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).

Nationwide Rapid Assessment of Avoidable Blindness (RAAB) in Armenia.

PURPOSE: This study aimed to estimate the prevalence and main causes of blindness and visual impairment in population aged 50 years and older in Armenia using Rapid Assessment of Avoidable Blindness (RAAB) methodology. METHODS: The study team randomly selected 50 clusters (each consisting of 50 people) from all 11 regions of Armenia. Data on participants' demographics, presenting visual acuity, pinhole visual acuity, principal cause of presenting visual acuity, spectacle coverage, uncorrected refractive error (URE), and presbyopia were collected using the RAAB survey form. Four teams of trained eye care professionals completed data collection in 2019. RESULTS: Overall, 2,258 people of 50 years and older participated in the study. The age- and gender- adjusted prevalence of bilateral blindness, severe and moderate visual impairment were 1.5% (95% CI: 1.0-2.1), 1.6% (95% CI: 1.0-2.2) and 6.6% (95% CI: 5.5-7.7), respectively.The main causes of blindness were cataract (43.9%) and glaucoma (17.1%). About 54.6% and 35.3% of participants had URE and uncorrected presbyopia, respectively. The prevalence of bilateral blindness and functional low vision increased with age and was the highest in participants 80 years and older. CONCLUSION: The rate of bilateral blindness was comparable with findings from countries that share similar background and confirmed that untreated cataract was the main cause of blindness. Given that cataract blindness is avoidable, strategies should be developed aiming to further increase the volume and quality of cataract care in Armenia.

RHEGMATOGENOUS RETINAL DETACHMENT AFTER INITIATION OF PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION 1.25% FOR TREATMENT OF PRESBYOPIA.

BACKGROUND/PURPOSE: Retinal detachment has previously been reported in association with topical miotic use for the treatment of glaucoma. Pilocarpine hydrochloride 1.25% was recently approved by the Food and Drug Administration for the treatment of presbyopia, with no reports of associated retinal detachments in the clinical trial data. METHODS: Case report. RESULTS: Two novel cases of unilateral retinal detachment occurring within 10 days of the initiation of pilocarpine 1.25% for the treatment of presbyopia were described. The patients were pseudophakic men in their 60s or 70s with preexisting retinal detachment risk factors, such as high myopia, lattice degeneration, and prior retinal detachment. Both affected eyes were treated with pars plana vitrectomy and gas endotamponade with an uncomplicated postoperative course. CONCLUSION: Retinal detachment may be associated with the use of pilocarpine 1.25%. Caution should be used when considering prescribing this medication in patients with preexisting retinal abnormality.

Managing low corneal astigmatism in patients with presbyopia correcting intraocular lenses: a narrative review.

Cataract surgery has become a refractive procedure in which emmetropia is the goal, with the implantation of extended depth-of-focus or multifocal intraocular lenses (IOLs) being the commonly selected option to restore vision beyond the far distance. The selection criteria for implanting these lenses can differ from those for monofocal IOLs and even between technologies, as eye characteristics can affect postoperative visual performance. Corneal astigmatism is an eye characteristic that can affect visual performance differently, depending on the implanted IOL. The magnitude of corneal astigmatism, the tolerance of the IOL to this astigmatism, economic aspects, comorbidities, and the efficacy of astigmatism treatment are factors that can make surgeons' doubt as to what astigmatism treatment should be applied to each patient. This review aims to summarize the current evidence related to low astigmatism tolerance in presbyopia-correcting lenses, the efficacy achieved through corneal incisions, and their comparison with the implantation of toric IOLs.

Prevalence and determinants of asthenopia among ophthalmologists in China: a national cross-sectional survey.

Introduction: The role of ophthalmologists is defined by tasks requiring visual effort, emphasizing the importance of examining their condition within the realm of occupational visual health. Our goal was to explore the occurrence of asthenopia among Chinese ophthalmologists and identify contributing factors through the use of a reliable and validated survey instrument. Methods: A national cross-sectional online survey was carried out in June 2017, involving 6,220 practicing ophthalmologists in China. Utilizing an 11-item Asthenopia Survey Questionnaire with established reliability and validity. Prevalence rates of asthenopia among subgroups categorized by age, gender, hospital classification, physician level, daily near vision activity duration, sleep duration, sleep quality, presbyopia status, and history of eye surgery were determined using the independent t-test, chi-square test and bonferroni test. Multiple logistic regression analysis was employed to pinpoint independent factors linked to asthenopia. Results: Out of the 5,009 ophthalmologists who completed the survey, a 40.7% prevalence of asthenopia was identified. Multivariate analysis revealed that good sleep quality (OR: 0.24, 95%CI: 0.20-0.30), moderate sleep quality (OR: 0.47, 95%CI: 0.38-0.59), engaging in daily near vision activities for less than 7 h (OR: 0.76, 95%CI: 0.68-0.86), having daily sleep duration exceeding 7 h (OR: 0.87, 95%CI: 0.77-0.98), and working in tertiary hospitals (OR: 0.88, 95%CI: 0.78-0.99) were protective factors against asthenopia. Conversely, presbyopia was identified as a risk factor (OR: 1.33, 95%CI: 1.04-1.70). All calculated p values were below 0.05. Age, gender, physician level, and eye surgery history were not related factors. Conclusion: Asthenopia is prevalent among Chinese ophthalmologists, with employment in tertiary hospitals providing a protective effect and presbyopia is a risk factor. Preventive strategies include improving sleep quality, restricting daily near vision activity to under 7 h, and extending daily sleep duration to over 7 h. Further investigation is needed to explore the protective implications of working in tertiary hospitals.

Presbyopia correction with a new Extended Depth of Focus Intraocular Lens.

Extended depth of focus intraocular lenses (EDoF IOLs) offer an expanded number of modalities for simultaneous cataract and presbyopia treatment. The objective of the current study was to assess clinical outcomes with a new mono-EDoF intraocular lens and to analyze the effect of different parameters on postoperative results. The inclusion criteria were defined as uneventful cataract surgery, no history of concomitant ocular disease, implantation of ZOE Primus-HD lens. Parameters from IOL Master 500 were analyzed. The main outcome measures were postoperative uncorrected distance (UDVA) and intermediate (UIVA) visual acuity. The study included 39 eyes of 37 patients (15 males and 22 females) with a mean age of 73.59±7.71. Postoperatively, the UDVA improved to 0.84±0.16 (p<0.001) and UIVA was 0.86±0.14. There was no correlation between K1, K2 and IOL power with both postoperative UDVA and IDVA. Moreover, there was no statistically significant difference between UDVA and UIVA between patients with mean K value over or under 44.0D (p=0.204 and p=0.817, respectively). The results of a multinomial logistic regression analysis for the predictive value of the factors K1, K2 and IOL power demonstrated no statistical significance, except for UIVA with a significant influence of IOL power (p=0.024) in patients with less than 0.9 Snellen visual acuity. The implantation of the new mono-EDoF ZOE Primus-HD lens led to improvement in both UDVA and UIVA. Patients with keratometry values less than 44.0D could still benefit from the mono-EDoF lenses. Further studies including wavefront aberrometry are needed to study the interaction between corneal aberrations and EDoF IOLs. Abbreviations: IOL = Intraocular lens, UDVA = Uncorrected distance visual acuity, UIVA = Uncorrected intermediate visual acuity, D = Diopters, EDoF = Enhanced Depth of Focus, MF IOL = Multifocal intraocular lens, AUC = area under the curve.

Retinal Detachments Associated With Topical Pilocarpine Use for Presbyopia.

PURPOSE: To present a case series of retinal detachments associated with the use of pilocarpine for presbyopia. DESIGN: Multicenter case series of 3 eyes from 2 patients. RESULTS: Patient 1, a 47-year-old man, presented with flashes and floaters in both eyes. The patient had started pilocarpine 1.25% drops 1 month prior for presbyopia in both eyes. He noted the onset of flashes and floaters 3 days after he initiated the drops. A dilated examination revealed an inferotemporal retinal detachment in the right eye with an associated retinal tear inferotemporally. The left eye demonstrated a retinal detachment in the superior quadrant with an associated horseshoe tear at 12 o'clock. Patient 2, a 46-year-old man, presented 5 weeks after initiating topical pilocarpine 1.25% drops for presbyopia. He noted a nasal visual field defect in his left eye that progressed to include his central vision. A dilated examination revealed a superior retinal detachment from 11 to 3 o'clock with subretinal fluid extending into the macula. CONCLUSIONS: Pilocarpine and other miotics have long been suspected to be associated with an increased risk of retinal detachment. Prior to prescribing pilocarpine for presbyopia, physicians should inform patients of this potential adverse event and consider that these patients undergo a screening dilated examination, particularly if they are myopic, to determine if they are at higher risk for retinal detachment. Before the initiation of therapy, patients should be appropriately informed regarding symptoms of retinal tears or detachment, which include flashes, floaters, and visual field loss.

Presbyopia developed earlier during the COVID-19 pandemic.

PURPOSE: The aim of this cohort study was to evaluate the development and progression of presbyopia and the status of dry eye-related symptoms from 2017 to 2020, to assess the impact of the COVID-19 pandemic. METHODS: Near add power at 30 cm was measured in 339 participants aged between 40 and 55 from 2017 to 2021 at Japanese eye clinics. Regression analysis of near add power and age was analyzed to compare 2017 with later years up to the pandemic. The prevalence of dry eye-related signs and six common symptoms were compared. RESULTS: The number and mean age (y) of participants were 183 (48.6±4.1) in 2017, 46 (51.3±7.5) in 2019, and 110 (49.2±3.7) in 2020-21, respectively. The mean progression rate of near add power (D/y) was 0.13 for 2017, 0.09 for 2019 (P = 0.028, vs 2017), and 0.08 for 2020-21 (P<0.001, vs 2017). The slope (rate of presbyopia progression) became flatter from 2017 to 2021 and the estimated near add power at the age of 40 increased from 2017 to 2020-2021, implicating presbyopia developed earlier and worsened during the study period. The 2017 values were comparable with previous studies described in 1922 and 2019. The standardized correlation coefficient between age and near add power was 0.816 for 2017, 0.671 for 2019 (P = 0.084, vs 2017), and 0.572 for 2020-21 (P<0.001, vs 2017). Multiple regression analysis revealed age and COVID-19 pandemic were significantly correlated with near add power. The prevalence of dryness irritation, and pain was greater in 2020-21 than in 2017 with no difference in the prevalence of eye fatigue, blurring, and photophobia. There was no difference in the prevalence of short tear break-up time and positive corneal staining among 2017, 2019 and 2020-21. CONCLUSION: Estimated presbyopia developed earlier and progressed slower from 2017 to 2021, the COVID-19 pandemic. Stress and rapid digitalization related to strict infection control and quarantine might be contributing factors.

Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study.

BACKGROUND: To contribute to the WHO initiative, VISION 2020: The Right to Sight, an assessment of global vision impairment in 2020 and temporal change is needed. We aimed to extensively update estimates of global vision loss burden, presenting estimates for 2020, temporal change over three decades between 1990-2020, and forecasts for 2050. METHODS: We did a systematic review and meta-analysis of population-based surveys of eye disease from January, 1980, to October, 2018. Only studies with samples representative of the population and with clearly defined visual acuity testing protocols were included. We fitted hierarchical models to estimate 2020 prevalence (with 95% uncertainty intervals [UIs]) of mild vision impairment (presenting visual acuity ≥6/18 and <6/12), moderate and severe vision impairment (<6/18 to 3/60), and blindness (<3/60 or less than 10° visual field around central fixation); and vision impairment from uncorrected presbyopia (presenting near vision

Thirty Year Projected Magnitude (to 2050) of Near and Distance Vision Impairment and the Economic Impact if Existing Solutions are Implemented Globally.

Purpose: Recent global, regional and country-level prevalence estimates for blindness and vision impairment will be important when designing future public health policies. The aim of this paper is to contribute to this discussion by estimating the productivity impact of known effective interventions to treat all preventable cases of vision impairment at the global, regional and country-level up to 2050. We also provide estimates of potential reduction in the number of people with vision impairment, as well as averted vision-impaired years up to 2050.Methods: We combined recent estimates of the prevalence of blindness, distance and near vision impairment with the World Bank's World Development Indicators (WDI) and estimated the global, regional and country-level productivity gains up to 2030, 2040 and 2050 from known effective interventions, primarily cataract surgery and treated uncorrected refractive errors. The magnitude of productivity gains relative to baseline depended on population size, estimated current and future prevalence of vision impairment, level of economic development, long-term wage growth, and long-term real interest rates.Results: Globally, we estimate that the number of people affected by blindness could be reduced from the estimated 114.6 million by 2050 to 58.3 million. This would be associated with over one billion blind life-years averted and US$ 984 billion in global productivity gains. These numbers are dwarfed by the impact of interventions to reduce the prevalence of Moderate and Severe Vision Impairment (MSVI) [Presenting Acuity <20/60 to 20/400 in the better-seeing eye]. We estimate that the number of people affected by MSVI could be reduced by 435.8 million people to 147.9 million by 2050. This reduction would translate to over 9 billion MSVI -life-years avoided and US$ 17 trillion in productivity gains by 2050. While other causes of VI would not be possible to eliminate completely based on current known effective treatments, low-cost interventions to eliminate VI from uncorrected presbyopia would avert 1.2 billion presbyopia life-years and achieve US$ 1.05 trillion in productivity gains by 2050. In total, the global productivity gains for all three categories are estimated to be US$ 19 trillion by 2050. East Asia makes up the greatest share of productivity gains due to the high number of people affected by VI and the region's continuing economic growth.Conclusion: Implementation of currently known and effective treatments of avoidable blindness, MSVI and presbyopia would be expected to contribute significant productivity gains to the global economy at a fraction of the estimated costs to deliver them.

Population-based study on the epidemiology of dry eye disease and its association with presbyopia and other risk factors.

BACKGROUND: To investigate the incidence and prevalence of dry eye disease (DED) in Taiwan and to explore its potential risk factors. METHODS: Population-based longitudinal data from 2000 to 2013 based on Taiwan National Health Insurance Research Database were used in this study. To explore potential risks factor of interest, patients who had DED diagnosis before the exposure were excluded. Each patient from the exposure and his/her matched non-exposure controls were followed until either the diagnosis of DED or censorship. Kaplan-Meier method was used to compare the hazard of DED between cohorts. Stratified Cox proportional hazard models were applied to estimate the adjusted effect. RESULTS: The age-adjusted prevalence for men and women were 6.81% and 16.16%, respectively. The age-gender rate of the same period was 549 per 105 person-years. The propensity-adjusted hazard ratio of DED is 1.816 for the presbyopia versus non-presbyopia (with 95% CI = [1.737, 1.897] with p value < 0.0001). CONCLUSIONS: The DED incidence for women peaked at age 50-74, while that for men peaked at age ≧ 75. The incidence in young people seems stable both for women and for men. While exploring the factors of DED, there is a significant association between presbyopia and DED even after matching age/gender and comorbidity conditions. Further clinical studies are needed to justify whether the corrective refractive treatment such as presbyopic glasses to treat the frequently hyperopic status of these patients could be beneficial to both dry eye and presbyopic condition.

Patient-specific determination of change in ocular spherical aberration to improve near and intermediate visual acuity of presbyopic eyes.

The purpose was to determine the optimum negative spherical aberration induction required to improve near and intermediate visual acuity (VA) of presbyopic eyes. A total of 174 normal and diabetic (no retinopathy) presbyopic eyes (age ≥ 40 years) were measured with visual adaptive optics simulator (Voptica, Spain). First, baseline uncorrected VA and aberrations were measured. VA at 40 cm (near), 80 cm (intermediate) and distance was measured. Then, a negative spherical aberration (SA) was added to baseline ocular SA, and VA at all targets was reassessed after correction of distance refractive error. Clinically, baseline SA and root mean square of higher order aberrations were similar between the normal and diabetic presbyopic eyes. Baseline VA of the diabetic eyes at near and intermediate was better than the same of normal eyes (P = 0.001). After SA change, VA at near and intermediate of both normal and diabetic presbyopic eyes improved. However, fewer diabetic eyes needed higher SA change than normal eyes (P = 0.03). The corresponding trends with change in VA at near and intermediate were also similar between the normal and diabetic eyes. Patient-specific modulation of ocular SA to improve near and intermediate VA in a large cohort of eyes was successful in improving VA, sometimes even distance VA.

Presbyopia and Ocular Conditions Causing Near Vision Impairment in Older Adults From the Brazilian Amazon Region.

PURPOSE: To investigate the prevalence and causes of near vision impairment (NVI) in a population of older adults from the Brazilian Amazon Region. DESIGN: Population-based cross-sectional study. METHODS: Cluster sampling was used in randomly selecting subjects 45 years of age and older from urban and rural areas of Parintins city, Brazil. Participants underwent ophthalmic examination, including uncorrected (UCNVA), presenting (PNVA), and best-corrected near visual acuity (BCNVA) from each eye; biomicroscopy; funduscopy; and subjective refraction, including testing with additional lenses for near vision optical correction. A principal cause for NVI was assigned by the ophthalmologist and presbyopia was defined as UCNVA ≤ 20/40 changing to > 20/40 with BCNVA. Free-of-charge glasses were provided for those in need. RESULTS: A total of 2384 subjects were enumerated and 2025 had reliable NVA measurements from both eyes. The prevalence of NVI in the better-seeing eye was 96.5% with UCNVA, decreasing to 81.1% with PNVA and to 20.5% with BCNVA. Presbyopia was the principal cause of NVI in 71.8%, followed by cataract (16.5%) and pterygium (2.5%), and was associated with younger age and high schooling. Glasses for near vision were prescribed and provided to 1414 (69.8%) participants. CONCLUSIONS: A high prevalence of NVI was detected even in those wearing glasses for near. Prescription and provision of low-cost reading glasses should be considered by Brazilian health authorities to address this easily and promptly correctable form of vision impairment.

The effectiveness of sphero-cylindrical correction at a short distance in presbyopic age patients with the first detected astigmatism.

OBJECTIVE: Introduction: The practical results of optical correction without considering the cylindrical component at close dictance do not always satisfy the patient in everyday visual activity. The aim: Compare the effect of sphero-cylindrical and spherical correction in presbyopic patients with the first detected astigmatism at a close distance work. PATIENTS AND METHODS: Materials and methods: The article presents the results of a survey of 43 patients (86 eyes) aged 38 to 59 years, on average 47 ± 0.8 years. In all patients, weak astigmatism with a cylinder (Cyl) of 0.5 D to 1.0 D was found. At the diagnostic stage all patients were offered a variant of spherical and sphero-cylindrical optical correction, the data we obtained formed two groups of comparison. RESULTS: Results: The average value of visual acuity at close distance (33 cm) in patients with spherical correction was better - 0.95 ± 0.06 (73 ± 1.4 optotypes) compared with spherocylindrical correction - 0.61 ± 0.02 (64 ± 0.8 optotypes). The mean distance (66 cm) is better in patients with sphero-cylindrical correction - 1,58 ± 0,01 (70 ± 0,02 optotypes) compared with spherical correction - 0,8 ± 0,05 (55 ± 1,0 optotypes). Also, when using spherical correction, the nearest point of clear vision was closer to the eye, compared with sphero-cylindrical correction, but the range of depth of vision at close range was greater when using sphero-cylindrical correction. CONCLUSION: Conclusions: Sphero-cylindrical correction at a distance of 66 cm gives a clearer visual acuity - 1.58 ± 0.01 (70 ± 0.02 optotypes) compared with spherical - 0.8 ± 0.05 (55± 1.0 optotypes).

Multifocal intraocular lenses: An overview.

Multifocal intraocular lenses are increasingly used in the management of pseudophakic presbyopia. After multifocal intraocular lens implantation, most patients do not need spectacles or contact lenses and are pleased with the result. Complications, however, may affect the patient's quality of life and level of satisfaction. Common problems with multifocal lenses are blurred vision and photic phenomena associated with residual ametropia, posterior capsule opacification, large pupil size, wavefront anomalies, dry eye, and lens decentration. The main reasons for these are failure to neuroadapt, lens dislocation, residual refractive error, and lens opacification. To avoid patient dissatisfaction after multifocal intraocular lens implantation, it is important to consider preoperatively the patient's lifestyle; perform an exhaustive examination including biometry, topography, and pupil reactivity; and explain the visual expectations and possible postoperative complications.

Short-term comparison between extended depth-of-focus prototype contact lenses and a commercially-available center-near multifocal / Comparación a corto plazo entre las lentes prototipo de profundidad de campo extendidas y las lentes multifocales de visión central-próxima, comercialmente disponibles

Purpose: To compare the visual performance of prototype contact lenses which extend depthof-focus (EDOF) by deliberate manipulation of multiple higher-order spherical aberration terms and a commercially-available center-near lens (AIR OPTIX Aqua Multifocal, AOMF). Methods: This was a prospective, cross-over, randomized, single-masked (participant), shortterm clinical trial where 52 participants (age 45-70 years) were stratified as low, medium or high presbyopes and wore EDOF and AOMF on different days. Objective measures comprised high and low contrast visual acuity (HCVA/LCVA, log MAR), and contrast sensitivity (log units) at 6 m; HCVA at 70 cm, 50 cm and 40 cm and stereopsis (seconds of arc) at 40 cm. HCVA at 70 cm, 50 cm and 40 cm were measured as «comfortable acuity» rather than conventional resolution acuity. Subjective measures comprised clarity-of-vision and ghosting at distance, intermediate and near, overall vision satisfaction and ocular comfort (1-10 numeric rating scale) and lens purchase (yes/no response). Statistical analysis included repeated measures ANOVA, paired t-tests and McNemar’s test. Results: Significant differences between lens types were independent of strata (p ≥ 0.119). EDOF was significantly better than AOMF for HCVA at 40 cm (0.42 ± 0.18 vs. 0.48 ± 0.22, p = 0.024), stereopsis (98 ± 88 vs. 141 ± 114, p < 0.001), clarity-of-vision at intermediate (8.5 ± 1.6 vs. 7.7 ± 1.9, p = 0.006) and near (7.3 ± 2.5 vs. 6.2 ± 2.5, p = 0.005), lack-of-ghosting (p = 0.012), overall vision satisfaction (7.5 ± 1.7 vs. 6.4 ± 2.2, p < 0.001) and ocular comfort (9.0 ± 1.0 vs. 8.3 ± 1.7, p = 0.002). Significantly more participants chose to only-purchase EDOF (33% vs. 6%, p = 0.003).). There were no significant differences between lens types for any objective measure at 6 m or clarity-of-vision at distance (p ≥ 0.356). Conclusions: EDOF provides better intermediate and near vision performance in presbyopes than AOMF with no difference for distance vision during short-term wear (AU)

Objetivo: Comparar el rendimiento visual de prototipos de lentes de contacto con las de profundidad de campo extendida (EDOF), mediante la manipulación deliberada de múltiples aberraciones esféricas de alto orden y las lentes de visión simultánea centro-cerca comercialmente disponibles (AIR OPTIX Aqua Multifocal, AOMF). Métodos: Ensayo clínico prospectivo, transversal, aleatorizado, con máscara única (participante), y a corto plazo, en el que se estratificó la presbicia de 52 participantes (de edades comprendidas entre 45 y 70 años) como baja, media o alta; dichos participantes utilizaron lentes EDOF y AOMF en días diferentes. Las mediciones objetivas incluyeron la agudeza visual de alto y bajo contraste (HCVA/LCVA, log MAR), y la sensibilidad al contraste (unidades log) a 6 m, HCVA a 70 cm, 50 cm y 40 cm, y estereopsis (segundos de arco) a 40 cm. La HCVA a 70 cm, 50 cm y 40 cm se midió como «agudeza de confort» en lugar de la agudeza de resolución convencional. Las mediciones subjetivas incluyeron la claridad de visión y la visión fantasma (ghosting) a distancia, la satisfacción con la visión general intermedia y lejana, el confort ocular (escala de clasificación numérica de 1a 10) y la adquisición de lentes de contacto (respuesta sí/no). El análisis estadístico incluyó la prueba ANOVA con medidas repetidas, la prueba de t pareada, y la prueba de McNemar. Resultados: La significación de las diferencias entre los tipos de lentes fue independiente de los estratos (p ≥ 0,119). Los resultados de EDOF fueron considerablemente mejores que los de AOMF en cuanto a HCVA a 40 cm (0,42 ± 0,18 frente a 0,48 ± 0,22, p = 0,024), estereopsis (98 ± 88 frente a 141 ± 114, p < 0,001), claridad de visión intermedia (8,5 ± 16 frente a 7,7 ± 1,9, p = 0,006) y próxima (7,3 ± 2,5 frente a 6,2 ± 2,5, p = 0,005), ausencia de visión fantasma (p = 0,012), satisfacción con la visión general (7,5 ± 1,7 frente a 6,4 ± 2,2, p < 0,001) y confort ocular (9,0 ± 1,0 frente a 8,3 ± 1,7, p = 0,002). Un número considerable de participantes optó por adquirir únicamente EDOF (33% frente al 6%, p = 0,003). No se produjeron diferencias significativas entre los dos tipos de lentes en relación a las mediciones objetivas a 6 m, ni a la claridad de visión lejana (p ≥ 0,356). Conclusiones: Las lentes EDOF proporcionaron un mejor rendimiento de la visión intermedia y próxima en pacientes con presbicia que las lentes AOMF, sin que se produjeran diferencias en cuanto a visión lejana con el uso a corto plazo (AU)

Visual complications in diabetes mellitus: beyond retinopathy.

Diabetic retinopathy is the most common cause of vision loss in people with diabetes mellitus; however, other causes of visual impairment/loss include other retinal and non-retinal visual problems, including glaucoma, age-related macular degeneration, non-arteritic anterior ischaemic optic neuropathy and cataracts. Additionally, when a person with diabetes complains of visual disturbance despite a visual acuity of 6/6, abnormalities in refraction, contrast sensitivity, straylight and amplitude of accommodation should be considered. We review and highlight these visual problems for physicians who manage people with diabetes to ensure timely referral and treatment to limit visual disability, which can have a significant impact on daily living, especially for those participating in sports and driving.

Effect of the Femtosecond Laser on an Intracorneal Inlay for Surgical Compensation of Presbyopia during Cataract Surgery: Scanning Electron Microscope Imaging.

PURPOSE: To investigate the effect of the femtosecond laser-assisted cataract surgery (FLACS) on porcine eyes implanted with a Kamra corneal inlay and to describe how the inlay may change the effect of the femtosecond laser on the lens. METHODS: FLACS was performed on six porcine eyes and a Kamra corneal inlay had been implanted, exploring the lens under the surgical microscope. Another Kamra corneal inlay was attached to the upper part of the transparent hemisphere used for calibration of the femtosecond laser. Capsulorhexis, arcuate incisions, and phacofragmentation were carried out. The Kamra corneal inlay was compared with a nontreated one using a scanning electron microscope (SEM), and the hemisphere was analyzed with a surgical microscope. RESULTS: Capsulorhexis and phacofragmentation were completed in all the porcine eyes, although accuracy to determine the exact effect on the lens was not possible to achieve. The effect of the femtosecond laser on the PMMA hemisphere through the Kamra corneal inlay showed the capsulorhexis was placed outside the outer margin of the inlay and a sharply sculpted fragmentation pattern with a three-dimensional (donut-shaped) annulus untreated beneath it. SEM images of the nontreated and the treated inlays were comparable. No ultrastructural changes were found in the treated Kamra corneal inlay. CONCLUSIONS: FLACS can be performed with a Kamra corneal inlay for surgical compensation of presbyopia without the risk of damaging the inlay. The Kamra corneal inlay acts as a screen that avoids the laser to reach the areas beneath its shadow, but not the exposed areas of the lens.

Effect of defocus on response time in different age groups: A pilot study / Efecto del desenfoque en el tiempo de respuesta en diferentes grupos de edad: estudio piloto

Purpose: To assess the response time associated with visual performance (VP) tasks in the presence of defocus in different presbyopic populations. Methods: 58 eyes between the ages of 35 and 50 years were studied. Subjects were categorized as pre-presbyopic (35-39 years), early-presbyopic (40-45 years), and mid-presbyopic (46-50 years). VP measurements obtained monocularly included distance and near high contrast (HC) and low contrast (LC) optotype recognition, and contrast threshold at 12cpd for different defocus magnitudes between 0D and 3D in 1D steps. Response time defined as the time taken to recognize and verbalize an optotype, was compared among different presbyopic age groups. Results: From 58 eyes, mean (SD) response time for high contrast distance visual acuity for 0D through 3D ranged between 1.48 (0.23) and 1.87 (0.31)s, whereas low contrast distance visual acuity ranged between 1.5 (0.22) and 2.09 (0.49)s. Mean response time for high contrast near visual acuity for 0D through 3D ranged between 1.56 (0.19) and 2.23 (0.45)s. However, for low contrast near visual acuity it ranged between 1.75 (0.32) and 2.71 (0.94)s. Mean (SD) response time for 12cpd ranged between 2.11 (0.50) and 5.72 (1.09)s. ANOVA revealed a significant difference in response time for distance, near visual acuity and contrast sensitivity as a function of defocus for different age groups. Conclusions: Response time is increased in the presence of increasing defocus for both distance and near visual acuity and could impact on performance for critical tasks. Full correction of visual acuity at distance and near in presbyopes is warranted always (AU)

Objetivo: Evaluar el tiempo de respuesta asociado a las tareas del desempeño visual (DV) en presencia de desenfoque, en diferentes poblaciones présbitas. Métodos: Se estudiaron 58 ojos de personas en edades comprendidas entre 35 y 50 años. Se clasificó a los sujetos conforme a las siguientes categorías: pre-presbicia (35-39 años), presbicia temprana (40-45 años), y presbicia media (46-50 años). Las mediciones del desempeño visual obtenidas de forma monocular incluyeron el reconocimiento de optotipos cercanos y lejanos de alto y bajo contraste y el umbral de contraste a 12cpd para las diferentes magnitudes de desenfoque, entre 0D y 3D, a intervalos de 1D. El tiempo de respuesta es el tiempo empleado en reconocer y verbalizar un optotipo, y se comparó entre los diferentes grupos de edad de los individuos présbitas. Resultados: De los 58 ojos, el tiempo de respuesta media (DE) para la agudeza visual de la distancia a alto contraste, entre 0D y 3D, osciló entre 1,48 (0,23) y 1,87 (0,31) segundos, mientras que la agudeza visual de la distancia a bajo contraste osciló entre 1,5 (0,22) y 2,09 (0,49) segundos. El tiempo de respuesta media para la agudeza visual cercana de alto contraste entre 0D y 3D osciló entre 1,56 (0,19) y 2,23 (0,45) segundos. Sin embargo para la agudeza visual cercana de bajo contraste osciló entre 1,75 (0,32) y 2,71 (0,94) segundos. El tiempo de respuesta media (DE) para 12cpd osciló entre 2,11 (0,50) y 5,72 (1,09) segundos. ANOVA reveló una diferencia significativa en cuanto al tiempo de respuesta para la distancia, agudeza visual cercana y sensibilidad de contraste como función del desenfoque para los diferentes grupos de edad. Conclusiones: El tiempo de respuesta se eleva al incrementarse el desenfoque en la agudeza visual lejana y cercana, pudiendo repercutir sobre el desempeño de ciertas tareas esenciales. La corrección plena de la agudeza visual cercana y lejana en individuos présbitas debe de ser siempre garantizada (AU)

Combined Cataract and Refractive Corneal Inlay Implantation Surgery: Comparison of Three Techniques.

PURPOSE: To compare clinical outcomes of three different techniques of combined cataract and Presbia Flexivue Microlens refractive corneal inlay (Presbia Coöperatief U.A., Amsterdam, Netherlands) implantation surgery for presbyopia compensation over a 12-month follow-up. METHODS: In this comparative pilot study, 15 patients with bilateral cataract were allocated to one of three groups with a different combination of surgical steps (cataract surgery, intrastromal pocket creation, and inlay implantation). In the three-step group, the intracorneal pocket was created in the non-dominant eye, bilateral cataract surgery was performed 3 months later, and the intracorneal inlay was inserted 3 months after that. In the two-step at 3 days group, bilateral cataract surgery was performed 3 days after pocket creation and inlay implantation in the non-dominant eye. In the two-step at 3 months group, the pocket creation and the inlay implantation were performed in the non-dominant eye 3 months after bilateral cataract surgery. Visual, refractive, and contrast sensitivity outcomes were evaluated and compared between the three groups. RESULTS: Twelve months after the inlay implantation, mean monocular uncorrected distance visual acuity was 20/32 in the three-step group, 20/32 in the two-step at 3 days group, and 20/25 in the two-step at 3 months group. Achieved mean monocular uncorrected near visual acuity was similar in the three groups (20/25). The visual and refractive outcomes did not show significant differences between groups. Contrast sensitivity was similar between groups under mesopic and photopic conditions. No intraoperative or postoperative complications were observed. CONCLUSIONS: Clinical outcomes of three different techniques of combined cataract surgery and refractive corneal inlay implantation had no apparent differences between them. The corneal inlay provided excellent near vision acuity, with high patient satisfaction and a high spectacle independence rate after cataract surgery. [J Refract Surg. 2016;32(5):318-325.].