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Background: To assess the clinical and patient-centred effectiveness of a novel residential ocular care (ROC) model in Australian individuals residing in residential care., Methods: In this prospective, multicentred, randomised controlled trial conducted in 38 Australian aged-care facilities (2015-2017), 178 visually impaired individuals living in residential care facilities (mean age ±SD: 83.9±8.6 years; 65.7% women) were cluster randomised to ROC (n=95) or usual care (n=83) pathways. The ROC arm comprised a tailored and comprehensive within-site eye examination and care rehabilitation pathway, while usual care participants were given a referral to an external eyecare provider. Outcomes included presenting distance and near visual acuity (PNVA); Rasch-transformed Reading, Emotional and Mobility scores from the Impact of Vision Impairment questionnaire; quality of vision (QoV comprising Rasch-transformed Frequency, Severity and Bother domains) scores; Euroqol-5-Dimensions (raw scores); Cornell Scale for Depression (raw scores) and 6-month falls frequency, assessed at baseline and 6 months post intervention. Within-group and between-group comparisons were conducted using linear mixed models, adjusted for baseline differences in characteristics between the two arms., Results: At 6 months, intention-to-treat analyses showed significant between-group improvements in ROC residents compared with usual care for PNVA, Emotional and QoV scores (all p<0.05) These significant findings were retained in per-protocol analyses. No other between-group changes were observed., Conclusion: Our ROC model was effective in improving near vision, emotional well-being and perceived burden of vision-related symptoms in residential care dwellers in Australia with vision impairment. Future studies to evaluate the cost effectiveness and implementation of ROC in Australia are warranted., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Previous work has reported a link between diabetic retinopathy/diabetic macular edema (DR/DME) and psychosocial functioning, although the extent and direction of the association remains uncertain., Objective: To determine the relationship between DR/DME and psychosocial functioning, the latter an umbrella term used to capture the emotional and social aspects of functioning which may include, for example, depression; depressive disorder; anxiety; vision-specific distress; diabetes-specific distress and emotional and social well-being., Evidence Review: PubMed, Embase, Medline and the Cochrane Central register were systematically searched for relevant interventional and observational quantitative studies using standardised criteria. Studies with DR/DME and psychosocial functioning as exposures or outcomes were accepted. Study quality was evaluated using the modified Newcastle-Ottawa scale for observational studies, and the modified Down's and Black checklist for interventional studies., Findings: Of 1827 titles initially identified, 42 were included in the systematic review. They comprised of four interventions (one RCT, three non-RCTs) and 38 observational studies (33 cross sectional, five prospective). In studies with DR/DME as the exposure (n = 28), its severity and related vision impairment were consistently associated with poor psychosocial outcomes, mostly higher incidence of depression and depressive symptoms. Baseline depression and depressive symptoms were also associated with greater DR incidence and progression of DR. Medical intervention strategies showed significant improvement in psychosocial outcomes in patients with DR, such as significant improvements in mental health domain scores of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ 25)., Conclusion and Relevance: Severity of DR, DME and associated vision loss are significantly associated with poor psychosocial outcomes. Aspects of depression and its symptoms show a bi-directional association, with increased incidence and progression of DR significant in those with baseline depression or depressive symptoms. Based on these findings, we propose two areas that may benefit from targeted interventions: (1) Prevention of development of poor psychological outcomes by preventing and delaying progression of DR/DME; and (2) Improved detection and management of poor psychological functioning by improving screening tools and multidisciplinary care for patients. Subsequent longitudinal studies can further help establish the underlying relationship between the two measures.

Background: Older adults in residential aged care facilities have unnecessarily high levels of vision impairment (VI) which are largely treatable or correctable. However, no current comprehensive eye health service model exists in this setting in Australia. We aimed to determine the clinical, person-centered, and economic effectiveness of a novel eye care model, the Residential Ocular Care (ROC)., Methods/design: This protocol describes a multicentered, prospective, randomized controlled trial. A total of 395 participants with distance vision < 6/12 (0.30 LogMAR) and/or near vision N8 (1.00 M) or worse will be recruited from 38 urban and rural aged care facilities across Victoria, Australia. Aged care facilities will be randomized (1:1) to one of two parallel groups. Participants in the ROC group will receive a comprehensive and tailored eye care pathway that includes, as necessary, refraction and spectacle provision, cataract surgery, low vision rehabilitation, and/or a referral to an ophthalmologist for funded treatment. Usual care participants will be referred for an evaluation to the eye care service associated with the facility or an eye care provider of their choice. The primary outcome will be presenting near and distance vision assessed at the two- and six-month follow-up visits, post baseline. Secondary outcomes will include vision-specific quality of life, mobility, falls, depression, and eye care utilization at two and six months. An incremental cost-effectiveness analysis will also be undertaken., Discussion: The ROC study is the first multicentered, prospective, customized, and cluster randomized controlled trial in Australia to determine the effectiveness of a comprehensive and tailored eye care model for people residing in aged care facilities. Results from this trial will assist health and social care planners in implementing similar innovative models of care for this growing segment of the population in Australia and elsewhere., Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12615000587505 . Registered on 4 June 2015 - retrospectively registered.

Aims: We explored the direct and indirect impact of restrictions in daily living activities on the relationship between perceived visual symptoms associated with diabetic retinopathy (DR) and psychological functioning., Methods: In this prospective, cross-sectional study, 514 tertiary patients with DR (mean age±SD, 60.4±12.6 years; 64% male) answered questions related to nine domains of DR-specific quality of life. These were classified into the following predictor, mediating and outcome variables: visual symptoms (predictor variable); activity limitation, driving, lighting, social restriction, inconvenience, mobility (mediating variables); and emotional distress and concerns (outcome variables). Direct and indirect relationships between study variables were assessed using path analysis, using interval-level person measures derived from Rasch analyses of the study questionnaires., Results: We found no direct effect of DR-related visual symptoms on emotional distress or concerns. Rather, the association between visual symptoms and emotional distress was mediated (all p<0.05) by mobility (indirect effect=0.07), inconvenience (indirect effect=0.28), activity limitation (indirect effect=0.13) and social restriction (indirect effect=0.11). Similarly, the relationship between DR-related visual symptoms and concerns was mediated by inconvenience (indirect effect=0.36) and social restriction (indirect effect=0.11). Lighting and driving did not have a mediating role., Conclusions: The link between vision and psychological functioning outcomes such as emotional distress and concern is complex in patients with DR and mediated by limitations in daily living activities and social factors. Interventions to enhance daily functioning and social interaction may be effective in reducing emotional distress associated with DR-related vision impairment., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Purpose: To develop a psychometrically sound and valid Brief Impact of Vision Impairment (IVI) questionnaire., Methods: Cross-sectional data from four prospective studies (2001-2008) were pooled and randomly divided into development/validation sets (n = 416) each. Items with suboptimal psychometric properties were iteratively removed in the development set to form the Brief IVI. Psychometric properties of the Brief IVI were independently tested in the validation sample. Correlation between person measures from the original and Brief IVI was assessed [Pearson r and intraclass correlation coefficient (ICC)]. Criterion validity was determined by testing the Brief IVI's ability to discriminate levels of vision impairment (analysis of variance, ANOVA). Responsiveness was tested by comparing the ICC of the original and Brief IVI data obtained pre-/post-intervention., Results: The 15-item Brief IVI, and its 9-item Visual Functioning and 6-item Emotional Well-being subscales had ordered thresholds, good precision and targeting, unidimensionality, and minimal item misfit (replicated in the validation sample). Brief and original IVI person measures were highly correlated (r = 0.97 and ICC = 0.98, p < 0.001), indicating the Brief IVI provides statistically similar measurement of vision-related quality of life (VRQoL). Brief IVI mean logit scores declined as vision impairment worsened (p = 0.001) demonstrating criterion validity. ICC of the original versus Brief IVI pre-/post-intervention was excellent (0.98), establishing that the Brief IVI was as responsive to changes in VRQoL as the original., Conclusions: The Brief 15-item IVI can obtain valid and responsive measurement of VRQoL with half the items in the original and has potential to reduce respondent burden in QoL studies.

Purpose: We investigated whether the Chinese impact of vision impairment (IVI) questionnaire is valid to generate reliable person estimates in a population-based sample., Methods: VRQoL was measured using the 32-item Chinese version of the IVI questionnaire in the Singapore Chinese Eye Study (2009-2011), a population-based study of the prevalence and risk factors for VI and eye diseases in Chinese Singaporeans. Rasch analysis was used to assess the Chinese IVI's response category functioning, precision, unidimensionality, targeting and differential item functioning. The ability of the Chinese IVI to discriminate participants along the spectrum of VI demonstrated criterion validity., Results: Of the 3353 participants, 27.2 % (n = 912) had VI (presenting visual acuity <6/12, better eye). Response categories were collapsed from six to four to resolve disordered thresholds. The Chinese IVI initially demonstrated multidimensionality and was split into three scales: 'Reading and Accessing Information'; 'Mobility and Independence'; and 'Emotional Well-being'. All three scales were unidimensional and demonstrated excellent range-based precision (all reliability coefficients 0.97), following removal of three misfitting items. Mean person measures decreased with worsening VI (e.g. Reading: none (7.50 logits); mild (6.99 logits); moderate (6.44 logits); and severe (3.01 logits) VI; p < 0.001)., Conclusions: A three-dimensional 29-item Chinese IVI is a valid tool to assess the impact of VI on VRQoL in a large population-based sample, comprising over a quarter of participants with VI. The 28-item English IVI is also likely to be valid for use in population-based studies; however, this must be demonstrated empirically in future studies.

Purpose: Assessing the efficacy of treatment modalities for diabetic retinopathy (DR) from the patient's perspective is restricted due to a lack of a comprehensive patient-reported outcome measure. We are developing a DR-specific quality of life (QoL) item bank, and we report here on the qualitative results from the first phase of this project., Methods: Eight focus groups and 18 semi-structured interviews were conducted with 57 patients with DR. The sessions were transcribed verbatim and iteratively analysed using the constant comparative method and NVIVO software., Results: Participants had a median age of 58 years (range 27-83 years). Twenty-seven (47%) participants had proliferative DR in the better eye, and 14 (25%) had clinically significant macular oedema. Nine QoL domains were identified, namely visual symptoms, ocular surface symptoms, vision-related activity limitation, mobility, emotional well-being, health concerns, convenience, social, and economic. Participants described many vision-related activity limitations, particularly under challenging lighting conditions; however, socioemotional issues were equally important. Participants felt frustrated due to their visual restrictions, concerned about further vision loss and had difficulty coping with this uncertainty. Restrictions on driving were pervasive, affecting transport, social life, relationships, responsibilities, work and independence., Conclusions: Patients with DR experience many socioemotional issues in addition to vision-related activity limitations. Data from this study will be used to generate data for a DR-specific QoL item bank.

Aim: To assess the impact of early and late age-related macular degeneration (AMD) on vision-specific functioning in Singapore Malays., Methods: AMD was assessed from fundus photographs. The following endpoints were considered for (a) AMD: no AMD, early AMD, and late AMD; (b) drusen: absence and presence; and (c) retinal pigment epithelium (RPE) abnormality: absence and presence. Vision functioning was assessed using the modified VF-11 scale validated using the Rasch analysis. The overall functioning score was used as the main outcome measure., Results: Retinal photographs and vision functioning data were available only for 3252 participants. After age standardisation, the prevalence of early AMD was 3.5% and late AMD 0.34%. In multivariate models, after adjusting for age, gender, education, level of income, smoking status, ocular condition and hypertension, only late AMD was independently associated with poorer vision functioning when compared with no AMD or early AMD (β (β regression coefficient)=-6.4 (CI -11.7 to -2.1; p=0.01)). Early AMD or its principal components, drusen or RPE abnormality, were not independently associated with vision functioning (p>0.05). In adjusted multinomial logistic regression models, people with late AMD were twice as likely (OR=2.23; 95% CI 1.16 to 7.11) to have low overall functioning than those without AMD., Conclusions: Late AMD has a significant impact on visual functioning, but early AMD, drusen and RPE changes have no impact. These data highlight the importance of preventive public health strategies targeting patients with early AMD signs in order to prevent progression to late AMD when visual function is compromised.

Falls are an alarming health problem and a major cause of injury among the elderly. The healthcare cost associated with falls is considerable. Visual acuity has been found to be an independent risk factor for falls; however, the results are not unanimous. Moreover, other aspects of visual function such as visual field, contrast sensitivity and depth perception have not been adequately investigated in relation to falls. The aim of this study, therefore, was to determine the relationship between visual function, duration, and main causes of visual impairment, and falls in individuals with low vision. This was a cross-sectional study involving participants attending a public tertiary eye care hospital. Participants were mobile, aged 60 years or above, and had low vision (visual acuity >0.3 LogMAR in the better eye). Details about falls in the previous 12 months and other information were collected, and patients completed a questionnaire about activities of daily living. The duration and main causes of visual impairment, visual acuity, contrast sensitivity, depth perception, and visual field were assessed. Descriptive statistical analyses were performed to characterize the participants’ sociodemographic and clinical data. One hundred and twenty seven patients (53%; 67 males) with a mean age of 76.3 ± 8.3 years were recruited. Thirty seven percent of the participants ( n = 47) had mild, 50% ( n = 64) moderate and 13% ( n = 16) severe visual impairment (>0.3–0.5; >0.5–1.0; and >1.0 LogMAR respectively). The frequencies of single and multiple falls were 42.5% and 12.6% respectively. Visual acuity, contrast sensitivity, depth perception, visual field, main cause, and duration of visual impairment were not significantly associated with falls ( p > 0.05). In multiple regression analyses, physical inactivity remained the only variable independently associated with falls in all models except for visual field. Overall, visually impaired people were three times more likely to fall if they were physically inactive. Visual function, duration and main causes of visual impairment are not independently associated with falls in people with low vision. However, a significant relationship between non-participation in physical activity and falls was found. Further work is required to investigate the association between vision-related factors and falls in older people with visual impairment. [ABSTRACT FROM AUTHOR]

Purpose: To assess and re-engineer the Vision Core Measure 1 (VCM1) questionnaire in low vision (LV) and cataract participants using Rasch analysis. Methods: 295 participants drawn from a low vision clinic and 181 from a cataract surgery waiting list completed the 10-item VCM1. Unidimensionality, item fit to the model, response category performance, differential item functioning (DIF) and targeting of items to patients were assessed. Category collapsing and item removal were considered to improve the questionnaire. Results: The initial fit of the VCM1 (combined populations) to the Rasch model showed lack of fit (χ 2 = 83.3, df = 50, p = 0.002). There was evidence of DIF between the two populations which could not be resolved. Consequently, each population was assessed separately. Irrespective of the population, disordering of response category thresholds was evident. However, collapsing categories produced ordered thresholds and resulted in fit to the Rasch model for the LV (Total χ 2 = 41.6, df = 30; p = 0.08) and cataract population (Total χ 2 = 17.9, df = 20, p = 0.59). Overall, the VCM1 behaved as a unidimensional scale for each population and no item showed evidence of DIF. Item targeting to patients was however sub-optimal particularly for the cataract population. Conclusion: The VCM1 questionnaire could be improved by shortening the response scale, although different response categories are required for cataract and LV populations. Calibration of items also differed across populations. While the VCM1 performs well within the Rasch model, in line with its initial purpose, it requires the addition of items to satisfactorily target low vision and cataract populations. [ABSTRACT FROM AUTHOR]

Purpose: To assess if the Impact of Vision Impairment (IVI) is a valid instrument to measure participation in daily activities and rehabilitation in patients with age-related macular degeneration (AMD) and varying levels of visual impairment. Methods: Participants, recruited from a public eye hospital and low vision centers, completed the IVI questionnaire. The IVI and its three subscales were assessed for fit to the Rasch model. Unidimensionality, item fit, response category performance, and targeting of items to patients were assessed. Confirmatory factor analysis (CFA) was used to assess the three-factor model of the IVI in this sample of AMD patients. Results: 219 patients (mean ± SD age = 83.5 ± 7.4 yr) were recruited. Of these, 22%, 55% and 23% had mild (< 6/12-6/18), moderate (< 6/18-6/60) and severe (< 6/60) vision loss, respectively. The IVI total and three subscales displayed discrete thresholds indicating that the respondents understood the response categories. The IVI items fitted the scale and unidimensionality was established. Person separation reliability for the IVI score was substantial (0.94) indicating that the scale can discriminate between several groups of AMD patients. The IVI items were significantly targeted to the AMD patients with the means of the two distributions shown to be very close (0.0 and 0.1, respectively). Substantial targeting was also evident for the subscales. Poorer visual acuity was significantly associated (ANOVA; F (2, 216) = 23.4; p < 0.001) with greater restriction of participation suggesting that the IVI has substantial construct validity. CFA supported the IVI three-factor model which includes items from the "emotional well-being, "reading and accessing information" and "mobility and independence" subscales. Conclusions: Clinicians and researchers can reliably use the IVI to assess the impact on daily life and the effectiveness of clinical trials and rehabilitation interventions in patients with AMD across a range of vision loss. [ABSTRACT FROM AUTHOR]