Development and Valuation of a Preference-Weighted Measure in Age-Related Macular Degeneration From the Vision Impairment in Low Luminance Questionnaire: A MACUSTAR Report.

OBJECTIVES: This study generates VILL-UI (Vision Impairment in Low Luminance - Utility Index), a preference-weighted measure (PWM) derived from the VILL-33 measure for use in patients with age-related macular degeneration (AMD) and valued to generate United Kingdom and German preference weights. METHODS: A PWM consists of a classification system to describe health and utility values for every state described by the classification. The classification was derived using existing data collected as part of the MACUSTAR study, a low-interventional study on AMD, conducted at 20 clinical sites across Europe. Items were selected using psychometric and Rasch analyses, published criteria around PWM suitability, alongside instrument developer views and concept elicitation work that informed VILL-33 development. An online discrete choice experiment (DCE) with duration of the health state was conducted with the United Kingdom and German public. Responses were modeled to generate utility values for all possible health states. RESULTS: The classification system has 5 items across the 3 domains of VILL-33: reading and accessing information, mobility and safety, and emotional well-being. The DCE samples (United Kingdom: n = 1004, Germany: n = 1008) are broadly representative and demonstrate good understanding of the tasks. The final DCE analyses produce logically consistent and significant coefficients. CONCLUSIONS: This study enables responses to VILL-33 to be directly used to inform economic evaluation in AMD. The elicitation of preferences from both United Kingdom and Germany enables greater application of VILL-UI for economic evaluation throughout Europe. VILL-UI fills a gap in AMD in which generic preference-weighted measures typically lack sensitivity.

Mental health and visual acuity in patients with age-related macular degeneration.

BACKGROUND: Visual acuity (VA) loss has been associated with depression in patients with age-related macular degeneration (AMD). However, previous studies did not incorporate subgroups of AMD when correlating VA and mental health. The goal of this study was to describe the relationship between VA and mental health questions in patients with different classifications of AMD, and to identify associations of mental health subscale scores. METHODS: AMD patients classified by multi-modal imaging were recruited into an AMD registry. Habitual VA was obtained by ophthalmic technicians using the Snellen VA at distance. At enrollment, patients completed the NEI-VFQ-25, which includes 25 questions regarding the patient's visual functionality. Median with interquartile-range (IQR) scores on the mental health subscale of the VFQ were calculated by AMD classification and VA groups. Univariate and multivariable general linear models were used to estimate associations between mental health scores and variables of interest. RESULTS: Eight hundred seventy-five patients were included in the study. Patients with bilateral geographic atrophy (GA) or bilateral GA and neovascular (NV) AMD scored lowest on the mental health subscales with a median (IQR) of 58.2 (38-88) and 59.3 (38-88). When stratified by VA, patients with a habitual VA of 20/200 or worse scored the lowest on mental health subscales scores: median of 43.8 (IQR: 31-62). Patients with a VA of 20/20 scored the highest: 87.5 (IQR: 81-94). Habitual VA of the better- and worse-seeing eye and AMD classification were significantly associated with mental health subscale scores (all p < 0.0001 in both the univariate and multivariable analysis, except the VA of the worse-seeing eye in multivariable model p = 0.027). Patients enrolled during the COVID pandemic had mental health scores that were 2.7 points lower than prior to the pandemic, but this difference was not significant in univariate (p = 0.300) or multivariable analysis (p = 0.202). CONCLUSION: There is a significant association between mental health questionnaire scores and AMD classification, as well as VA in both the better and worse-seeing eyes in patients with AMD. It is important for clinicians to recognize feelings of worry/ frustration in these patients, so they can be appropriately referred, screened, and treated for mental health problems.

Prevention of depression in adults with long-term physical conditions.

BACKGROUND: Major depression is one of the world's leading causes of disability in adults with long-term physical conditions compared to those without physical illness. This co-morbidity is associated with a negative prognosis in terms of increased morbidity and mortality rates, increased healthcare costs, decreased adherence to treatment regimens, and a substantial decline in quality of life. Therefore, preventing the onset of depressive episodes in adults with long-term physical conditions should be a global healthcare aim. In this review, primary or tertiary (in cases of preventing recurrences in those with a history of depression) prevention are the focus. While primary prevention aims at preventing the onset of depression, tertiary prevention comprises both preventing recurrences and prohibiting relapses. Tertiary prevention aims to address a depressive episode that might still be present, is about to subside, or has recently resolved. We included tertiary prevention in the case where the focus was preventing the onset of depression in those with a history of depression (preventing recurrences) but excluded it if it specifically focused on maintaining an condition or implementing rehabilitation services (relapse prevention). Secondary prevention of depression seeks to prevent the progression of depressive symptoms by early detection and treatment and may therefore be considered a 'treatment,' rather than prevention. We therefore exclude the whole spectrum of secondary prevention. OBJECTIVES: To assess the effectiveness, acceptability and tolerability of psychological or pharmacological interventions, in comparison to control conditions, in preventing depression in adults with long-term physical conditions; either before first ever onset of depressive symptoms (i.e. primary prevention) or before first onset of depressive symptoms in patients with a history of depression (i.e. tertiary prevention). SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO and two trials registries, up to 6 February 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of preventive psychological or pharmacological interventions, specifically targeting incidence of depression in comparison to treatment as usual (TAU), waiting list, attention/psychological placebo, or placebo. Participants had to be age 18 years or older, with at least one long-term physical condition, and no diagnosis of major depression at baseline (primary prevention). In addition, we included studies comprising mixed samples of patients with and without a history of depression, which explored tertiary prevention of recurrent depression. We excluded other tertiary prevention studies. We also excluded secondary preventive interventions. Primary outcomes included incidence of depression, tolerability, and acceptability. Secondary outcomes included severity of depression, cost-effectiveness and cost-utility. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 11 RCTs, with one trial on psychological interventions, and 10 trials on pharmacological interventions. Data analyses on the psychological intervention (problem-solving therapy compared to TAU) included 194 participants with age-related macular degeneration. Data analyses on pharmacological interventions included 837 participants comparing citalopram (one trial), escitalopram (three trials), a mixed sample of fluoxetine/nortriptyline (one trial), melatonin (one trial), milnacipran (one trial), and sertraline (three trials), each to placebo. Included types of long-term physical conditions were acute coronary syndrome (one trial), breast cancer (one trial), head and neck cancer (two trials), stroke (five trials), and traumatic brain injury (one trial). Psychological interventions Very low-certainty evidence of one study suggests that problem solving therapy may be slightly more effective than TAU in preventing the incidence of depression, immediately post-intervention (odds ratio (OR) 0.43, 95% confidence interval (CI) 0.20 to 0.95; 194 participants). However, there may be little to no difference between groups at six months follow-up (OR 0.71, 95% CI 0.36 to 1.38; 190 participants; one study; very low-certainty evidence). No data were available regarding incidence of depression after six months. Regarding acceptability (drop-outs due to any cause), slightly fewer drop-outs occurred in the TAU group immediately post-intervention (OR 5.21, 95% CI 1.11 to 24.40; 206 participants; low-certainty evidence). After six months, however, the groups did not differ (OR 1.67, 95% CI 0.58 to 4.77; 206 participants; low-certainty evidence). This study did not measure tolerability. Pharmacological interventions Post-intervention, compared to placebo, antidepressants may be beneficial in preventing depression in adults with different types of long-term physical conditions, but the evidence is very uncertain (OR 0.31, 95% CI 0.20 to 0.49; 814 participants; nine studies; I2 =0%; very low-certainty evidence). There may be little to no difference between groups both immediately and at six months follow-up (OR 0.44, 95% CI 0.08 to 2.46; 23 participants; one study; very low-certainty evidence) as well as at six to 12 months follow-up (OR 0.81, 95% CI 0.23 to 2.82; 233 participants; three studies; I2 = 49%; very low-certainty evidence). There was very low-certainty evidence from five studies regarding the tolerability of the pharmacological intervention. A total of 669 adverse events were observed in 316 participants from the pharmacological intervention group, and 610 adverse events from 311 participants in the placebo group. There was very low-certainty evidence that drop-outs due to adverse events may be less frequent in the placebo group (OR 2.05, 95% CI 1.07 to 3.89; 561 participants; five studies; I2 = 0%). There was also very low-certainty evidence that drop-outs due to any cause may not differ between groups either post-intervention (OR 1.13, 95% CI 0.73 to 1.73; 962 participants; nine studies; I2 = 28%), or at six to 12 months (OR 1.13, 95% CI 0.69 to 1.86; 327 participants; three studies; I2 = 0%). AUTHORS' CONCLUSIONS: Based on evidence of very low certainty, our results may indicate the benefit of pharmacological interventions, during or directly after preventive treatment. Few trials examined short-term outcomes up to six months, nor the follow-up effects at six to 12 months, with studies suffering from great numbers of drop-outs and inconclusive results. Generalisation of results is limited as study populations and treatment regimes were very heterogeneous. Based on the results of this review, we conclude that for adults with long-term physical conditions, there is only very uncertain evidence regarding the implementation of any primary preventive interventions (psychological/pharmacological) for depression.

Perspectives of people with late age-related macular degeneration on mental health and mental wellbeing programmes: a qualitative study.

PURPOSE: People with age-related macular degeneration (AMD) experience high rates of depression, but rarely engage in or have access to tailored mental wellbeing programmes. This qualitative study investigated the perspectives of those primarily with late AMD on mental health and mental wellbeing programmes. METHODS: Twenty-eight people with late AMD in at least one eye, and one person with early AMD in both eyes, aged 56-87 years (mean age 78 years) attending a private eye clinic between December 2019 and January 2020 in Sydney, New South Wales, Australia, participated. Individual semi-structured interviews were conducted and analysed deductively using content analysis, following the individual level factors for health promotion interventions in the behaviour change wheel: Capability (Physical & Psychological), Opportunity (Physical & Social), and Motivation (Reflective & Automatic). RESULTS: Six major themes were identified: Capability: (1) Impact of vision loss on mobility and leisure pursuits; (2) Adjustment to living with vision loss; Opportunity: (3) Program considerations for those with AMD; (4) Stigma and self-perception of vision loss and mental health; Motivation: (5) Accumulation of vision-related issues as a barrier to participation; (6) Examples of others living with vision loss. General personal factors relevant to delivery of a programme in this age group were also identified: Comorbidities; Limitations using technology; Isolation; Financial concerns and Beliefs that undesired effects of aging are inevitable. CONCLUSIONS: Complex individual, environmental and social factors influence the perspectives of people with late AMD on mental health, and potential participation in mental wellbeing programmes. These factors should be considered when developing and implementing mental wellbeing programmes to improve the emotional and functional rehabilitation outcomes for people with AMD.

Levels of self-reported and objective physical activity in individuals with age-related macular degeneration.

BACKGROUND: Self-report in people with age-related macular degeneration (AMD) shows that they lead less active lifestyles. Physical activity is important as it has been shown to improve quality of life, reduce co-morbidity and also slow down the progression of AMD. Self-reported measures of physical activity are prone to subjective biases and therefore less accurate in quantifying physical activity. This study compared self-reported and objective (accelerometer-based) physical activity levels and patterns in older adults with AMD. METHODS: Data were collected in 11 AMD subjects with binocular vision loss (aged 76 ± 7 years), 10 AMD subjects with good binocular vision (aged 76 ± 7 years), and 11 controls (aged 70 ± 4 years). Binocular vision was established using visual acuity score. Contrast sensitivity and visual fields were also measured. Self-reported sedentary behaviour and moderate-to-vigorous physical activity (MVPA) was assessed using the Global Physical Activity Questionnaire. Objective measurements were obtained with an Actigraph GT3X accelerometer being worn for seven consecutive days on the hip. The objective physical activity measures were sedentary behaviour, light physical activity, MVPA, and step count. RESULTS: Objectively measured MVPA was 33-34% higher for controls compared to both AMD groups (p < 0.05). There were no group differences for any of the other objectively measured physical activity variables and self-reported physical activity variables were also not significantly different (all p > 0.05). Comparing the objective with the self-report physical activity measure showed that all groups under-reported their sedentary behaviour and MVPA, but controls under-reported their MVPA more than both AMD groups (p < 0.05). Weak to moderate correlations were observed between the severity of vision loss and objective physical activity measures (all - 0.413 ≥ r ≤ 0.443), while correlations for self-reported physical activity measures were less strong (all - 0.303 ≥ r ≤ 0.114). CONCLUSIONS: People with AMD, irrespective of whether they were vision impaired, were better able to estimate the time spent in MVPA compared to controls. However, objectively measured MVPA, was higher in controls than AMD subjects. Although clinicians may use self-report to monitor the compliance of AMD subjects with any prescribed exercise programs, they should be aware that a valid comparison with healthy controls can only be made when MVPA is objectively measured.

Randomized Controlled Trial of a Spectacle Lens for Macular Degeneration.

SIGNIFICANCE: E-Scoop, a spectacle lens, provides no clinically relevant improvements on quality of life, visual acuity, and contrast sensitivity for patients with AMD. Because patients' burden is high and therapeutic options are scarce, the incentive to develop effective vision rehabilitation interventions remains. PURPOSE: Patients with AMD experience low quality of life due to vision loss, despite angiogenesis inhibitor interventions that slow down progression for some patients. E-Scoop, which includes low-power prisms, 6% magnification, yellow tint, and antireflection coating, might aid in daily activities by improving distance viewing. Separately, these features have little proven effectiveness. E-Scoop has not been formally tested. This study aimed to determine the impact of E-Scoop on quality of life and the effect on visual acuity and contrast sensitivity. METHODS: In this randomized controlled, open-label trial, 190 of 226 eligible patients were included. The primary outcome was quality of life measured with the 25-item National Eye Institute Visual Function Questionnaire. Secondary outcomes were visual acuity and contrast sensitivity. The follow-up for quality of life was after 6 weeks for controls and after 3 weeks of use for E-Scoop wearers. The visual measures were repeated after 6 weeks, with optimal refractive correction, with and without E-Scoop. RESULTS: Randomization resulted in 99 E-Scoop and 86 control group patients for intention-to-treat analysis. No differential change was found between the E-Scoop and control groups on the 25-item National Eye Institute Visual Function Questionnaire using Rasch analysis (Cohen d = -0.07, P = .53). Statistically significant but small effects were found in favor of E-Scoop on binocular visual acuity (mean difference, 0.05 logMAR [2.5 letters, P < .001]) and contrast sensitivity (mean difference, 0.10 logCS [2 letters, P < .001]). CONCLUSIONS: No effect of E-Scoop on quality of life was found. E-Scoop showed effects that were statistically significant, although not clinically meaningful and within typical variability, on visual measures.

A comparative study of depressive symptomatology among cataract and age-related macular degeneration patients with impaired vision.

Vision impairment remains an important cause of disability with the leading being age-related cataract (ARC) and age-related macular degeneration (ARMD) with depression symptoms often reported in vision impairment. This is a cross-sectional survey of two groups of fifty patients with ARC and ARMD and no prior psychiatric history on depressive symptomatology. Results indicate that ARMD patients scored higher on the BDI-II than ARC patients, in line with their poorer prognosis. Female patients with ARMD, living alone, with a higher number of other comorbid health issues, are more likely to have more depressive symptomatology. ARMD patients scored higher in the items related to pessimism for the future, feelings of past failure and feelings of self-dislike. There is a need for liaison psychiatry services to be readily available in patients with suspected ARC and ARMD coming forward with substantial vision loss. ARMD patients in particular tend to be more pessimistic and blame themselves for the progression of their disease. This should be taken into consideration with patient education on the causes of the disease and more effort should be undertaken to instill hope. The impact of vision loss on psychic status is related to disease prognosis and not only current state.

Psychological and Psychosocial Interventions for Depression and Anxiety in Patients With Age-Related Macular Degeneration: A Systematic Review.

OBJECTIVE: To review the current literature on psychosocial and psychological interventions to prevent and treat depression and anxiety in patients with age-related macular degeneration (AMD). METHODS: The authors conducted a systematic review of literature evaluating psychosocial and psychological interventions for depression and anxiety in patients with AMD. Primary searches of PubMed, Cochrane library, EMBASE, Global Health, Web of Science, EBSCO, and Science Direct were conducted to include all articles published up to April 21, 2018. RESULTS: Of a total of 398 citations retrieved, the authors selected 12 eligible studies published between 2002 and 2016. The authors found nine randomized controlled trials (RCT), and three non-randomized intervention (NRI) studies. RCT studies suggested that interventions using group self-management techniques and individual behavioral activation plus low vision rehabilitation can be effective to treat and prevent depression in patients with AMD, and one study suggested that a stepped-care intervention using cognitive-behavioral techniques can be effective to manage anxiety and depression over time. NRI studies highlighted a positive effect of self-help and emotion-focused interventions to reduce depression. CONCLUSION: Clinical practice with patients with AMD can rely on some tailored cognitive-behavioral therapeutic protocols to improve patients' mental health, but further clinical trials will generate the necessary evidence-based knowledge to improve those therapeutic techniques and offer additional tailored interventions for patients with AMD.

Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) in a Norwegian population of patients with neovascular age-related macular degeneration compared to a control population.

BACKGROUND: Although visual acuity and optical coherence tomography (OCT) are most widely used as outcomes in treatment of neovascular age-related Macular Degeneration (nAMD), patient reported outcome measures are increasingly recognized. National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) was developed to capture the perceived visual function. Yet, evidence of psychometric performance in the target population is required. The aim of this study was to examine the psychometric properties of NEI-VFQ 25 in a Norwegian cohort of newly diagnosed nAMD patients followed with a Treat and Extend (T/E) protocol. METHODS: Patients receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection treatment according to a T/E protocol completed a Norwegian translation of NEI-VFQ 25, EuroQoL Health Questionnaire (EQ-5D), and Patient acceptable symptom state (PASS 5) at baseline, 3, 6 and 12 months. In addition, a control population completed the same questionnaires. Visual acuity was assessed with LogMar for best/treated eye. Validity testing comprised face validity by a 0-10 numeric rating scale about relevance of NEI-VFQ 25 as well as regression analyses and correlations between NEI-VFQ 25 and other relevant variables. Reliability was examined with Intraclass Correlation Coefficient (ICC) and Cronbach's alpha for internal consistency were performed. Responsiveness, discriminatory power and predictive value were also explored. RESULTS: Number of respondents at baseline, after 3, 6 and 12 months was 197, 186, 176 and 168, respectively. The control population comprised 26 individuals. Face validity of NEI-VFQ 25 had a mean (SD) of 7.8 (1.7) (n = 84). NEI-VFQ was significantly correlated to visual acuity and PASS 5 as well as EQ-5D at baseline. Reliability (ICC) of the overall and sub scores for the patients/controls ranged from 0.49-0.97/0.59-0.97. Cronbach's alpha was 0.61-0.85. Discriminatory power was confirmed by significant differences of the overall score between controls and patients (P < 0.001). NEI-VFQ 25 indicates responsiveness showing overall score improved significantly (P ≤ 0.001) from baseline to 3 months. NEI-VFQ 25, general health and visual acuity at baseline were the strongest predictors for how patients reported vision after 6 months follow-up. CONCLUSION: NEI-VFQ 25 showed acceptable psychometric performance, which supports that the Norwegian version can be used to monitor patients treated for nAMD.

How Do Patients Respond to Genetic Testing for Age-related Macular Degeneration?

SIGNIFICANCE: The American Academy of Ophthalmology currently recommends against routine genetic testing for complex diseases such as age-related macular degeneration (AMD). The results of this study demonstrate that patients are very interested in predictive genetic testing for AMD, find the information useful, and make behavioral changes as a result of the information. PURPOSE: The goal of this project was to conduct a pilot AMD genomic medicine study. METHODS: Eligible patients were aged 50 to 65 years with no personal history of AMD. DNA samples were genotyped for five single-nucleotide polymorphisms (SNPs) in the CFH gene, one SNP in the ARMS-2 gene, one SNP in the C3 gene, and one SNP in the mitochondrial ND2 gene. A risk score was calculated utilizing a model based on odds ratios, lifetime risk of advanced AMD and known population prevalence of genotype, haplotype, and smoking risk. The study optometrist provided the patient's risk score and counseling for personal protective behaviors. Telephone interviews were conducted 1 to 3 months after the counseling visit. RESULTS: One hundred one subjects (85%) participated in the genetic testing; 78 (77.2%) were female. Follow-up interviews were conducted with 94 participants (93.1%). More than half (n = 48) of the participants said that they were motivated to participate in the study because they had a family member with AMD or another eye or genetic disorder. Despite low risk levels, many participants reported making changes as a result of the genetic testing. Twenty-seven people reported making specific changes, including wearing sunglasses and brimmed hat and taking vitamin supplements. Another 16 people said that they were already doing the recommended activities, including wearing glasses, quitting smoking, and/or taking vitamins. CONCLUSIONS: Interest in genetic testing for future risk of AMD was high in this population and resulted in support to continue current health behaviors or incentive to improve behaviors related to eye health.

Reliability, validity and responsiveness of the Greek MacDQoL individualized measure of the impact of macular degeneration on quality of life.

PURPOSE: To assess the psychometric properties of the Greek Macular Disease-Dependent Quality of Life Questionnaire (MacDQoL). METHODS: The MacDQoL was translated in Greek and administered to 191 patients with neovascular age-related macular degeneration (AMD). To assess validity, all patients completed the Greek SF-12 health survey and underwent vision measurements. For test-retest reliability, a subset of twenty participants completed the MacDQoL twice, 2 weeks apart. Responsiveness was assessed on 102 patients who completed the MacDQoL at a follow-up visit, 1 year later. Rasch analysis was used to assess the Greek MacDQoL's response category functioning, precision, unidimensionality, targeting and differential item functioning. RESULTS: Internal and test-retest reliability of the average weighted impact (AWI) was 0.952 and 0.97, respectively. Test-retest reliability of MacDQoL items ranged from 0.78 to 0.99. Principal component analysis revealed three subscales (activities, embarrassment and family life), which were also confirmed by confirmatory factor analysis. Rasch analysis revealed poor functionality of response categories and that was resolved by collapsing response categories and using the impairment scores only. In terms of convergent validity, the AWI and revised MacDQoL scales showed significant correlations with SF-12 summary scales (ρ = 0.21-0.30) and vision assessments (ρ = 0.31-0.46). Poorer AMD-related QoL at 1-year follow-up was associated with deterioration in distance visual acuity and worse eye near visual acuity. CONCLUSIONS: The Greek MacDQoL is a reliable, valid and sensitive to change in vision instrument for assessing AMD patients' perceptions of QoL. However, Rasch analysis revealed that its multiplicative rating scale is flawed. Scientific measurement was restored with a number of revisions to the questionnaire.

A population study of correlates of social participation in older adults with age-related vision loss.

OBJECTIVE: To examine personal characteristics, disease-related impairment variables, activity limitations, and environmental factors as correlates of social participation in older adults with vision loss guided by the World Health Organization's International Classification of Functioning, Disability and Health Model. DESIGN: Baseline data of a larger longitudinal study. SETTING: Community-based vision rehabilitation agency. SUBJECTS: A total of 364 older adults with significant vision impairment due to age-related macular degeneration. MAIN MEASURES: In-person interviews assessing social participation (i.e. frequency of social support contacts, social/leisure challenges faced due to vision loss, and of social support provided to others) and hypothesized correlates (e.g. visual acuity test, Functional Vision Screening Questionnaire, ratings of attachment to house and neighborhood, environmental modifications in home). RESULTS: Regression analyses showed that indicators of physical, social, and mental functioning (e.g. better visual function, fewer difficulties with instrumental activities of daily living, fewer depressive symptoms) were positively related to social participation indicators (greater social contacts, less challenges in social/leisure domains, and providing more support to others). Environmental factors also emerged as independent correlates of social participation indicators when functional variables were controlled. That is, participants reporting higher attachment to their neighborhood and better income adequacy reported having more social contacts; and those implementing more environmental strategies were more likely to report greater challenges in social and leisure domains. Better income adequacy and living with more people were related to providing more social support to others. CONCLUSION: Environmental variables may play a role in the social participation of older adults with age-related macular degeneration.

Measurement of Perceived Stress in Age-Related Macular Degeneration.

PURPOSE: To validate the Perceived Stress Scale (PSS) in patients with age-related macular degeneration (AMD) using Rasch analysis. METHODS: Study participants with AMD were recruited from the retina service of the Department of Ophthalmology at the Ohio State University during clinical visits for treatment or observation. Visual acuity with habitual distance correction was assessed. A 10-item version of the PSS was administered in large print or by reading the items to the patient. Rasch analysis was used to investigate the measurement properties of the PSS, including fit to the model, ability to separate between people with different levels of perceived stress, category response structure performance, and unidimensionality. RESULTS: A total of 137 patients with a diagnosis of AMD were enrolled. The mean (±SD) age of participants was 82 ± 9 years. Fifty-four percent were female. Median Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity of the better eye was 65 letters (Snellen 20/50), with a range of approximately 20/800 to 20/15. Forty-seven percent of participants were receiving an anti-VEGF injection on the day of the study visit. The response category structure was appropriate. One item, "How often have you felt confident in your ability to handle your personal problems?" was removed due to poor fit statistics. The remaining nine items showed good fit to the model, acceptable measurement precision as assessed by the Rasch person separation statistic, and unidimensionality. There was some evidence of differential item functioning by age and visual acuity. CONCLUSIONS: The Perceived Stress Scale demonstrated acceptable measurement properties and may be useful for the measurement of perceived stress in patients with AMD.

Vision-related quality of life in patients receiving intravitreal ranibizumab injections in routine clinical practice: baseline data from the German OCEAN study.

BACKGROUND: Vision-related quality of life (vrQoL) is advancing more and more into the focus of interest in ophthalmological clinical research. However, to date only little information is available about vrQoL from large non-interventional studies in terms of "real-world evidence". The purpose of this investigation was to describe baseline VFQ-25 visual function scores, to evaluate whether they differ from previous phase III clinical trials, to determine which contributing factors (e.g. indication, age, gender) affect VFQ-25 scores and to identify its impact on driving. METHODS: The non-interventional OCEAN study (Observation of treatment patterns with LuCEntis and real life ophthalmic monitoring, including optional OCT in Approved iNdications) is the largest ophthalmic study conducted in Germany, to evaluate the real world situation of patients treated with ranibizumab (NCT02194803). The NEI-VFQ-25 questionnaire was conducted at baseline, months 4, 12 and 24. Descriptive statistics was used to analyse the baseline data. ANOVA was performed to evaluate the impact of various contributing factors on composite and selected subscale scores. RESULTS: Overall, 4844 (84.1 %) of all 5760 OCEAN patients completed the VFQ-25 questionnaire at baseline. Thereof, 3414 treatment-naïve patients were further analysed. Overall, the VFQ subscore general health was most affected by the ocular disease, followed by general vision. No major differences were detected in comparison to corresponding VFQ-25 scores of previous phase III clinical trials, except in DME patients, or with respect to possible contributing factors. A tendency towards a more decreased VFQ-25 composite score was observed for nAMD, for elderly patients ≥75 years of age, for female patients, for patients with low baseline visual acuity (VA; <50 letters) and for those with statutory health insurance. Indication, age, gender, baseline VA (all p <0.01) and the interaction of age and indication, as well as baseline VA and indication (p <0.01 each) had a significant impact on composite, general vision and distance vision scores (ANOVA). About 10 % of patients gave up driving due to eyesight issues. CONCLUSIONS: The knowledge of a patient's subjective disease burden is crucial to understanding anxieties and mental anguish. Additionally, the understanding of the impact of various contributing factors on the VFQ-25 scores and the extent to which they can be influenced help to optimize patient care. It demonstrates the need for medical and mental support by all medical staff, to encourage patients' compliance with a comprehensive anti-VEGF therapy, to increase BCVA and, consecutively, VFQ-25 scores. TRIAL REGISTRATION: NCT02194803.

Generic and disease-specific estimates of quality of life in macular degeneration: mapping the MacDQoL onto the EQ-5D-3L.

PURPOSE: The macular degeneration quality of life (MacDQoL) instrument is a validated condition-specific measure of quality of life in patients with macular degeneration. This paper presents the first mapping algorithm to predict EQ-5D from responses to the MacDQoL instrument. METHODS: Responses to the MacDQoL and EQ-5D-3L instruments from 482 patients were collected from the IVAN multicentre trial of two alternative drug treatments for neovascular age-related macular degeneration. Regression specifications were estimated using OLS, censored least absolute deviation, Tobit and two-part models. Their predictive performance was assessed using mean squared error. An internal validation sample based on a random selection of 25 % of patients was used to assess the performance of the model estimated on the remaining 75 % of patients. RESULTS: A two-part model had the best predictive performance on the full sample. The covariates of this model include responses and weighted impact scores for all 23 condition-specific domains of the MacDQoL, and responses to a general MacDQoL quality of life question. The selected models were successful at predicting means and standard deviations of target populations, but prediction is weaker at the upper and lower extremes of the EQ-5D-3L distribution. CONCLUSION: The mapping algorithms provide a means of predicting EQ-5D-3L index scores from MacDQoL scores, and could facilitate cost-effectiveness analyses when the latter but not the former are available to researchers. Further validation of the performance of the algorithms using external data would provide a means of establishing the robustness of the algorithms.

Patient-reported utilities in bilateral visual impairment from amblyopia and age-related macular degeneration.

BACKGROUND: Utility of visual impairment caused by amblyopia is important for the cost-effectiveness of screening for amblyopia (lazy eye, prevalence 3-3.5 %). We previously measured decrease of utility in 35-year-old persons with unilateral persistent amblyopia. The current observational case-control study aimed to measure loss of utility in patients with amblyopia with recent decrease of vision in their better eye. As these patients are rare, the sample was supplemented by patients with bilateral age-related macular degeneration with similar decrease of vision. METHODS: From our out-patient department, two groups of patients with recent deterioration to bilateral visual acuity less than Snellen 0.5 (bilateral visual impairment, BVI) were recruited, with either persistent amblyopia and age-related macular degeneration (AMB + AMD), or with bilateral age-related macular degeneration (BAMD). To measure utility, the time trade-off method and the standard gamble method were applied through interviews. Correlations were sought between utility values and visual acuity, age and Visual Function Questionnaire-25 scores. RESULTS: Seventeen AMB + AMD patients (mean age 72.9 years), and 63 BAMD patients (mean age 79.6 years) were included in the study. Among AMB + AMD, 80 % were willing to trade lifetime in exchange for cure. The overall mean time trade-off utility was 0.925. Among BAMD, 75 % were willing to trade, utility was 0.917. Among AMB + AMD, 38 % accepted risk of death in exchange for cure, overall mean standard gamble utility was 0.999. Among BAMD, 49 % accepted risk of death, utility was 0.998. Utility was not related to visual acuity but it was to age (p = 0.02). CONCLUSION: Elderly patients with BVI, caused by persistent amblyopia and age-related macular degeneration (AMD) or by bilateral AMD, had an approximately 8 % loss of TTO utility. Notably, the 8 % loss in elderly with BVI differs little from the 3.7 % loss we found previously in 35-year-old persons with unilateral amblyopia with good vision in the other eye. The moderate impact of BVI in senescence could be explained by adaptation, comorbidity, avoidance of risk and a changed percept of cure.

Cost-Utility Analyses of Cataract Surgery in Advanced Age-Related Macular Degeneration.

PURPOSE: To explore the cost-utility of cataract surgery in patients with advanced age-related macular degeneration (AMD). METHODS: Patients who were diagnosed as having and treated for age-related cataract and with a history of advanced AMD at the Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University, were included in the study. All of the participants underwent successful phacoemulsification with foldable posterior chamber intraocular lens implantation under retrobulbar anesthesia. Best-corrected visual acuity (BCVA) and utility value elicited by time trade-off method from patients at 3-month postoperative time were compared with those before surgery. Quality-adjusted life years (QALYs) gained in a lifetime were calculated at a 3% annual discounted rate. Costs per QALY gained were calculated using the bootstrap method, and probabilities of being cost-effective were presented using a cost-effectiveness acceptability curve. Sensitivity analyses were performed to test the robustness of the results. RESULTS: Mean logarithm of the minimum angle of resolution BCVA in the operated eye increased from 1.37 ± 0.5 (Snellen, 20/469) to 0.98 ± 0.25 (Snellen, 20/191) (p < 0.001); BCVA in the weighted average from both eyes (=75% better eye + 25% worse eye) was changed from 1.13 ± 0.22 (Snellen, 20/270) to 0.96 ± 0.17 (Snellen, 20/182) (p < 0.001). Utility values from both patients and doctors increased significantly after surgery (p < 0.001 and p = 0.007). Patients gained 1.17 QALYs by cataract surgery in their lifetime. The cost per QALY was 8835 Chinese yuan (CNY) (1400 U.S. dollars [USD]). It is cost-effective at the threshold of 115,062 CNY (18,235 USD) per QALY in China recommended by the World Health Organization. The cost per QALY varied from 7045 CNY (1116 USD) to 94,178 CNY (14,925 USD) in sensitivity analyses. CONCLUSIONS: Visual acuity and quality of life assessed by utility value improved significantly after surgery. Cataract surgery was a cost-effective intervention for patients with coexistent AMD.

Physical activity restriction in age-related eye disease: a cross-sectional study exploring fear of falling as a potential mediator.

BACKGROUND: Fear of falling (FoF) is predictive of decreased physical activity. This study sought to determine if FoF mediates the relationship between decreased vision and physical activity restriction in individuals with glaucoma and age-related macular degeneration (AMD). METHODS: Accelerometers were used to measure physical activity over 1 week in 59 control, 83 glaucoma, and 58 AMD subjects. Subjects completed the University of Illinois at Chicago Fear of Falling Questionnaire, and the extent of FoF was estimated using Rasch analysis. In negative binomial models adjusting for demographic, health, and social factors, FoF was investigated as a potential mediator between the severity of visual field (VF) loss (in glaucoma patients) or the severity of contrast sensitivity (CS) loss (in AMD patients) and decreased engagement in physical activity, defined as minutes spent in moderate-to-vigorous physical activity (MVPA) per day. RESULTS: In multivariate negative binomial regression models, 5-decibels worse VF mean deviation was associated with 26 % less engagement in MVPA [rate ratio (RR) = 0.74, p < 0.01] amongst glaucoma subjects. When FoF was added to the model, the RR increased from 0.74 to 0.78, and VF loss severity remained associated with less MVPA at a statistically significant level (p < 0.01). Likewise, 0.1 log units worse CS was associated with 11 % less daily MVPA (RR = 0.89, p < 0.01) amongst AMD subjects. When FoF was added to the model, the RR increased from 0.89 to 1.02, and CS loss was no longer associated with MVPA at a statistically significant level (p = 0.53). CONCLUSIONS: FoF may mediate the relationship between vision loss and physical activity restriction amongst patients with AMD. Future work should determine optimal strategies for reducing FoF in individuals with vision loss in order to prevent the deleterious effects of physical activity restriction.

Misidentifying a tennis racket as keys: object identification in people with age-related macular degeneration.

PURPOSE: Previous studies showed that people with age-related macular degeneration (AMD) can categorise a pre-defined target object or scene with high accuracy (above 80%). In these studies participants were asked to detect the target (e.g. an animal) in serial visual presentation. People with AMD must rely on peripheral vision which is more adapted to the low resolution required for detection than for the higher resolution required to identify a specific exemplar. We investigated the ability of people with central vision loss to identify photographs of objects and scenes. METHODS: Photographs of isolated objects, natural scenes and objects in scenes were centrally displayed for 2 s each. Participants were asked to name the stimuli. We measured accuracy and naming times in 20 patients with AMD, 15 age-matched and 12 young controls. RESULTS: Accuracy was lower (by about 30%) and naming times were longer (by about 300 ms) in people with AMD than in age-matched controls in the three categories of images. Correct identification occurred in 62-66% of the stimuli for patients. More than 20% of the misidentifications resulted from a structural and/or semantic similarity between the object and the name (e.g. spectacles for dog plates or dolphin for shark). Accuracy and naming times did not differ significantly between young and older normally sighted participants indicating that the deficits resulted from pathology rather than to normal ageing. CONCLUSIONS: These results show that, in contrast to performance for categorisation of a single pre-defined target, people with central vision loss are impaired at identifying various objects and scenes. The decrease in accuracy and the increase in response times in patients with AMD indicate that peripheral vision might be sufficient for object and scene categorisation but not for precise scene or object identification.

Seeing the unseen: Charles Bonnet syndrome revisited.

Charles Bonnet syndrome (CBS) is a rare condition that encompasses three clinical features: complex visual hallucinations, ocular pathology causing visual deterioration, and preserved cognitive status. Common associated ocular pathologies include age-related macular degeneration, glaucoma, and cataracts. Several theories have been proposed to try to explain the visual hallucinations. However, the pathophysiology remains poorly understood, and treatment is largely based on anecdotal data. The lack of awareness of CBS among medical professionals often leads to inappropriate diagnosis and medication. In a country like India, where awareness of mental health is not widespread, cultural myths and stigma prevent patients from seeking professional help. Here we describe two cases of CBS and revisit different ocular morbidities that have been reported to occur in conjunction with CBS. Psychiatrists and ophthalmologists alike must be sensitive to this clinical condition to ensure prompt diagnosis and treatment.