Extract from Aronia melanocarpa, Lonicera caerulea, and Vaccinium myrtillus Improves near Visual Acuity in People with Presbyopia.

Presbyopia is a global problem with an estimated 1.3 billion patients worldwide. In the area of functional food applications, dietary supplements or herbs, there are very few reports describing the positive effects of their use. In the available literature, there is a lack of studies in humans as well as on an animal model of extracts containing, simultaneously, compounds from the polyphenol group (in particular, anthocyanins) and iridoids, so we undertook a study of the effects of a preparation composed of these compounds on a condition of the organ of vision. Our previous experience on a rabbit model proved the positive effect of taking an oral extract of Cornus mas in stabilizing the intraocular pressure of the eye. The purpose of this study was to evaluate the effect of an orally administered ternary compound preparation on the status of physiological parameters of the ocular organ. The preparation contained an extract of the chokeberry Aronia melanocarpa, the honeysuckle berry Lonicera caerulea L., and the bilberry Vaccinium myrtillus (hereafter AKB) standardized for anthocyanins and iridoids, as bioactive compounds known from the literature. A randomized, double-blind, cross-over study lasting with a "wash-out" period of 17 weeks evaluated a group of 23 people over the age of 50, who were subjects with presbyopia and burdened by prolonged work in front of screen monitors. The group of volunteers was recruited from people who perform white-collar jobs on a daily basis. The effects of the test substances contained in the preparation on visual acuity for distance and near, sense of contrast for distance and near, intraocular pressure, and conjunctival lubrication, tested by Schirmer test, LIPCOF index and TBUT test, and visual field test were evaluated. Anthocyanins (including cyanidin 3-O-galactoside, delphinidin 3-O-arabinoside, cyanidin 3-O-glucoside, cyanidin 3-O-rutinoside, cyanidin 3-O-arabinoside) and iridoids (including loganin, sweroside, loganic acid) were identified as substances present in the extract obtained by HPLC-MS. The preliminary results showed that the composition of AKB applied orally does not change visual acuity in the first 6 weeks of administration. Only in the next cycle of the study was an improvement in near visual acuity observed in 92.3% of the patients. This may indicate potential to correct near vision in presbyopic patients. On the other hand, an improvement in conjunctival wetting was observed in the Schirmer test at the beginning of week 6 of administration in 80% of patients. This effect was weakened in subsequent weeks of conducting the experiment to 61.5%. The improvement in conjunctival hydration in the Schirmer test shows the potential beneficial effect of the AKB formulation in a group of patients with dry eye syndrome. This is the first study of a preparation based on natural, standardized extracts of chokeberry, honeysuckle berry, and bilberry. Preliminary studies show an improvement in near visual acuity and conjunctival hydration on the Schirmer test, but this needs to be confirmed in further studies.

Simulation of daily soft multifocal contact lenses using SimVis Gekko: from in-vitro and computational characterization to clinical validation.

Multifocal contact lenses (MCLs) are one of the solutions to correct presbyopia, but their adoption is not widespread. To address this situation, visual simulators can be used to refine the adaptation process. This study aims to obtain accurate simulations for a visual simulator (SimVis Gekko; 2EyesVision) of daily soft MCL designs from four manufacturers. In-vitro characterization of these MCLs-several powers and additions- was obtained using NIMO TR-1504. From the averaged relative power profiles across powers, phase maps were reconstructed and the Through-Focus Visual Strehl metric was calculated for each MCL design. The SimVis Gekko simulation corresponding to each MCL design was obtained computationally and bench-validated. Finally, the MCL simulations were clinically validated involving presbyopic patients. The clinical validation results show a good agreement between the SimVis Gekko simulations and the real MCLs for through-focus visual acuity (TF-VA) curves and VA at three real distances. All MCL designs showed a partial correlation higher than 0.90 and a Root Mean Square Error below 0.07 logMAR between the TF-VA of simulations and Real MCLs across subjects. The validity of the simulation approach using SimVis Gekko and in-vitro measurements was confirmed in this study, opening the possibility to accelerate the adaptation of MCLs.

Visual outcomes and patient satisfaction after implantations of three types of presbyopia-correcting intraocular lenses that have undergone corneal refractive surgery.

This prospective, non-randomized, comparative study aimed to compare the visual outcomes and patient satisfaction after implantations of three presbyopia-correcting intraocular lenses (IOLs) after myopic refractive surgery. It was conducted from January 2020 to December 2021 in Shanghai Heping Eye Hospital. Patients were divided into three groups based on the type of IOL implanted. The visual acuity, refractive stability, high-order aberrations, objective visual quality, spectacle independence, and visual function index 14 questionnaire scores of the three groups were compared. This study included 78 eyes of 39 patients: 26 eyes with 839MP, 26 eyes with MF30, and 26 eyes with ZXR00. Uncorrected distance visual acuity improved significantly for all three groups. For a pupil diameter of 4.0 mm, the spherical aberrations of the three groups were 0.33 ± 0.16 µ, 0.50 ± 0.08 µ, and 0.39 ± 0.10 µ, respectively. The spectacle independence for distance vision was over 90% in each group; for near vision, it was only 25% for the ZXR00 group. All three types of presbyopia-correcting IOLs improved visual quality in post-LASIK or PRK patients. However, the high incidence of photic phenomena after presbyopia-correcting IOL implantation in patients who have undergone myopic LASIK should not be neglected.

Symptomatic Presbyopia may Develop Earlier in Patients With Glaucoma-A Cross-Sectional Retrospective Cohort Study.

Purpose: The purpose of this study was to explore risk factors for symptomatic presbyopia, defined as near add power ≥1.50 diopters, in patients with glaucoma. Methods: Treated glaucoma (n = 56), untreated glaucoma (n = 21), and control individuals (n = 376), aged 40 to 55 years at first visit, were enrolled in the study, and near add power, retinal thickness, and visual field were examined. The association between near add power and ocular parameters and the odds ratios (ORs) for symptomatic presbyopia were investigated. Survival analysis for symptomatic presbyopia was conducted. Results: Age, astigmatic power, mean deviation, and ganglion cell complex thickness were associated with near add power. The OR for symptomatic presbyopia was significant for age (OR = 1.51), astigmatism (OR = 1.01), mean deviation (OR = 0.72), ganglion cell complex thickness (OR = 0.98), treated and untreated glaucoma (OR = 2.09), and use of glaucoma eye drops (OR = 3.33). Survival analysis showed that the treated glaucoma group reached the near add power endpoint of ≥1.50 D (symptomatic presbyopia) significantly earlier than the other two groups, and there was no difference between the control and untreated glaucoma groups. Conclusions: Glaucoma patients treated with eye drops may start near correction earlier. Translational Relevance: Symptomatic presbyopia may develop earlier in patients with glaucoma, and our findings could further contribute to better management and understanding of presbyopia with glaucoma.

Comparative efficacy and safety of all kinds of intraocular lenses in presbyopia-correcting cataract surgery: a systematic review and meta-analysis.

PURPOSE: To assess the efficacy and safety of various intraocular lenses (IOLs), including standard monofocal, bifocal, trifocal, extended depth of focus (EDOF), and enhanced monofocal IOLs, post-cataract surgery through a network meta-analysis. METHODS: A systematic search of PubMed, Cochrane Library, and Web of Science was conducted to identify relevant studies from the past 5 years. Parameters such as binocular visual acuities, spectacle independence, contrast sensitivity (CS), and optical quality were used to evaluate efficacy and safety. Data from the selected studies were analyzed using Review Manager 5.4 and STATA 17.0 software. RESULTS: Twenty-eight Randomized Controlled Trials (RCTs) comprising 2465 subjects were included. Trifocal IOLs exhibited superior uncorrected near visual acuity (UNVA) compared to monofocal IOLs (MD: -0.35; 95% CI: -0.48, -0.22). Both trifocal (AcrySof IQ PanOptix IOLs group MD: -0.13; 95% CI: -0.21, -0.06) and EDOF IOLs (MD: -0.13; 95% CI: -0.17, -0.09) showed better uncorrected intermediate visual acuity (UIVA) than monofocal IOLs. Trifocal IOLs ranked highest in spectacle independence at various distances (AT LISAtri 839MP group: SUCRA 97.5% for distance, 80.7% for intermediate; AcrySof IQ PanOptix group: SUCRA 83.0% for near). CONCLUSIONS: For cataract patients who want to treat presbyopia, trifocal IOLs demonstrated better visual acuity and spectacle independence at near distances. Different types of trifocal IOL characteristics differ. EDOF and enhanced monofocal IOLs have improved visual quality at intermediate distances.Therefore, It is very important to select the appropriate IOLs based on the lens characteristics and patient needs.

Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items.

BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.

The effect on income of providing near vision correction to workers in Bangladesh: The THRIVE (Tradespeople and Hand-workers Rural Initiative for a Vision-enhanced Economy) randomized controlled trial.

INTRODUCTION: Presbyopia, the leading cause of vision impairment globally, is common during working years. However, no trials have assessed presbyopia's impact on income. METHODS: In April 2017, we conducted a census among 59 Bangladesh villages to identify persons aged 35 to 65 years with presbyopia (presenting distance vision > = 6/12 bilaterally and correctable inability to see 6/13 at 40 cm with both eyes), who never had owned glasses. Participants were randomized (1:1) to receive immediate free reading glasses (intervention) or glasses delivered 8 months later (control). Visual demand of different jobs was stratified into three levels. Outcomes were between-group differences in the 8 month change in: self-reported monthly income (primary) and Near Vision Related Quality of Life (NVRQOL, secondary). RESULTS: Among 10,884 census participants, 3,655 (33.6%) met vision criteria and 863 (23.6%) comprised a sample enriched for near vision-intensive jobs, but 39 (4.52%) could not be reached. All participants allocated to intervention (n = 423, 51.3%) and control (n = 401, 48.7%) received the appropriate intervention, and follow-up was available for 93.4% and 96.8% respectively. Groups were similar at baseline in all characteristics: mean age was 47 years, 50% were male, 35% literate, and about half engaged in "most near vision-intensive" occupations. Glasses wear at 8-month follow-up was 88.3% and 7.81% in intervention and control respectively. At baseline, both the intervention and control groups had a self-reported median monthly income of US$35.3. At endline, the median income for the intervention group was US$47.1 compared with US$35.3 for control, a difference of 33.4%. Predictors of greater income increase in multivariate models included intervention group allocation (OR 1.45, 95% CI 1.12, 1.88, P = 0.005), male sex (OR 2.41, 95% CI 1.84, 3.16, P <0.001), and not engaging in income-producing work at baseline (OR 2.35, 95% CI 1.69, 3.26, P<0.001). CONCLUSION: Provision of reading glasses increases income in near vision-intensive occupations, and may facilitate return to work for those currently unemployed.

Efficacy of a new refractive multifocal contact lens for presbyopia.

This prospective single-arm study aimed to evaluate the clinical efficacy and safety of a refractive multifocal contact lens for the correction of presbyopia in 22 patients. The participants underwent clinical examinations before and 1 week after wearing a refractive multifocal contact lens (OptaCon ZOOM). The primary endpoints were the corrected distance visual acuity (CDVA) and distance-corrected near visual acuity (DCNVA). Defocus curve, contrast sensitivity, and ocular surface disease index (OSDI) were analyzed. A slit-lamp examination was performed for safety analysis. Contact lens comfort and patient satisfaction were assessed using a questionnaire. No significant difference in CDVA was observed before and 1 week after refractive multifocal contact lens use (p = 0.127), whereas DCNVA was significantly improved after 1 week (p < 0.001). The contrast sensitivity was not significantly affected at any spatial frequency under mesopic or photopic conditions. OSDI was significantly increased (p = 0.023). The patient-reported satisfaction scores were 96.2, 91.9, and 85.0 out of 100 at far, intermediate, and near distances, respectively. No significant adverse events were observed. Refractive multifocal contact lenses improved near vision while maintaining distance vision in presbyopic patients, without compromising contrast sensitivity. The study results suggest that OptaCon ZOOM can be considered safe and effective for the correction of presbyopia.

Sex as a risk factor regarding presbyopia in the rhesus monkey.

PURPOSE: To determine the effect of sex as a risk factor regarding presbyopia. METHODS: Maximum accommodation was pharmacologically induced (40% cabachol corneal iontophoresis) in 97 rhesus monkeys (49 males and 48 females) ranging in age from 8 to 36 years old. Accommodation was measured by Hartinger coincidence refractometry. RESULTS: Accommodative amplitude measured refractometrically decreased with age, and the rate of change was not different between males and females (p = 0.827). CONCLUSIONS: Presbyopia is essentially sex neutral, and no one is spared. There may be modest variations between different populations for various reasons, but essentially it is monotonously predictable. At present there is no biological therapeutic.

Comparison of Two Presbyopia-Correcting Trifocal Intraocular Lenses: A Prospective Study.

Objectives: To evaluate the clinical results of a new trifocal intraocular lens (IOL) with sinusoidal design by comparing with a traditional trifocal IOL. Materials and Methods: A total of 79 patients undergoing uneventful microincisional cataract surgery with bilateral implantation of one of two types of trifocal IOLs, the Acriva Trinova IOL (VSY) or Acrysof IQ PanOptix IOL (Alcon), were enrolled in this prospective study. Visual and refractive outcomes, contrast sensitivity (CS), and defocus curve were assessed at 3 months after surgery. Patient satisfaction and incidence of photic phenomena were also evaluated. Results: The number of patients/eyes were 48/96 in the Trinova group and 31/62 in the PanOptix group. There were no significant differences between the groups for monocular and binocular corrected/uncorrected distance or intermediate (at 60 cm) and near visual acuities (VA) postoperatively. The Trinova group had statistically significantly better intermediate VA at 80 cm than the PanOptix group (p<0.05). The CS results of both groups were within the normal limits. In the binocular defocus curve of both IOLs, we observed a peak of good VA at 0.0 diopters defocus and a useful wide range for intermediate distances. The incidence of photic phenomena in the Trinova group was lower at postoperative 1 month (p<0.05) but this difference disappeared at 3 months. A total of 47 patients (97.9%) in the Trinova group and 30 patients (96.7%) in the PanOptix group stated that they would recommend the same IOL. Conclusion: Both trifocal IOLs provide good visual quality outcomes and patient satisfaction.

Vergence-Accommodation Conflict: Increased Presbyopia in Virtual Reality.

BACKGROUND: Performance and symptoms in completing a visual search task on a PC monitor and using a head-mounted display (HMD) were compared for different viewing conditions and between users of different ages. PATIENTS AND METHODS: Twenty-three young (M = 30 y, SD = 7 y) and 23 older (M = 52 y, SD = 5 y) participants performed a visual search task presented on a PC monitor. The task was repeated using an HMD for a near and a far virtual viewing distance. Reaction times (RT), detection sensitivity (d'), and symptoms were recorded for the three different viewing conditions. RESULTS: RT and d' were not affected by the viewing condition (p > 0.05). In contrast, symptoms significantly depended on the viewing condition but were, in part, not significantly affected by age. It is interesting to note that although not significant, young participants reported more ocular symptoms than older participants in the near vision task carried out using the HMD. DISCUSSION: HMD increases visual symptoms. However, HMD could be, in part, a remedy to problems when using visual aids for near work, in particular for presbyopes.

Understanding accommodative control in the clinic: Modeling latency and amplitude for uncorrected refractive error, presbyopia and cycloplegia.

Accommodation is the process of adjusting the eye's optical power so as to focus at different distances. Uncorrected refractive error and/or functional presbyopia mean that sharp focus may not be achievable for some distances, so observers experience sustained defocus. Here, we identify a problem with current models of accommodative control: They predict excessive internal responses to stimuli outside accommodative range, leading to unrealistic adaptation effects. Specifically, after prolonged exposure to stimuli outside range, current models predict long latencies in the accommodative response to stimuli within range, as well as unrealistic dynamics and amplitudes of accommodative vergence innervation driven by the accommodative neural controller. These behaviors are not observed empirically. To solve this issue, we propose that the input to blur-driven accommodation is not retinal defocus, but correctable defocus. Predictive models of accommodative control already estimate demand from sensed defocus, using a realistic "virtual plant" to estimate accommodation. Correctable defocus can be obtained by restricting this demand to values physically attainable by the eye. If we further postulate that correctable defocus is computed using an idealized virtual plant that retains a young accommodative range, we can explain why accommodative-convergence responses are observed for stimuli that are too near-but not too far-to focus on. We model cycloplegia as a change in gain, and postulate a form of neural myopia to explain the additional relaxation of accommodation often seen with cycloplegia. This model produces plausible predictions for the accommodative response and accommodative convergence signal in a wide range of clinically relevant situations.

Correlation analysis of angles κ and α with the refraction and anterior segment parameters in children.

AIM: To investigate the correlation of angles α and κ with the refractive and biological parameters in children. METHODS: This case-series study included 438 eyes of 219 children (males/females = 105/114, age: 3-15 years). Ocular biometric parameters, including axial length, corneal radius of curvature (CR), white-to-white distance (WTW), angle κ and angle α, were measured using IOL Master 700; auto-refraction were assessed under cycloplegia. The eyes were assigned to different groups based on CR, WTW, and gender to compare the angles α and κ, and analyze the correlations between the differences of biological parameters on angles α and κ. RESULTS: The means of axial length, CR, WTW, angle α, and angle κ were 23.24 ± 1.14 mm, 7.79 ± 0.27 mm, 11.68 ± 0.41 mm, 0.45 ± 0.25 mm, and 0.27 ± 0.22 mm, respectively. Angle α was correlated with CR and WTW (fixed effect coefficient [FEC] = 0.237, p = 0.015; FEC = -0.109, p = 0.003; respectively), and angle κ also correlated with CR and WTW (FEC = 0.271, p = 0.003; FEC = -0.147, p < 0.001, respectively). Comparing subgroups, the large CR and small WTW group had larger angles α (0.49 ± 0.27 vs. 0.41 ± 0.21, p < 0.001; 0.46 ± 0.27 vs. 0.44 ± 0.21, p < 0.05, respectively) and κ (0.29 ± 0.25 vs. 0.24 ± 0.15, p < 0.01; 0.29 ± 0.25 vs. 0.26 ± 0.19, p < 0.05, respectively). The differences in interocular angles α and κ showed correlation with interocular WTW (r = - 0.255, p < 0.001; r = - 0.385, p < 0.001). Eyes with smaller WTW tended to have larger angle κ (0.28 ± 0.27 vs. 0.25 ± 0.15, p < 0.05). CONCLUSION: The size of angle α/κ may be correlated to CR and WTW, and a larger WTW eye may suggest a smaller angle κ compared with the fellow eye.

Model of zonular forces on the lens capsule during accommodation.

How the human eye focuses for near; i.e. accommodates, is still being evaluated after more than 165 years. The mechanism of accommodation is essential for understanding the etiology and potential treatments for myopia, glaucoma and presbyopia. Presbyopia affects 100% of the population in the fifth decade of life. The lens is encased in a semi-elastic capsule with attached ligaments called zonules that mediate ciliary muscle forces to alter lens shape. The zonules are attached at the lens capsule equator. The fundamental issue is whether during accommodation all the zonules relax causing the central and peripheral lens surfaces to steepen, or the equatorial zonules are under increased tension while the anterior and posterior zonules relax causing the lens surface to peripherally flatten and centrally steepen while maintaining lens stability. Here we show with a balloon capsule zonular force model that increased equatorial zonular tension with relaxation of the anterior and posterior zonules replicates the topographical changes observed during in vivo rhesus and human accommodation of the lens capsule without lens stroma. The zonular forces required to simulate lens capsule configuration during in vivo accommodation are inconsistent with the general belief that all the zonules relax during accommodation.

A comparative study of two presbyopia-correcting intraocular lenses combining bifocal and extended depth-of-focus profiles.

OBJECTIVE: To compare the visual performance of two presbyopia-correcting intraocular lenses (IOLs) that combine both bifocal and extended depth-of-focus profiles, Artis® Symbiose® Plus (Symbiose Plus; Cristalens Industrie, Lannion, France) and Tecnis® Synergy® (Synergy; Johnson & Johnson Vision, Santa Ana, CA, USA). METHODS: The medical records of patients with cataract bilaterally implanted with either Symbiose Plus or Synergy between January 2022 and January 2023 were assessed. The principal measures of postoperative findings included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near (40 and 33 cm) visual acuity (UNVA), objective optical quality (OOQ) parameters, distance-corrected defocus curve analysis, and surveys of subjective satisfaction. RESULTS: Total of 96 eyes from 48 patients were enrolled. Each group was equally composed of 24 patients, 48 eyes. There were no significant differences between the two groups on baseline characteristics. Both IOLs displayed excellent binocular UDVA, CDVA, and UNVA (40 and 33 cm) with no statistical difference (p = 0.467(UDVA), p = 0.584(CDVA), p = 0.096(40-cm UNVA), and p = 0.621(33-cm UNVA)). However, with regard to UIVA, the Synergy group showed significantly superior results (p < 0.001). In contrast, the Symbiose Plus group showed significantly better results on OOQ parameters and patient-reported quality of vision survey outcomes (both p < 0.001). CONCLUSIONS: Both IOLs provided a decent continuous range of vision from near to far distance.

2022 Glenn A. Fry Award lecture: Enhancing clinical assessment for improved ophthalmic management.

ABSTRACT: Detailed clinical assessment is critical to allow sensitive evaluation of the eye and its management. As technology advances, these assessment techniques can be adapted and refined to improve the detection of pathological changes of ocular tissue and their impact on visual function. Enhancements in optical medical devices including spectacle, contact, and intraocular lenses have allowed for a better understanding of the mechanism and amelioration of presbyopia and myopia control. Advancements in imaging technology have enabled improved quantification of the tear film and ocular surface, informing diagnosis and treatment strategies. Miniaturized electronics, large processing power, and in-built sensors in smartphones and tablets capacitate more portable assessment tools for clinicians, facilitate self-monitoring and treatment compliance, and aid communication with patients. This article gives an overview of how technology has been used in many areas of eye care to improve assessments and treatment and provides a snapshot of some of my studies validating and using technology to inform better evidence-based patient management.

Objective and subjective assessment of accommodative insufficiency.

SIGNIFICANCE: A variety of subjective and objective procedures are available to measure the amplitude of accommodation. However, it is unclear whether the standard criterion of Hofstetter's minimum minus 2 D can be used to diagnose accommodative insufficiency with each of these techniques. PURPOSE: The use of objective dynamic retinoscopy and three subjective techniques to diagnosis accommodative insufficiency was examined. METHODS: A total of 632 subjects between 8 and 19 years of age were enrolled. Accommodative lag, monocular accommodative facility, and subjective (push-up, modified push-down, and minus lens) and objective (dynamic retinoscopy) amplitude of accommodation were quantified. Accommodative insufficiency was diagnosed based on Hofstetter's minimum minus 2 D for each subjective method, as well as adding an additional subjective criterion (either accommodative lag exceeding 0.75 D or monocular accommodative facility falling below the age-expected norms). RESULTS: The prevalence of accommodative insufficiency was lowest and highest with the push-up (7.9 and 1%) and dynamic retinoscopy (94 and 12%) procedures when measured without and with the additional subjective criteria, respectively. Comparing the validity of dynamic retinoscopy against the traditional criterion, moderate to low sensitivity and high specificity were found. However, adding the additional subjective criteria improved the findings with moderate to high sensitivity and high specificity. Using a cutoff for dynamic retinoscopy of 7.50 D showed moderate diagnostic accuracy based on likelihood ratios. CONCLUSIONS: It is clear that a revised definition of accommodative insufficiency is required, which must include the method of assessing accommodation. The various objective and subjective methods for quantifying the amplitude of accommodation are not interchangeable, and subjective assessment does not provide a valid measure of the accommodative response.

Content development for a new item-bank for measuring multifocal contact lens performance.

BACKGROUND: Presbyopia is an age-related condition that causes a decreased ability to focus on nearby objects. Multifocal contact lenses are commonly used to address this issue. However, there seems to be a notable dissatisfaction among multifocal contact lens wearers. The absence of a reliable instrument to measure the patient's perspective, despite the widespread use of this method, highlights the need for further research in this area. OBJECTIVE: The objective of this study is to develop an item-bank integrating all domains necessary to assess the patient's perspective on multifocal contact lens performance, offering a comprehensive measure. The item-bank will ensure a high level of content validity, be self-administered, and will initially be available in Spanish. The aim of this tool is to serve as a valuable resource for research and optometric clinics, facilitating the follow-up of patients with presbyopia who wear multifocal contact lenses or those who are newly starting to use them. METHODOLOGY: The MCL-PRO item bank, followed a systematic and step-wise inductive approach to gather information, following the recommendations outlined in the COSMIN guidelines and similar studies. The process involved the following steps: (1) Literature review and relevant existing items identification (2) Social media review, (3) Semi-structured focus groups, (4) performing qualitative analysis, (5) refining and revising the items, and (6) generating the content of the item bank. RESULTS: A total of 575 items were included in the item-bank hosted under 8 different domains that were found to be important for presbyopic population: visual symptoms (213), activity limitation (111), ocular symptoms (135), convenience (36), emotional well-being (33), general symptoms (16), cognitive issues (21) and economic issues (10). CONCLUSION: The item-bank created has followed standardised methodology for its development and encloses all the aspects for MCL performance evaluation from patients perspective.

Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials.

PURPOSE: This study was undertaken to evaluate the safety and efficacy of CSF-1 (0.4% pilocarpine hydrochloride ophthalmic solution) for use in individuals with presbyopia. METHODS: Two Phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trials were conducted in 35 private ophthalmology clinics in the United States from October 2020 to February 2022. Key inclusion criteria were the following: (1) age 45-64 years, (2) distance-corrected near visual acuity (DCNVA) at 40 cm ≥0.40 and ≤0.90 logarithm of the minimum angle of resolution (logMAR, approximately 20/50-20/160 Snellen) in at least 1 eye, (3) manifest refraction (MR) between -4.50 and +2.00 diopter (D) sphere in each eye with ≤2.00D difference between eyes, (4) <2.00D of cylinder MR in each eye, (5) ≤0.04 logMAR (20/20-2 or better) corrected distance visual acuity (CDVA) at 4 m in each eye. Key exclusion criteria were the following: (1) >0.14 logMAR (7 letters) improvement in post-vehicle treatment in monocular DCNVA in either eye at visit 1, (2) introcular pressure (IOP) <9 or >22 mm Hg, (3) average dark-adapted pupillometry <3.5 mm in either eye, (4) prior refractive surgery or intraocular lens (IOL) implantation. Participants applied CSF-1 or vehicle twice per day for 2 weeks. Efficacy and safety assessments were performed at several times on days 1, 8, and 15. Response was defined as ≥3-line gain in DCNVA without loss of ≥1-line in CDVA in the study eye under mesopic room lighting conditions. The primary efficacy endpoint was measured 1 hour post-dose 1 on day 8. Key secondary endpoints were 2 hours post-dose 1, and 1 and 2 hours post-dose 2, also on day 8. Safety endpoints were ocular and non-ocular treatment-related adverse events (TRAE), conjunctival redness, drop comfort, slit-lamp biomicroscopy, intraocular pressure, indirect fundoscopy, and CDVA at 4 m. FINDINGS: Six hundred thirteen participants were randomized to CSF-1 (n = 309) or vehicle (n = 304). Participants were predominantly White (80.8%) and female (62.0%), with mean age (standard deviation) of 54.7 (4.8). CSF-1 met the primary and key secondary endpoints. At the primary endpoint, 40.1% of the CSF-1 group achieved response versus 19.1% of the vehicle group (P < 0.0001). The percentage of responders was significantly greater in CSF-1 compared with vehicle at all tested times. Changes from baseline in all safety endpoints were comparable between groups. Most adverse events (AEs) were mild and transient. Neither serious nor severe AEs were reported with CSF-1. IMPLICATIONS: CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without compromising distance vision. CSF-1 demonstrated a favorable safety profile. CLINICALTRIALS: gov identifier: NCT04599933 (NEAR-1), NCT04599972 (NEAR-2).

Multifocal contact lens success predictability.

PURPOSE: The current multi-study analysis combined data from three studies to quantify the relationship between the initial reaction to soft multifocal contact lens (MFCL) design types at dispensing and evaluate the predictability of overall vision satisfaction (OVS) and intention to purchase (ITP) after 1 week of wear. METHOD: Three prospective studies tested MFCLs over 1-week of wear following the same protocol, using a range of potentially predictive ratings at dispensing, and both OVS and ITP at 1-week as an indicator acceptance level. In each study, two of MyDay® multifocal, clariti® 1 day multifocal, Biofinity® multifocal (worn as a daily disposable lens) or 1 DAY ACUVUE® MOIST MULTIFOCAL were dispensed for 1-week of daily wear. OVS was recorded on a 100-point VAS and ITP on a 5-point LIKERT scale. Fourteen possible predictors were entered in the statistical model, and predictability was assessed using Chi-square Automatic Interaction Detector (CHAID) statistical test. RESULTS: A total of 210 participants (152 female & 58 male; 53.9 ± 6.5 years, range 41-71 years), representing 420 MFCL fits, equally distributed between emergent n = 65, established n = 70 and advanced n = 75 presbyopes, completed the studies. OVS on dispensing was the predictor of both OVS (p < 0.001) and ITP (p < 0.001) at 1-week. For OVS predictability, 70.8 % with OVS at dispensing > 91 points reported good OVS at 1-week and 73.4 % with OVS on dispensing ≤ 80 points reported poor OVS at 1-week. For ITP predictability, 74.6 % with OVS at dispensing > 94 points reported a positive ITP at 1-week and 65.9 % with OVS on dispensing ≤ 63 points reported negative ITP at 1-week. CONCLUSION: Overall vision satisfaction at the time of dispensing MFCLs is a powerful indicator of both OVS and ITP after 1-week of wear. Initial patient subjective assessments provide a clinically useful indicator of the likeliness of success.