Clinical and Epidemiologic Research Case-Control Pilot Study of Soft Contact Lens Wearers With Corneal Infiltrative Events and Healthy Controls

PURPOSE. The purpose of this study was to assess risk factors associated with soft contact lens (SCL)-related corneal infiltrative events (CIEs). METHODS. This was a single-visit, case-control study conducted at five academic centers in North America. Cases were defined as current SCL wearers with a symptomatic CIE. For each case, three age-and sex-matched controls were enrolled. Subjects completed the Contact Lens Risk Survey (CLRS), a standardized scripted medical interview, supplied a recent health history, and underwent an ocular examination. Microbial culturing of the ocular surface, SCL, and lens storage case was conducted for all cases and one of the three matched controls. Univariate and multivariate logistic regression modeling were used to assess the risk of developing a CIE. RESULTS. Thirty cases and 90 controls 13 to 31 years of age completed the study. Corneal infiltrative event diagnosis included contact lens-associated red eye, infiltrative keratitis, and contact lens peripheral ulcer. Subjects with symptomatic CIEs were more likely to harbor substantial levels of gram-negative bioburden on the ocular surface and contact lens. Significant risk factors for developing a CIE were overnight wear of SCLs, use of multipurpose solution, rinsing SCLs with water, lens storage case older than 6 months, previous ''red eye'' event, use of ocular drops in the past week, and illness during the past week. CONCLUSIONS. This pilot study demonstrated feasibility of enrolling a representative pool of SCL wearers with an untreated, symptomatic CIE and assessing CIE risk factors by using standardized methods. A larger sample size is needed to determine relationships between patient-reported behaviors and exposures, microbial bioburden, and CIE development. Keywords: adverse events, contact lenses, corneal infiltrative events, microbial culturing A recent report from the US Centers for Disease Control and Prevention (CDC) called to light the substantial burden associated with contact lens-related complications. 1 The CDC report estimated that contact lens-related keratitis results in nearly 1 million doctor visits each year and carries an associated cost of $175 million. 1 This estimate does not include the additional ''costs'' to the patient such as pain or discomfort, missed school or work, and potential for permanent loss of vision. Approximately 37 million people in the United States currently wear contact lenses and, due to the increasing prevalence of myopia, more and younger patients are expected to begin wearing contact lenses to aid in its management

IMI – Clinical Management Guidelines Report

Best practice clinical guidelines for myopia control involve an understanding of the epidemiology of myopia, risk factors, visual environment interventions, and optical and pharmacologic treatments, as well as skills to translate the risks and benefits of a given myopia control treatment into lay language for both the patient and their parent or caregiver. This report details evidence-based best practice management of the pre-, stable, and the progressing myope, including risk factor identification, examination, selection of treatment strategies, and guidelines for ongoing management. Practitioner considerations such as informed consent, prescribing off-label treatment, and guides for patient and parent communication are detailed. The future research directions of myopia interventions and treatments are discussed, along with the provision of clinical references, resources, and recommendations for continuing professional education in this growing area of clinical practice

Near visual function measured with a novel tablet application in patients with astigmatism

Clinical relevance: While the clinical focus of performance metrics is traditionally based on visual acuity, research from the field of visual impairment has demonstrated that metrics such as reading speed and critical print size correlate much more strongly with subjective patient reported outcomes and assessed ability in real-world tasks. Background: More recently, digital device use has increasingly replaced many paper-based tasks. Therefore, this study aimed to assess the correlation between standard acuity/contrast metrics and functional reading ability compared to real-world performance on an iPad-based reading task with astigmatic patients corrected wearing toric and mean spherical equivalent contact lenses. Methods: Thirty-four adult participants, with −0.75 to −1.50 D of refractive astigmatism, were enrolled in a double-masked cross-over study and fitted with toric and spherical equivalent contact lenses, in random order. A digital application was developed to assess zoom, contrast modifications, the distance at which the tablet was held, blink rate, and time to complete the reading task. High and low contrast near logMAR visual acuity were measured along with reading performance (critical print size and optimal reading speed). Results: The amount participants chose to increase tablet font size (zoom) was correlated with their high-contrast visual acuity with toric correction (r = 0.434, p = 0.010). With best sphere correction, zoom was associated with reading speed (r = −0.450, p = 0.008) and working distance (r = 0.522, p = 0.002). Text zoom was also associated with horizontal (toric: r = 0.898, p < 0.001; sphere: r = 0.880, p < 0.001) and vertical scrolling (toric: r = 0.857, p < 0.001; sphere: r = 0.846, p < 0.001). There was a significant negative association between the selection of text contrast and zoom (toric: r = −0.417, p = 0.0141; sphere: r = −0.385, p = 0.025). Conclusion: Real-world task performance allows more robust assessment of visual function than standard visual metrics alone. Digital technology offers the opportunity to better understand the impact of different vision correction options on real-world task performance

IMI 2021 Yearly Digest

PURPOSE. The International Myopia Institute (IMI) Yearly Digest highlights new research considered to be of importance since the publication of the first series of IMI white papers. METHODS. A literature search was conducted for articles on myopia between 2019 and mid-2020 to inform definitions and classifications, experimental models, genetics, interventions, clinical trials, and clinical management. Conference abstracts from key meetings in the same period were also considered. RESULTS. One thousand articles on myopia have been published between 2019 and mid-2020. Key advances include the use of the definition of premyopia in studies currently under way to test interventions in myopia, new definitions in the field of pathologicmyopia, the role of new pharmacologic treatments in experimental models such as intraocular pressure-lowering latanoprost, a large meta-analysis of refractive error identifying 336 new genetic loci, new clinical interventions such as the defocus incorporated multisegment spectacles and combination therapy with low-dose atropine and orthokeratology (OK), normative standards in refractive error, the ethical dilemma of a placebo control group when myopia control treatments are established, reporting the physical metric of myopia reduction versus a percentage reduction, comparison of the risk of pediatric OK wear with risk of vision impairment in myopia, the justification of preventing myopic and axial length increase versus quality of life, and future vision loss. CONCLUSIONS. Large amounts of research in myopia have been published since the IMI 2019 white papers were released. The yearly digest serves to highlight the latest research and advances in myopia.Peer reviewe

The Effect of Age, Accommodation and Refractive Error on the Adult Human Eye

Purpose: To quantify changes in ocular dimensions associated with age, refractive error, and accommodative response, in vivo, in 30- to 50-year-old human subjects. Methods: The right eyes of 91 adults were examined using ultrasonography, phakometry, keratometry, pachymetry, interferometry, anterior segment optical coherence tomography, and high resolution magnetic resonance imaging. Accommodation was measured subjectively with a push-up test and objectively using open-field autorefraction. Regression analyses were used to assess differences in ocular parameters with age, refractive error and accommodation. Results: With age, crystalline lens thickness increased (0.03 mm/yr), anterior lens curvature steepened (0.11 mm/yr), anterior chamber depth decreased (0.02 mm/y) and lens equivalent refractive index decreased (0.001 /y) (all p < 0.01). With increasing myopia, there were significant increases in axial length (0.37 mm/D), vitreous chamber depth (0.34 mm/D), vitreous chamber height (0.09 mm/D) and ciliary muscle ring diameter (0.10 mm/D) (all p < 0.05). Increasing myopia was also associated with steepening of both the cornea (0.16 mm/D) and anterior lens surface (0.011 mm/D) (both p < 0.04). With accommodation, the ciliary muscle ring diameter decreased (0.08 mm/D), and the muscle thinned posteriorly (0.008 mm/D), allowing the lens to shorten equatorially (0.07 mm/D) and thicken axially (0.06 mm/D) (all p < 0.03). Conclusions: Refractive error is significantly correlated with not only the axial dimensions, but the anterior equatorial dimension of the adult eye. Further testing and development of accommodating intraocular lenses should account for differences in patients’ preoperative refractive error

Soft toric contact lens wear improves digital performance and vision—A randomised clinical trial

Purpose To compare objective and subjective digital near visual performance and comfort in low to moderate astigmatic participants fitted with toric versus spherical equivalent silicone hydrogel daily disposable contact lenses. Methods This was a double-masked, randomised, crossover study. Participants aged 18 to 39 years with astigmatism of −0.75 to −1.50 D were recruited and fitted with toric and spherical contact lenses, in random order. Outcomes were measured at baseline and after 1 week of wear with each contact lens type after the follow-up visits. High- and low-contrast near logMAR visual acuity, automated visual acuity, zoom (%), contrast (%), reading distance (cm), critical print size (logMAR) and reading speed were assessed. Participants also completed the validated Near Activity Visual Questionnaire (NAVQ) and Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8) for each correction type. Results Twenty-three participants completed the study (74% female, average age 24.4 ± 4.2 years). When participants wore toric contact lenses, near high- and low-contrast visual acuity and automated visual acuity improved by 3–4 letters (all p < 0.03) and participants were able to read faster on an iPad (p = 0.02). Participants were also able to read with 8% less contrast on the iPad with toric lenses (p = 0.01). Participants reported better subjective vision on the overall NAVQ (p = 0.001) and better comfort on the CLDEQ-8 (p = 0.02) with toric lenses. Fewer participants reported difficulty with maintaining focus at near, reading small print, reading labels/instructions, reading the computer display/keyboard and reading post/mail with toric correction. Conclusions Toric contact lenses improve comfort, subjective and objective visual performance with digital devices and other near tasks compared with the spherical equivalent correction in participants with low to moderate astigmatism

Measuring Ciliary Muscle Thickness Changes with Accommodation in Young Adults

Purpose: To develop a measurement protocol for changes in the shape and size of the ciliary muscle with accommodation using the Zeiss Visante™ Anterior Segment Optical Coherence Tomographer (AS-OCT) and to determine the test-retest repeatability of these measurements. Methods: Subjects were 25 adults ages 23–28 years. The ciliary muscle was imaged at two visits with the Visante™ while accommodative response was monitored during imaging using the PowerRefractor. Ciliary muscle thickness was measured at 1 mm (CMT1), 2 mm (CMT2), and 3 mm (CMT3) posterior to the scleral spur and at the point of maximal thickness (CMTMAX). Thickness was measured at these locations while subjects viewed a target at distance and at a 4.00-D accommodative stimulus. Outcome measures were the change in thickness between distance and the 4.00-D stimulus and the change in thickness per diopter of accommodative response (PowerRefractor). Finally, the repeatability measurements between visit 1 and visit 2 were determined with a Bland-Altman analysis. Results: The statistically significant modeled changes in ciliary muscle thickness were as follows: CMTMAX = 69.2 μm (4.00-D stimulus) and 18.1 μm (per diopter of accommodation); CMT1 = 45.2 μm (4.00-D stimulus) and 12.3 μm (per diopter of accommodation); and CMT3 = μ45.9 μm (4.00-D stimulus) and μ12.0 μm (per diopter of accommodation); p < 0.0001 for all. Conclusions: The combination of the Visante™ and the PowerRefractor is a feasible tool for measuring thickening of ciliary muscle at more anterior locations and thinning at more posterior locations during accommodation. We noted a wide range of accommodative responses during the time of image capture in this study indicating that the most accurate estimates of the change in ciliary muscle dimensions with accommodation may be obtained by using accommodative response rather than stimulus values and by using measurements taken simultaneously with image capture

Semi-Automatic Extraction Algorithm for Images of the Ciliary Body

Purpose: To development and evaluate a semi-automatic algorithm for segmentation and morphological assessment of the dimensions of the ciliary muscle in Visante™ Anterior Segment Optical Coherence Tomography images. Methods: Geometric distortions in Visante images analyzed as binary files were assessed by imaging an optical flat and human donor tissue. The appropriate pixel/mm conversion factor to use for air (n = 1) was estimated by imaging calibration spheres. A semi-automatic algorithm was developed to extract the dimensions of the ciliary muscle from Visante images. Measurements were also made manually using Visante software calipers. Interclass correlation coefficients (ICC) and Bland-Altman analyses were used to compare the methods. A multilevel model was fitted to estimate the variance of algorithm measurements that was due to differences within- and between-examiners in scleral spur selection versus biological variability. Results: The optical flat and the human donor tissue were imaged and appeared without geometric distortions in binary file format. Bland-Altman analyses revealed that caliper measurements tended to underestimate ciliary muscle thickness at 3 mm posterior to the scleral spur in subjects with the thickest ciliary muscles (t = 3.6, p < 0.001). The percent variance due to within- or between-examiner differences in scleral spur selection was found to be small (6%) when compared to the variance due to biological difference across subjects (80%). Using the mean of measurements from three images achieved an estimated ICC of 0.85. Conclusions: The semi-automatic algorithm successfully segmented the ciliary muscle for further measurement. Using the algorithm to follow the scleral curvature to locate more posterior measurements is critical to avoid underestimating thickness measurements. This semi-automatic algorithm will allow for repeatable, efficient, and masked ciliary muscle measurements in large datasets

The Effect of Phenylephrine on the Ciliary Muscle and Accommodation

Purpose: To objectively measure changes in the human ciliary muscle dimensions in vivo following instillation of topical phenylephrine, a mydriatic and vasodilating agent. Methods: A cross-sectional study of 25 healthy young adults was conducted. Measurements of pupil size, accommodation, and ciliary muscle thickness were made both before and 30 minutes after instillation of 1% proparacaine and 2.5% phenylephrine. Accommodation was measured three ways: subjectively using a push-up technique and Royal Air Force (RAF) rule, and objectively using both the Grand Seiko autorefractor and PowerRefractor. Images of the temporal ciliary muscle were made using the Visante Anterior Segment Optical Coherence Tomographer (OCT). Ciliary muscle images were objectively analyzed using a computer-based segmentation technique. Results: Amplitude of accommodation with the push-up test was reduced by about 1D with phenylephrine (p 0.30). There was statistically significant thickening of the anterior region and thinning of the posterior region of the ciliary muscle with accommodation (p 0.09). Conclusions: Low-dose phenylephrine does not affect ciliary muscle dimensions, ciliary muscle contractility, or accommodative response to a 4 D near target

IMI - Clinical Management Guidelines Report

Best practice clinical guidelines for myopia control involve an understanding of the epidemiology of myopia, risk factors, visual environment interventions, and optical and pharmacologic treatments, as well as skills to translate the risks and benefits of a given myopia control treatment into lay language for both the patient and their parent or caregiver. This report details evidence-based best practice management of the pre-, stable, and the progressing myope, including risk factor identification, examination, selection of treatment strategies, and guidelines for ongoing management. Practitioner considerations such as informed consent, prescribing off-label treatment, and guides for patient and parent communication are detailed. The future research directions of myopia interventions and treatments are discussed, along with the provision of clinical references, resources, and recommendations for continuing professional education in this growing area of clinical practice