Scoping review: Reporting characteristics for the safety of contact lenses in the pediatric population.

SIGNIFICANCE: Contact lenses are an increasingly popular option for correcting pediatric refractive error due to increased awareness of interventions to slow myopia progression. With limited information on the safety profiles of contact lenses in children, it is important to characterize the current understanding and promote this device's safe and effective use. PURPOSE: This scoping review evaluates characteristics of the current literature that have examined the safety of contact lenses in pediatric patients. It provides future directions for systematic reviews and identifies any gaps in the current literature or areas for future research. METHODS: Literature searches in MEDLINE via PubMed, EMBASE, The Cochrane Library, trial registries, and U.S. Food and Drug Administration clinical trial documentation were performed. Included studies (i.e., experimental and quasi-experimental studies; observational studies including prospective and retrospective cohort, case-control, and analytical cross-sectional studies, and case series of 30 or more participants) reported safety and/or complications of the use of any contact lens for correcting refractive error in children (0 to 18 years). Two independent reviewers first screened the titles and abstracts, and then full-text reports for eligibility. Conflicts in eligibility were resolved by discussions with a third reviewer. Two independent reviewers extracted data, including details about the participants, context, study methods, and key findings relevant to the review question. RESULTS: This scoping review included 73 studies from 10 countries using different contact lens modalities, primarily orthokeratology and soft contact lenses, in children (6 to 18 years). The most common adverse event reported by the studies was corneal staining (60% orthokeratology, 45% soft contact lens). CONCLUSIONS: The need for uniform reporting standards for adverse events poses challenges for comprehensive data synthesis. However, this scoping review identified a sufficient number of studies for a future systematic review to quantify the risks associated with orthokeratology and soft contact lens use in children.

Compounded 0.01% Atropine-What's in the Bottle?

OBJECTIVE: To describe the labeling, packaging practices, and characteristics of compounded 0.01% ophthalmic atropine. METHODS: A convenience sample of parents of children who had previously been prescribed low-concentration atropine for myopia management were randomized to obtain 0.01% atropine ophthalmic solution from one of nine compounding pharmacies. The products were analyzed for various important quality attributes. The main outcomes were labeling practices, concentration of atropine and degradant product tropic acid, pH, osmolarity, viscosity, and excipients in 0.01% atropine samples obtained from nine US compounding pharmacies. RESULTS: Twenty-four samples from nine pharmacies were analyzed. The median bottle size was 10 mL (range 3.5-15 mL), and eight of nine pharmacies used clear plastic bottles. Storage recommendations varied and were evenly split between refrigeration (33%), room temperature (33%), and cool, dark, dry location (33%). Beyond use dates ranged from 7 to 175 days (median, 91 days). Median pH of samples was 7.1 (range, 5.5-7.8). Median measured concentration relative to the prescribed concentration was 93.3% (70.4%-104.1%). One quarter of samples were under the 90% minimum target concentration of 0.01%. CONCLUSIONS: An inconsistent and wide variety of formulation and labeling practices exist for compounding 0.01% atropine prescribed to slow pediatric myopia progression.

Retrospective review of the effectiveness of orthokeratology versus soft peripheral defocus contact lenses for myopia management in an academic setting.

PURPOSE: To evaluate the relative efficacy of peripheral defocus contact lenses (PDCLs) and orthokeratology (OK) in a real-world clinical population, and compare these results with previous randomised controlled clinical trials. METHODS: Records from a university practice were reviewed to identify children who were treated with OK or PDCLs. The analysed sample contained 273 visits from 77 patients. Annualised rates of axial length (AL) progression were calculated and used as the response variable in both linear mixed-effects (LME) and nonlinear regression models. RESULTS: On average, children were 10.7 years of age at baseline (p = 0.14 between treatments), and most patients were female. More Asian children wore OK lenses compared with PDCLs (p < 0.01). At baseline, children had ~3.00 D of myopia and 0.75 D of astigmatism in both treatment groups (p > 0.20 between treatments). LME regression models using only baseline covariates showed no evidence that the annualised change in AL differed between treatments, with or without the inclusion of age, race, sex, baseline AL or spherical equivalent refractive error. Across all possible subsets of models, age at baseline was the best predictor of annualised AL change. There was no statistical difference between parameters of an exponential decay model fitted within treatment using follow-up age as a time-varying predictor, indicating that the rate of annualised change in AL was similar for OK and PDCL. CONCLUSIONS: Retrospective analysis of real-world clinical data found no difference in annualised AL growth between PDCL and OK. Importantly, the AL progression from this clinical setting is consistent with that reported in randomised clinical trials. Therefore, continued research of real-world performance is warranted to understand the safety and efficacy of modern myopia control treatments in the broader population.

Clinical Outcomes of a Randomized Trial with Contact Lenses for Astigmatic Myopia Management.

SIGNIFICANCE: There are limited treatment options for myopia management of patients with moderate to high astigmatism. This work directly compares toric orthokeratology and soft toric multifocal lenses to show differences in visual acuity and patient satisfaction that could impact clinical care. Toric orthokeratology caused reduced visual acuity but was preferred subjectively for vision and overall. PURPOSE: This study aimed to quantify objective and subjective clinical differences between toric orthokeratology and soft toric multifocal contact lenses in the same cohort of myopic wearers with moderate to high astigmatism. METHODS: Thirty adults with refractive myopia (plano to -5.00 D) and astigmatism (1.25 to 3.50 D) were fitted empirically with both toric orthokeratology and soft toric multifocal contact lenses. Participants wore lenses for 10 days in random order, separated by a 14-day washout period. High-contrast visual acuity, low-contrast visual acuity, and glare logMAR visual acuity were measured. Surveys ascertained subject preference for comfort, vision, handling, and cost. Friedman, Wilcoxon signed rank, and χ2 tests were performed. RESULTS: A subset of participants (n = 17) who achieved good vision with both lens types was analyzed. High-contrast and glare acuity with toric orthokeratology were reduced by one line compared with soft toric multifocal lenses (both 0.00 vs. -0.10, P ≤ .003). Participants preferred toric orthokeratology for vision ( P ≤ .03) but soft toric multifocal lenses for handling ( P ≤ .006). When forced to choose between lens types, participants preferred toric orthokeratology for vision and overall (both P ≤ .007). CONCLUSIONS: Participants who achieved good vision with both lens types preferred toric orthokeratology over soft toric multifocal lenses, despite reduced high-contrast and glare visual acuity. Further research is needed to understand the relationship between visual performance and patient satisfaction.

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.

Compounding of Low-Concentration Atropine for Myopia Control.

OBJECTIVES: Low-concentration atropine is commonly prescribed to slow myopia progression in children but is not Food and Drug Administration-approved for that indication and is only available in the United States from compounding pharmacies. The purpose of this study was to ascertain its reported compounding and labeling in the United States. METHODS: US compounding pharmacies were identified through a survey of eye doctors, social media, conferences, and web search. Twenty-eight pharmacies were identified and contacted through telephone and asked a standard set of questions about their methods to compound and label low-concentration atropine. RESULTS: Twenty-six pharmacies across 19 states provided responses, with 21 answering all nine items (81%) and a mean of 8.7 of nine responses. The most frequently reported bottle size was 5 mL (interquartile range [IQR]: 3.5-10). For storage, 10 pharmacies (38%) recommended refrigeration and 16 (62%) stated room temperature was sufficient. The median beyond-use date provided was 65 days (IQR: 45-158). For preparation, 12 pharmacies (50%) used commercially available 1% solution, 9 (38%) used powdered atropine, 2 (8%) used both, and 1 (4%) stated their approach was proprietary. For the added excipients, 11 (42%) used artificial tears only, 6 (23%) added 0.9% saline only, 7 (27%) used more than one ingredient, and 2 (8%) were proprietary. Only two pharmacies mentioned adding boric acid and two mentioned "pH-adjusted" saline. CONCLUSIONS: There were a wide variety of formulation methods in the United States, which may affect atropine stability and potency. Similarly, there are a wide variety of storage and beyond-use recommendations. Further research is needed to assess how these variations may affect the efficacy and safety of low-concentration atropine and of myopia control.

Peripheral Refraction With Toric Orthokeratology and Soft Toric Multifocal Contact Lenses in Myopic Astigmatic Eyes.

Purpose: There has been little research on myopia management options for patients with astigmatism. This study quantified changes in peripheral refraction induced by toric orthokeratology (TOK) and soft toric multifocal (STM) contact lenses. Methods: Thirty adults with refractive error of plano to -5.00 D (sphere) and -1.25 to -3.50 D (cylinder) were enrolled. Cycloplegic autorefraction was measured centrally, ±20 degrees, and ±30 degrees from the line of sight nasally (N) and temporally (T) on the retina. Measurements were made at baseline, after 10 ± 2 days of TOK wear (without lenses on eye), and after 10 ± 2 days of STM wear (with lenses on the eyes) and compared with repeated-measures analysis of variance. Results: Compared to baseline, TOK induced a myopic shift in defocus (M) at all locations (all P < 0.01), but STM only induced a myopic shift at 20 T in both eyes and 30 N/T in the left eye (all P < 0.01). TOK resulted in more myopic defocus than STM at all locations (all P < 0.05) except 20 T in the left eye. TOK induced more J0 astigmatism at all locations (all P < 0.02), except 20 N in the right eye; J0 with STM was different than baseline at 20 N in both eyes and 30 N in the right eye (all P < 0.02). TOK induced more J0 astigmatism than STM at all locations (all P < 0.01), except 20 T in the left eye. Differences in J45 astigmatism, when significant, were clinically small. Conclusions: Greater amounts of peripheral myopic defocus and J0 astigmatism were induced by TOK compared to STM, which may influence efficacy for myopia management.

A comparison of subjective and objective conjunctival hyperaemia grading with AOS® Anterior software.

CLINICAL RELEVANCE: This study evaluates a commercially available conjunctival hyperaemia grading system, providing validation of an important tool for ocular surface research and clinical trials. BACKGROUND: Bulbar conjunctival hyperaemia is a sign of ocular surface inflammation, and proper measurement is essential to clinical care and trials. The aim of this study was to assess the validity and repeatability of an objective grading system in comparison with subjective grading. METHODS: This study was a retrospective, randomised analysis of 300 bulbar conjunctival images that were collected at an academic institution. The images used were de-identified and collected from the Keratograph K5 and Haag-Streit slitlamp. Six investigators graded the images with either a 0.1 or 0.5 unit scaling using a 0-4 Efron grading scale. Three of the investigators also imported the images into the AOS ® Anterior software and graded them objectively. All measurement techniques were assessed for repeatability and comparability to each other. RESULTS: Mean hyperaemia with the objective system (1.1 ± 0.7) was significantly less than the subjective grading (2.0 ± 0.8) (P < 0.001). Both inter- and intra-subject repeatability of the objective system (0.15) was better than the subjective methods (1.70). CONCLUSION: The results showed excellent repeatability of the AOS ® Anterior objective conjunctival hyperaemia grading software, although they were not found to be interchangeable with subjective scores. This system has value in monitoring levels of hyperaemia in contact lens wearers and patients in clinical care and research trials.

Greater higher order aberrations induced by toric orthokeratology versus soft toric multifocal contact lens wear.

PURPOSE: Spherical orthokeratology and soft multifocal contact lenses are commonly used for myopia control and correction, but have been shown to increase spherical aberration, coma and total higher order root mean square (HORMS) aberrations. There are limited myopia control contact lens options for patients with moderate to high astigmatism. The purpose of this study was to quantify changes in higher order aberrations (HOA) in myopic astigmatic eyes fitted with toric orthokeratology (TOK) and soft toric multifocal (STM) contact lenses. METHODS: Ocular wavefront aberrations were measured in both eyes of 30 adult subjects and are reported through the 6th radial order over a 5 mm, dilated pupil. All eyes met refractive criteria of myopia (-5.00 D to plano) and cylinder (-3.50 to -1.25 D). Three measurements were taken at baseline and after 10 ± 2 days of lens wear (TOK, STM). Sixteen subjects achieved logMAR high contrast visual acuity of 0.30 or better in both eyes and were included in this analysis. Repeated measures analysis of variance and post-hoc paired t-tests were used, as appropriate, with Benjamini-Hochberg correction. RESULTS: Higher order root mean square, spherical aberration (C12), and coma RMS (C7, C8) increased with TOK (0.641 [0.222], 0.409 [0.157], 0.426 [0.187] µm, respectively) and STM (0.481 [0.107], 0.223 [0.139], 0.320 [0.130] µm, respectively) from baseline (all p < 0.001). TOK was elevated compared to STM for HORMS (p = 0.03), spherical aberration (p = 0.001) and coma RMS (p = 0.04). CONCLUSIONS: Toric orthokeratology induced more HORMS, spherical aberration and coma RMS than STM in myopic astigmats; however, both lens types showed an increase in HOA compared to baseline, which placed patients outside the age and pupil size matched normative ranges. While the optical changes that accompany these modalities are helpful for myopia management, the induction of HOAs may have unintended consequences on visual performance.

CLEAR - Contact lens optics.

The most fundamental aspect of a contact lens is its optics; the manner in which the refraction of light is managed to optimise vision to the clinical benefit of the lens wearer. This report presents contemporary information on the optical structure of the eye and the optical models employed to understand the correction of refractive error. The design, measurement and clinical assessment of spherical, aspheric, toric, multifocal and myopia control contact lenses are described. The complexity and variety of multifocal lenses is recognised and detailed information is provided for alternating, simultaneous, diffractive, annular, aspheric and extended depth of field lens designs. In terms of clinical assessment, a contemporary review is provided for the measurement of: visual acuity, contrast sensitivity, through focus curves, reading performance, peripheral refraction, toric displacement realignment and patient reported outcomes. Overall, the paper aims to serve as a resource for the prescribing clinician, who can optimise contact lens corrections for patients by building on the optical rationale of these devices; and also highlights future opportunities for research innovation.

Corneal Elevation, Power, and Astigmatism to Assess Toric Orthokeratology Lenses in Moderate-to-High Astigmats.

OBJECTIVES: Fitting philosophies for toric orthokeratology are based on elevation or corneal astigmatism, but it is unclear which is more effective. The purpose of this analysis was to further understand corneal shape and the relationship between peripheral elevation and central astigmatism in moderate-to-high astigmats. METHODS: Corneal tomography was measured three times on the right eyes of 25 moderate-to-high refractive myopic astigmatic adults. Corneal astigmatism and elevation were calculated at 4-, 6-, and 8-mm chords. Subjects were fitted with toric orthokeratology lenses following the manufacturer's guidelines based on elevation. Twenty subjects completed 10 days of wear. A masked examiner assessed movement and centration via slitlamp videos and quantified treatment zone and decentration from tangential power difference tomography maps. Correlations between variables were assessed. RESULTS: Average corneal astigmatism was 2.20±0.70 DC and peripheral elevation was 50.88±18.92 µm and they were strongly correlated (4 mm R2=0.96, 6 mm R2=0.92, 8 mm R2=0.86, all P<0.001). Each diopter of astigmatism equated to 25 µm of elevation at an 8-mm chord. Via slitlamp, average treatment zone area was 12.73±4.62 mm2 and 13 lenses decentered. From tomography, average treatment zone area was 7.16±2.56 mm2 and 17 were decentered. Tomography treatment zone area was negatively correlated with central corneal astigmatism (R2=0.60) and elevation at an 8-mm chord (R2=0.64, both P<0.001). CONCLUSIONS: For tomography images, central corneal astigmatism was highly correlated with peripheral elevation and may be a more expedient measure for clinical use. Treatment area decreased as corneal astigmatism and elevation increased.

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.

Randomized Clinical Trial of Near Visual Performance with Digital Devices Using Spherical and Toric Contact Lenses.

SIGNIFICANCE: Visual demands today incorporate a significant amount of time using digital devices. Results of this randomized crossover study of spherical and toric contact lenses demonstrated that participants were able to read smaller print size more comfortably and preferred toric contact lenses when using digital devices. PURPOSE: The purpose of this study was to assess how toric contact lens correction affects subjective and objective outcomes of astigmatic patients using real-world digital devices. METHODS: Adult participants, aged between 20 and 38 years with -0.75 to -1.50 D of astigmatism were enrolled in this double-masked randomized crossover 10-day study of Alcon Dailies Aqua Comfort Plus Sphere and Toric (Alcon, Geneva, Switzerland) contact lenses. Electronic high- and low-contrast near logMAR visual acuity and contrast sensitivity were tested. Reading performance was assessed using custom iPad applications; one used a reading sentences test, whereas the other analyzed zoom, contrast, and distance with website-based articles. Participants completed the Near Activity Visual Questionnaire and stated their preferred contact lens correction. RESULTS: Thirty seven participants were screened, 35 participants were enrolled, and 34 participants completed the study. Toric lens correction improved near high- and low-contrast visual acuity by 0.5 to 1 full line (P < .0001) and allowed participants to read one line smaller text on the iPad (P = .01). Participants increased the zoom 11% (P = .004) and the contrast 4% (P = .006) more with spherical lenses while reading articles. Participants held the iPad at approximately the same distance, about 33 cm (P = .63). Eighty five percent of participants preferred the toric correction (P < .0001). Participants reported improved satisfaction with toric lens correction (P = .0002) and noticed the most benefit with tasks such as reading small print and labels/instructions. CONCLUSIONS: This study used digital devices to demonstrate realistic benefits of toric contact lens designs for astigmatic patients.