) and high FRs (p < 0.001). A statistically significant reduction of higher order-root mean square aberrations (HO-RMS), coma, spherical aberration, secondary astigmatism and trefoil were found with all FR thickness lenses compared to baseline (p < 0.01). No significant difference was noted between lenses (p = 0.01). All three lenses corrected almost equal amount of HOAs. A moderate positive correlation was observed between CDVA and HO-RMS (r = 0.61, p < 0.001) for low FR lenses. CONCLUSIONS: BostonSight SCLERALs were found to be very effective in improving vision, CS and reducing HOAs in keratoconus. Lenses with varying FR thickness showed equal effectiveness in visual performance and reducing HOAs. FR thickness should be considered an important factor to provide better vision and CS by minimising HOAs, as well as to maintain the normal physiology of eyes with keratoconus.

Scleral lens wear following penetrating keratoplasty: changes in corneal curvature and optics.

PURPOSE: Visual rehabilitation following penetrating keratoplasty is the primary indication for approximately 15% of all scleral lens fittings. Since corneal biomechanics are altered following penetrating keratoplasty, the aim of this study was to quantify changes in anterior corneal optics following short-term scleral lens wear in eyes with corneal grafts. METHODS: Scheimpflug images were obtained before and after a period of scleral lens wear (mean 6.3 ± 1.4 h), from eyes that had previously undergone penetrating keratoplasty (10 eyes of nine participants, mean age 31 ± 9 years). Corneal power and thickness data were examined over the central 6 mm, including regional analyses of the central (0-3 mm) and the mid-peripheral cornea (3-6 mm annulus) using customised software to deterime corneal power vectors M (best fit sphere), J0 (90/180 astigmatism) and J45 (45/135 astigmatism). Anterior corneal aberrations were extracted using corneal elevation data. RESULTS: Corneal power vector J45 increased following lens wear (by 0.22 ± 0.05 D, p = 0.003) across the central 6 mm, while M displayed regional variations following lens wear indicating larger changes further from the corneal centre (p = 0.004). The change in corneal power vector M was also correlated with the magnitude of central corneal swelling (r = 0.65, p = 0.04). The anterior corneal aberration terms of oblique astigmatism, hoirzontal coma, and spherical aberration also varied following lens wear (all p ≤ 0.01). The mean change in the corneal spherocylinder derived from the elevation data following lens wear was +0.14/-0.54 × 44 for a 6 mm corneal diameter. CONCLUSIONS: Clinically significant alterations in anterior corneal topography and higher order aberrations were observed following short-term scleral lens wear in eyes that had undergone penetrating keratoplasty. Spherocylindrical changes were approximately double the magnitude and more oblique in orientation compared to previous reports of healthy eyes. Changes in corneal power vector M may be related to epithelial corneal oedema.

Long-term follow-up after scleral lens fixation in patients with Marfan syndrome.

BACKGROUND: The dislocation of the crystalline lens is a common finding in patients with Marfan syndrome (MFS). Scleral intraocular lens (IOL) fixation is an accepted treatment method of this complication. To now, no long-term data on scleral IOL fixation in MFS exist. METHODS: We present a retrospective study of 27 eyes of 17 MFS patients that underwent scleral lens fixation at our clinic between 1999 and 2012. These patients are compared to an age- and surgeon-matched group of 31 eyes of 27 patients who underwent the same procedure for reasons other than MFS. RESULTS: The median age in the MFS group was 35.4 years versus 35.6 years in the non-MFS group. The median follow-up was 4 years for MFS and 3 years for non-MFS. In the MFS group, significantly more IOL-dislocations occurred than compared to the non-MFS group (30% vs. 6.5%, p = 0.02). Retinal detachment occurred in four MFS-eyes compared to three eyes in the non-MFS group. Biometry prediction error was 1.11 diopters (D) for MFS and 1.33 D for non-MFS (p = 0.11). Median BCVA (best-corrected visual acuity, logMAR) was 0.1 in the MFS group versus 0.3 in non-MFS patients. CONCLUSION: Scleral lens fixation in MFS patients achieves satisfying visual and refractive outcomes. Our data shows a significantly higher rate of IOL dislocations in patients with MFS. We therefore recommend addressing this complication preoperatively.

Use of Prosthetic Replacement of the Ocular Surface Ecosystem Scleral Lenses in Patients with Ocular Chronic Graft-versus-Host Disease.

The purpose of this study was to evaluate the impact of prosthetic replacement of the ocular surface ecosystem (BostonSight PROSE, Boston Foundation for Sight, Needham, MA) treatment, utilizing customized scleral devices, on visual acuity, visual function, and ocular surface changes in patients with ocular chronic graft-versus-host disease (cGVHD). A retrospective analysis was performed on 79 eyes of 40 patients with cGVHD referred to the University of Southern California department of ophthalmology between November 2009 and July 2013 for PROSE treatment. This analysis included an assessment of ocular symptoms and visual function before and after treatment using the Ocular Surface Disease Index (OSDI) survey. Pre- and post-treatment visual acuity and clinical data were also compared. Twenty-eight male patients and 12 female patients were included in this study. The average age was 56.1 years (range, 27 to 74). Of the 79 eyes treated, 71 (90%) showed improved visual acuity with PROSE treatment. Fifty-seven eyes (72%) experienced a 2- or greater line visual acuity improvement and 14 eyes (18%) experienced a 1-line improvement. Average logarithm of the minimal angle of resolution improved from .49 ± .52 to .16 ± .44 (P < .0001), which correlates to a Snellen score improvement of approximately 20/60 to 20/30. Sixty-six of 79 eyes (84%) showed decreased corneal staining after treatment. All 9 eyes presenting with filamentary keratitis and 3 eyes with epithelial defects demonstrated complete healing of the epithelial surface after PROSE fitting. At post-treatment follow-up, 8 patients had died and 3 stopped wearing their devices. Of the remaining 29 patients, average OSDI scores improved from 72.6 ± 20.1 to 21.1 ± 14.9 (P < .0001). PROSE therapy, utilizing customized scleral lenses, can reduce ocular symptoms, improve visual acuity, and improve ocular surface integrity or appearance in patients with ocular cGVHD.

Visual quality assessment and comparison of two multifocal scleral lens designs.

PURPOSE: To analyze the visual quality of a new multifocal scleral lens with a customized decentred optic zone compared to a conventional design by measuring visual acuity, contrast sensitivity function, stereopsis, subjective vision and comfort after one month of wear. METHODS: Nineteen presbyopic subjects were fitted with two multifocal scleral lens designs: a conventional multifocal and a customized decentred optical zone design. All subjects wore both scleral lens designs for one month with a two-week washout period. The main variables evaluated included high and low-contrast visual acuity under photopic and mesopic light conditions, binocular defocus curves, contrast sensitivity function and a visual analogue scale (VAS) for subjective vision and comfort. RESULTS: Comparing the two scleral lens designs, statistically significant differences in visual acuity were found, highlighting the improvement in more than one chart line (6 letters) for low contrast near tests under photopic light conditions with the decentred optics lens design. VAS questionnaire scores also showed a significant improvement in distance and overall subjective vision with the decentred optics lenses. Contrast sensitivity function showed an improvement with decentred multifocal lenses at all spatial frequencies measured, being statistically significant for 12 cycles per degree. No differences in stereoacuity were found. CONCLUSION: Multifocal scleral lenses with a customized decentred optical zone proved to be a promising refractive correction in presbyopic subjects after one month of wear, offering good comfort and visual quality under photopic and mesopic light conditions.

Image- and impression-based technology for scleral lens fitting for keratoconus: Efficiency of the fitting process.

PURPOSE: This study describes efficiency of diagnostic, image-based, and impression-based fitting methods by eye care providers who prescribe scleral lenses (SL) for patients with keratoconus. METHODS: An electronic survey was distributed to eye care providers with an interest in SL fitting. Demographic data including practice modality, country of residence, and fitting volume were collected. Efficiency of each fitting method (diagnostic, image, and impression-guided) was queried including time required for initial evaluation, number of lenses ordered, and number of office visits required. Practitioners with access to image and impression-based technology were also asked time required to acquire data and to estimate the percentage of time a lens could be manufactured from the initial images or impressions. RESULTS: 423 practitioners who prescribe SL for patients with keratoconus reported completing a median [IQR] 100 [280] SL fittings. There was no difference in the median time required for initial evaluation (30 min; p = 0.5) or median number of lenses ordered during the fitting process (2 lenses; p = 0.2) between diagnostic, image-based, or impression-based SL fitting methods. Median time to acquire initial images was 10 [7] minutes and 15 [10] minutes to obtain impressions. Images obtained were adequate to order an initial lens 80 [45]% of the time while initial impressions were adequate 90 [40]%. CONCLUSION: In this study, practitioner-reported efficiency of SL fitting was similar between diagnostic, image-based and impression-based methods for patients with keratoconus.

Potential pro-inflammatory impact of scleral lens midday fogging on human corneal epithelial cells: An in vitro study.

PURPOSE: Midday fogging (MDF) occurs when particulate material accumulates in the fluid reservoir (FR) beneath scleral lenses (SL), and its impact on epithelial cells is unknown. This study examines the in vitro pro-inflammatory effect of the FR on human corneal epithelial cells in varying degrees of MDF. METHODS: Normal SL neophytes were recruited to wear SL 8 h daily for 4 days. Following 8 h on days 1 and 4, optical coherence tomography (OCT) images were acquired for MDF quantification using ImageJ, and the FR was collected. FR samples from the same eye were later pooled, diluted 2-fold and applied on human telomerase-immortalized corneal epithelial (hTCEpi) cells cultured on Terasaki microwell plates. Tumor necrosis factor (TNF)-α and culture media were used as positive and negative controls, respectively. After a 30-minute treatment, the nuclear factor-kappa B (NF-κB) pathway was measured by NF-κB-p65 immunofluorescence and images were analyzed with ImageJ. Pearson's correlation was conducted to determine the association between median nuclear fluorescence and MDF. RESULTS: Fourteen FR samples with a mean volume of 22 ± 16 µl were tested. Mean MDF severity following 8 h of SL wear was 25 ± 17 units (range 7 - 64). The median nuclear fluorescence (NF-κB-p65 translocation) in cultured hTCEpi cells ranged from 31.43 to 45.16 while the negative and positive controls were 44.71 ± 1.72 and 108.77 ± 68.38, respectively. Although a potential positive trend between MDF and median nuclear fluorescence was observed, Pearson's correlation analysis revealed no significant association (r = +0.48, P = 0.09). CONCLUSIONS: The results suggest that the FR can trigger NF-κB-p65 translocation in hTCEpi cells, which may be associated with MDF severity. This study introduces the use of Terasaki microwell plates for immunofluorescence studies of the FR. The technique is simple, minimizes sample usage, and does not require expensive instrumentation.

Influence of midday removal and re-application of a scleral lens on fluid reservoir thickness, pre-lens tear film quality and visual acuity.

PURPOSE: To investigate whether the midday removal and re-application of scleral lenses (SL) influences fluid reservoir (FR) thickness, pre-lens tear film quality and visual acuity. METHODS: Two clinical experiments were conducted. A total of 49 keratoconic eyes were evaluated for Part1(tear film and visual acuity analysis) and 12 keratoconic eyes for Part2 (FR thickness analysis). All subjects were wearing 16.4 mm SL for more than 12-months. Tear Film Surface Quality (TFSQ) was evaluated with Medmont E300 at more than 120 min of SL wear, 10 min after SL removal (pre-corneal TFSQ) and 5 min after re-apply the same SL. High and Low Contrast Visual Acuity (HCVA and LCVA) were also assessed with the SL on eye (before and after re-application). For Part2, Anterior OCT (MOptim MOcean4000, China) measurements were taken with and without the SL (at the same time points of Part1) and three outcomes were evaluated: FR thickness, SL thickness (control measurement) and corneal thickness. RESULTS: Removing and re-applying a SL had a statistically significant positive impact on TFSQ, with an improvement from 0.26 ± 011 to 0.16 ± 0.08 (p = 0.001). This was accompanied by a statistically significant improvement in LogMAR HCVA (from 0.10 ± 0.09 to 0.08 ± 0.08, p < 0.001) and LCVA (from 0.39 ± 0.13 to 0.36 ± 0.13, p < 0.001). Regarding Part2 of the study, a statistically significant increase in FR thickness was observed after SL re-application (from 223.64 ± 48.08 µm to 267.81 ± 80.03 µm, p = 0.007). No changes in corneal thickness were observed. CONCLUSIONS: Midday removal and re-application of a scleral lens positively impacted pre-lens tear film surface quality, although the observed improvement in visual acuity does not constitute a clinically significant change. Clinicians should consider that removing and reapplying a scleral lens may result in an overestimation of the fluid reservoir thickness, which could affect clinical assessments and treatment decisions.

Customized Scleral Lenses: An Alternative Tool for Severe Dry Eye Disease-A Case Series.

Purpose: Dry eye disease (DED) is a multifactorial condition significantly impacting patients' quality of life (QoL). This study aims to present a case series highlighting the effectiveness of customized scleral lenses in managing severe DED and improving patient outcomes. Methods: This case series includes three patients with severe DED refractory to conventional treatments. Customized scleral lenses were fitted for each patient, and clinical outcomes were evaluated over a period of two months. Assessments included best-corrected visual acuity (BCVA), slit-lamp examination findings, and corneal National Eye Institute (NEI) scores. Results: All three patients demonstrated significant improvements in BCVA, reductions in ocular symptoms, and enhanced ocular surface health. Patient 1, with secondary Sjögren's syndrome and suspected mucous membrane pemphigoid, showed resolution of conjunctival hyperemia and epithelial defects. Patient 2, with graft versus host disease, exhibited resolution of punctate keratitis and the absence of thread mucus. Patient 3, post-oncologic surgery, achieved complete resolution of keratoconjunctivitis sicca and the restoration of vision. Conclusions: Customized scleral lenses are a useful therapeutic option for severe DED, providing significant symptomatic relief and enhancing patients' quality of life. Their use should be considered in refractory cases to optimize ocular surface health and visual outcomes.

Scleral lens induced short term corneal changes in eyes with Pellucid Marginal Degeneration.

PURPOSE: To investigate the short-term effect of scleral lens (SL) on corneal curvature and corneal oedema in Pellucid Marginal Degeneration (PMD) eyes. METHODS: Corneal anterior, posterior curvature and corneal thickness were measured in 14 eyes of 14 PMD participants with Schiempflug imaging at different corneal diameters and meridians at baseline and after 6 h of SL wear. RESULTS: There was a significant flattening (up to 0.26 mm) of the anterior corneal curvature noted in the inferotemporal quadrant (from 210 to 255 degree at 2 mm, 8 mm and 10 mm corneal diameter), inferonasal quadrant (from 285 to 345 degree at 6 mm and 8 mm corneal diameter), and inferiorly at 2 mm and 10 mm corneal diameter (p < 0.05). Similarly, posterior corneal curvature showed statistically significant steepening mostly in inferotemporal quadrants (from 195 to 255 degree from 4 mm to 8 mm corneal diameter) and inferonasally at 2 mm and 4 mm corneal diameter (p < 0.05). A statistically significant increase in the corneal thickness noted in different corneal diameters with corneal oedema ranging from 2.10 % to 4.00 % after 6 h of SL wear. A gradual increase in corneal oedema was noted form centre to periphery. The baseline central fluid reservoir thickness (FRT) was 341.07 ± 139.8 which reduced to 276.71 ± 114.32 µm after 6 h of lens wear. No significant correlation was noted between corneal oedema with different parameters like initial and final FRT, change in anterior and posterior corneal curvature, and lens thickness (p > 0.05). CONCLUSIONS: Short-term SL wear induced a clinically acceptable range of corneal oedema. A clinically significant flattening in anterior curvature and minimal steepening in posterior curvature were noted. Practitioners should be careful while measuring corneal parameters in PMD eyes wearing SL, as these alterations can provide false impression of disease progression.

Anatomical and physiological considerations in scleral lens wear: Intraocular pressure.

Intraocular pressure (IOP) is maintained through complex and interrelated systems which control aqueous production and drainage, and it has been suggested that scleral lens (SL) wear may disrupt these vital homeostatic processes. This review provides an overview of anatomical and physiological processes that control IOP, identifies potential effects of SLs on these regulatory mechanisms, and examines studies that have attempted to quantify the effect of SLs on IOP. Lack of access to the cornea during SL wear makes accurate assessment of IOP challenging; therefore, a range of different assessment techniques and instruments have been employed to quantify IOP during and following SL wear. Some studies have evaluated IOP using standard techniques prior to lens application and following lens removal, or through a large central fenestration. Other studies have utilised instruments that facilitate assessment of IOP on the peripheral cornea or conjunctiva overlying the sclera (e.g. Schiotz, transpalpebral, and pneumatonometry). Two studies have recently evaluated changes in optic nerve structure during SL wear. Conflicting results have been reported on this topic, much of which examines changes in IOP in healthy subjects over limited periods of time. Currently, only a few studies have reported on long-term effects of SL wear on IOP in habitual SL wearers (after lens removal). Future research in this area must not only consider the fact that ocular conditions treated with SLs may potentially alter corneal biomechanical properties which can influence IOP, but also that these properties may be further altered by SL wear. Monitoring other risk factors for glaucoma (permanent alterations in optic nerve physiology, visual field defects) could provide a more comprehensive assessment of potentially increased risk of glaucomatous optic neuropathy due to SL wear. Ongoing clinical assessment of optic nerve structure and function is advisable in patients at risk for glaucoma who require SLs.

Prospective assessment of corneal biomechanical properties and intraocular pressure after scleral lens wear: A 12-month follow-up study.

PURPOSE: To investigate the long-term influence of scleral lens (SL) wear on corneal biomechanical properties and intraocular pressure (IOP) in irregular and regular corneas. Secondary goal comprised evaluate the fluid reservoir (FR) thickness overtime and correlate it with the changes in corneal biomechanical parameters and IOP. METHODS: Seventy (70) eyes with irregular corneas (IC Group) and 21 eyes with regular corneas (RC Group) were fitted with 16.4 mm SL and wore the lenses for 12 months. Corrected IOP (IOPcc), Goldmann equivalent IOP (IOPg) and corneal biomechanical parameters (Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF)) were measured with Ocular Response Analyzer. Slit lamp images were analyzed with ImageJ software to assess FR thickness overtime. Measurements were taken at lens dispensing visit prior lens wear (LDV1) and after 60 min of lens wear (LDV2) and at 1, 6 and 12-month follow-up visits. Measurements were done immediately after lens removal. RESULTS: There were no statistically significant differences on IOPcc, IOPg, CRF and CH over the follow-up visits in both groups. Mean IOPcc and IOPg fluctuations overtime were clinically insignificant and below 1 mmHg in both groups. IOPg, CH and CRF were significantly lower on IC Group (p < 0.001), although no statistically significant differences were found between groups for IOPcc. Regarding FR thickness, statistically significant differences were found over the follow-up on both groups, with a mean decrease of 186.29 µm on IC Group and 175.32 µm on RC Group (p < 0.001). Statistically significant moderate to high negative correlations between FR and IOPg, CRF and CH were found only in the RC Group. CONCLUSIONS: Long-term SL wear was not associated to changes in corneal biomechanical parameters neither on IOP as measured after lens removal. Besides IOP measurement without SL removal, more studies are needed to investigate the potential relationship with SL fitting characteristics (namely FR thickness).

Use of PROSE for long-term ocular surface support in patients with a permanent keratoprosthesis.

Purpose: To describe the long-term outcome of the use of a specialized scleral lens known as a prosthetic replacement of the ocular surface ecosystem (PROSE) device to support the ocular surface in patients with a Boston Keratoprosthesis (KPro) Type I. All patients in this series were unable to pursue continuous wear of a bandage soft contact lens (BSCL) - a critical aspect of post KPro implantation management intended to protect the corneal carrier tissue from desiccation and stromal melting. Observations: Four eyes of four patients with a Boston KPro Type I were included. All four had failed BSCL wear and were instead treated with PROSE device wear. All four patients had underlying diagnoses associated with a diseased ocular surface (Stevens-Johnson Syndrome [one patient], prior failed penetrating keratoplasty associated with herpes zoster-related neurotrophic keratopathy [one patient], and prior failed penetrating keratoplasty associated with severe dry eye disease [two patients]). Causes of failure of BSCL wear included poor retention, discomfort, and poor vision. PROSE device wear was initiated on average seven and a half (range four to 14) months post-KPro implantation. The wear schedule varied and ranged from waking-hour wear only to 24-h wear. The average duration of device wear was 59.3 (range 28-103) months. Two patients exhibited persistent corneal epithelial defect formation with waking-hour wear, which resolved within 10 days with 24-h device wear. All patients exhibited improvement in vision with PROSE compared to baseline, averaging six and a half (range six to eight) lines of improvement in Snellen acuity, and all patients reported increased comfort. There was no incidence of microbial keratitis, KPro device instability, or other complication throughout the duration of device wear. Conclusions and Importance: This report offers a novel alternate approach to long-term support of the ocular surface in patients with a Boston KPro who fail standard continuous BSCL wear.

Scleral lens prescription and management practices: Emerging consensus.

PURPOSE: To describe international scleral lens prescription and management practices across multiple practice types. METHODS: For this cross-sectional study, scleral lens practitioners were asked to complete an electronic survey that requested information about a single scleral lens patient. Data collected included practitioner demographics (practice type, country, years of experience) and patient indications for scleral lens wear, fitting process, lens design, and care products. RESULTS: Data were collected for 259 patients (419 eyes). Most participants (60%) practiced in the US, 75% worked primarily in community practice, and 58% claimed more than 5 years' experience fitting scleral lenses. Indications for scleral lens wear were corneal irregularity (87%), ocular surface disease (9%), and uncomplicated refractive error (4%). During the fitting process, the mean (SD) number of lenses ordered was 2.4 (1.6) (range, 1-16 lenses) during 3.8 (2.4) visits (range, 1-18 visits). Of patients, 62% used a daily surfactant cleaner, 47% used hydrogen peroxide disinfection, and 67% used single-use vials of nonpreserved saline. Mean lens diameter was 16.2 (1.1) mm (range, 11.8-23.0 mm). The landing zones were spherical (64%), toric (26%), quadrant-specific (7%), and custom (3%) designs. Optical power was spherical in 70%, toric in 27%, and higher-order aberration correcting in 3% of lenses. Only 5 lenses had multifocal optics. CONCLUSIONS: General consensus regarding prescribing patterns (lens design, wearing schedules, care products) between US vs non-US, community vs academic, and new vs established providers is reported in this study. Relatively low percentages of patients wearing lenses with advanced landing zones or optical designs suggest that these new options have not been widely adopted.

Corneoscleral junction angle in healthy eyes assessed objectively.

PURPOSE: To introduce a fully objective method to measure corneoscleral junction (CSJ) angle and evaluate the CSJ angle in healthy eyes. METHODS: Corneoscleral topography (Eye Surface Profiler, ESP) was acquired from the right eye of 105 healthy Caucasian subjects, ranging from 18 to 59 years old. From the raw anterior eye height data, the topographic limbus was automatically demarcated in 360 semi-meridians. Further, in limbal location, the CSJ angle was automatically calculated from corneoscleral height data using neighbouring auxiliary points for angle calculation. Additionally, CSJ angle was statistically analysed regionally. RESULTS: The mean CSJ angle was 177.5 ± 1.1°. There is a mean difference of 7.7 ± 3.7° between the steepest (smallest) and flattest (largest) CSJ angle within the same eye. There exist statistically significant differences between temporal (178.2 ± 1.4°) and nasal (176.4 ± 1.1°) regions (paired t-test, p < 0.001), and between superior (178.1 ± 1.1°) and inferior (177.9 ± 1.1°) regions (p = 0.038). CSJ angle is correlated with limbus position (r = 0.43, p < 0.001). CONCLUSION: CSJ angle is rotationally asymmetric. CSJ varies regionally, being the smallest (steepest) in the nasal region. Significant rough changes in CSJ angle were observed for some healthy individuals.