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Purpose: The Treatment exit Options For non-infectious Uveitis (TOFU) registry documents disease courses for non-anterior non-infectious uveitis entities with and without treatment to generate more evidence for clinical management recommendations including treatment exit strategies. In this article, we present the participants' baseline characteristics after the first 3 years., Methods: TOFU is an observational, prospective registry and recruits patients ≥18 years of age with non-anterior non-infectious uveitis with or without a history of previous disease-modifying antirheumatic drugs (DMARDs) treatment. The data are collected in the electronic data capture software REDCap and include ophthalmological and general medical history as well as clinical findings., Results: Between 24.10.2019 and 27.12.2022, 628 patients were enrolled at 25 clinical sites in Germany and Austria. Patients with intermediate uveitis were most frequently included (n=252; 40.1%) followed by posterior uveitis (181; 28.8%), panuveitis (n=154; 24.5%) and retinal vasculitis (n=41, 6.5%). At baseline, 39.6% were treated with systemic corticosteroids, 22.3% with conventional synthetic (cs) DMARDs, 20.5% with biological (b) DMARDs and 3.6% with other systemic treatments. Average best corrected visual acuity (BCVA) was 0.69 decimal. Patients with panuveitis had the worst BCVA with 0.63 decimal. Overall, only 8 patients (1.3%) suffered from severe visual impairment., Conclusions: Less than half of participants required DMARD treatment at baseline, with csDMARDs used more frequently than bDMARDs. The presence of severe visual impairment was low, mostly affecting patients with panuveitis. These findings are in line with comparable monocentric cross-sectional studies of tertiary uveitis centres in Germany and will allow us to generate generalisable evidence in TOFU., Competing Interests: Competing interests: CH is a consultant for Alimera Sciences (Aldershot, Hampshire, UK) and received Honoria from AbbVie and Novartis. MWMW is a consultant for Heine Optotechnik GmbH and glaucare GmbH, has received honoraria from ASKIN & CO GmbH, Bayer AG, Berlin-Chemie AG, Heidelberg Engineering, Novartis Pharma GmbH, Pro Generika e.V., Eyepress Fachmedien GmbH, and Science Consulting in Diabetes GmbH, and research funding from CenterVue SpA, Carl Zeiss Meditec, and Novartis Pharma GmbH. RPF is a consultant for Alimera, Apellis, Biogen, Böhringer-Ingelheim, Bayer, Caterna, Novartis, ODOS, ProGenerika, Roche/Genentech, has received honoraria from Roche and research funding from Biogen. He is member of the advisory board of Stada Pharm, Roche and Opthea. CMED is a member of the advisory board of Alimera and he has received honoraria from AbbVie, Novartis, Santen and Thea. His institution received funding for clinical trials from Tarsier and Roche. UP received study support from Abbvie and honoraria from Abbvie, Alimera and Novartis. None of the following authors have any proprietary interests or conflicts of interest related to this submission: DJF, JD, TH, MB, MS, HR, KTB and TKL., (© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Importance: Neovascular age-related macular degeneration (nAMD), the largest single cause of irreversible severe vision loss in high-income countries, can now be treated with vascular endothelial growth factor (VEGF) inhibitors, but to our knowledge, no data on lifetime outcomes are available., Objective: To determine visual acuity (VA) outcomes of anti-VEGF treatment for nAMD in both eyes for patients' remaining lifetime., Design, Setting, and Participants: Multistate modeling using real-world cohort data of 3192 patients with nAMD (>67 000 visits) treated in routine eye clinics in Australia, New Zealand, and Switzerland. Data were analyzed between 2007 and 2015., Exposures: Intravitreal anti-VEGF treatment at the treating physician's discretion and prospective data collection in standardized registry., Main Outcomes and Measures: Visual acuity in both eyes over the remaining lifetime., Results: For the mean remaining lifetime of 11 years, an estimated 12% (n = 371; 95% CI, 345-400) of the sample retained driving VA and an estimated 15% (n = 463; 95% CI, 434-495) reading VA in at least 1 eye. At that time, an estimated 82% of the sample (n = 2629; 95% CI, 2590-2660) had dropped out. Younger age at baseline and more injections during the first year of treatment were associated with better long-term outcomes., Conclusions and Relevance: Anti-VEGF treatment was associated with preserved useful visual acuity in almost 20% of patients over their average remaining lifetime. More than 80% of patients will cease treatment over that time, having likely experienced a deterioration of vision beforehand. This is a remarkable outcome compared with outcomes without intervention, which lead to legal blindness within 3 years of disease onset in 80% of those affected. These findings underline the public health necessity of providing anti-VEGF treatment to persons in need.

Purpose: To investigate the relationship between patient-reported outcome (PRO) questionnaire responses and time to late age-related macular degeneration (AMD; neovascular AMD [nAMD] or multimodal imaging [MMI]-defined atrophy) among individuals with bilateral large drusen, and the prognostic value of baseline PROs for 36-month AMD status., Design: Exploratory analyses from a multicenter randomized controlled trial of an AMD intervention (Australian New Zealand Clinical Trials Registry identifier, ACTRN12612000704897)., Participants: Sham treatment group of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n = 141; age, 50-88 years; 77% female)., Methods: The 28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10) were administered at the baseline visit. The PRO scores were derived using rating scale models. Multivariate Cox regression adjusting for demographics and clinical measures of vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity) from the poorer-performing eye was used to investigate the association between PRO scores and time to late AMD in either eye. Multivariate competing-risk regression was used to estimate cause-specific subhazard ratios for nAMD and atrophy in either eye. Cross-validated logistic lasso models were used to estimate the predicted probability of AMD at 36 months. The area under the receiver operating characteristic curve was assessed to compare prognostic accuracy between models with and without PROs., Main Outcome Measure: Time until nAMD or atrophy in either eye., Results: The PRO scores were skewed toward higher functional vision. Higher IVI-28 scores were associated with a lower risk of progression to MMI-defined atrophy (20 events: adjusted hazard ratio, 0.65/logit increase; P = 0.002) but not nAMD (10 events; P = 0.562). Insufficient evidence was found of an association between NVQ-10 score and rate of progression to late AMD (P ≥0.149). Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010)., Conclusions: On average, PROs were associated with an increased risk of progression from intermediate AMD to MMI-defined atrophy. Continuing development of instruments to record PROs in the early stages of AMD have the potential to produce inexpensive and efficient tools to assist in the assessment of disease severity and risk of AMD progression., (Copyright © 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess which visual function measures are most strongly associated with overall retinal drusen volume in age-related macular degeneration (AMD)., Methods: A total of 100 eyes (16 eyes with early AMD, 62 eyes with intermediate AMD, and 22 eyes from healthy controls) were recruited in this cross-sectional study. All subjects underwent several functional assessments: best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), visual acuity (VA) measured with the Moorfields Acuity Chart (MAC-VA), contrast sensitivity with the Pelli-Robson test, reading speed using the International Reading Speed texts, and mesopic and dark-adapted microperimetry. Drusen volume was automatically determined based on optical coherence tomography using an approach based on convolutional neural networks. The relationship between drusen volume and visual function was assessed with linear regressions controlling for confounders., Results: Mean drusen volume and MAC-VA differed significantly among all AMD stages and controls (P < 0.001). In univariate linear regression, LLVA, MAC-VA, contrast sensitivity, and mesopic and dark-adapted microperimetry were significantly negatively associated with the overall drusen volume (all P < 0.006). After controlling for AMD stage, age, and the presence of subretinal drusenoid deposits, MAC-VA and mesopic and dark-adapted microperimetry were still significantly associated with drusen volume (P = 0.008, P = 0.023, and P = 0.022, respectively)., Conclusions: Our results suggest that MAC-VA, as well as mesopic and dark-adapted microperimetry, might indicate structural changes related to drusen volume in early stages of AMD.

Purpose: To evaluate the secondary and exploratory outcomes of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study, a 36-month trial of a subthreshold nanosecond laser (SNL) treatment for slowing the progression to late age-related macular degeneration (AMD) in its early stages., Design: Multicenter, randomized, sham-controlled trial., Participants: Two-hundred ninety-two patients with bilateral large drusen., Methods: Participants were randomly assigned to receive SNL or sham treatment to the study eye at 6-month intervals., Main Outcome Measures: The secondary outcome measure of the LEAD study was the time to development of late AMD, defined by multimodal imaging in the non-study eye. The exploratory outcome measures were the rate of change in best-corrected visual acuity (BCVA), low-luminance visual acuity, microperimetric mean sensitivity, drusen volume in the study and non-study eyes, and participant-reported outcomes based on the Night Vision Questionnaire and Impact of Vision Impairment questionnaire., Results: Progression to late AMD in the non-study eye was not significantly delayed with SNL treatment (hazard ratio, 0.83; 95% confidence interval, 0.40-1.71; P = 0.611). There was no evidence of effect modification based on the coexistence of reticular pseudodrusen; interaction P = 0.065). There was no significant difference between study groups in the rate of change of low-luminance visual acuity, microperimetric mean sensitivity, and drusen volume in the study or non-study eyes, and Night Vision Questionnaire and Impact of Vision Impairment questionnaire scores (all P ≥ 0.167). The rate of BCVA decline was slightly higher for participants in the SNL group compared with the sham treatment group in the study eye (-0.54 and 0.23 letters/year, respectively; P < 0.001) but not the non-study eye (-0.48 and -0.56 letters/year, respectively; P = 0.628)., Conclusions: Subthreshold nanosecond laser treatment of one eye did not have an effect on delaying progression to late AMD in the fellow eye and did not, in general, have an impact on the exploratory structural, functional, and participant-reported outcomes., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Background: Real-world data (RWD) has been a valuable addition to the scientific literature regarding treatment pathways, clinical outcomes and characteristics of patients with retinal diseases in recent years. Registries, observational studies and patient databases are often used for real-world research. However, there is limited information for each data source on the design, consistency, data captured, limitations and usability for assessing research questions. Using a systematic approach, we identified RWD sources for patients with retinal diseases and assessed them for completeness of data relating to different outcomes., Methods: A systematic literature review was carried out to identify RWD sources for patients with retinal disease. Potentially relevant articles published between 2006 and 2016 were screened following electronic searches in Embase and MEDLINE. Congress and supplementary searches were undertaken to identify RWD sources that may not be referenced in full publications. For each data source, availability and quantity of data on baseline status, clinical outcomes, treatment and management, safety, and patient-reported and economic burden were assessed using a bespoke completeness assessment tool based on International Consortium for Health Outcomes Measurement guidelines for macular degeneration. Completeness of data for each area of interest in each data source was assessed and rated using a 'good-moderate-poor' rating system based on availability and quantity of available data. Each data source was then given an overall score based on its score for each of the 7 areas of interest., Results: A total of 128 RWD sources from 32 countries were identified. Of the identified sources, 64 sources from 16 countries of interest were analyzed. Most of these sources provided information on baseline status and clinical outcomes and treatment, but few collected data on economic and patient-reported burden. Of the RWD sources analyzed, 10 scored highly in the overall completeness assessment, collecting data on most or all of the areas of interest; these sources are considered to be robust data sources for performing ophthalmology real-world studies., Conclusions: The study provides a comprehensive list of RWD sources for patients with retinal disease, many of which will be useful for conducting real-world studies in the field of ophthalmology.

Randomized controlled trials are the gold standard in medical research, providing evidence of the efficacy of a treatment in well-defined patient populations. By contrast, real-world studies explore the effectiveness of treatments in routine clinical practice, often with diverse patient populations. Although both randomized controlled trials and real-world studies contribute to the understanding of the benefits and risks of therapies, they generate different types of data and serve complementary purposes. Real-world studies evaluating the management of neovascular age-related macular degeneration have shown that visual outcomes achieved with anti-vascular endothelial growth factor in clinical practice often differ from those derived from clinical trials, highlighting the importance of assessing such outcomes in real-world studies. Benefits include finding variations in treatment provision, leading to: service improvements; the understanding of the need for continued and higher than previously provided treatment frequency; and new treatment regimens such as treat-and-extend. There is potential for the scope of real-world studies to be expanded to include other patient outcomes, such as quality of life, thus providing decision-makers with additional information to complement the data collected in randomized controlled trials. Physicians, patients, and regulators stand to gain much from further development and the conduct of real-world studies. We provide an overview of the importance of real-world evidence in the management of neovascular age-related macular degeneration with anti-vascular endothelial growth factor therapy, describe sources of real-world evidence, and assess the relative strengths and limitations of randomized controlled trials and real-world studies., (Copyright © 2019. Published by Elsevier Inc.)

Purpose: Most definitions of visual impairment focus on the status of the better-seeing eye only, but this approach might underestimate the influence of the worse-seeing eye on the vision-related quality of life (VRQoL)., Methods: We assessed distance-corrected visual acuity in both eyes and VRQoL using the "National Eye Institute 25-Item Visual Function Questionnaire" (NEI VFQ-25) in the German population-based Gutenberg Health Study. We calculated the Rasch-based visual functioning scale (VFS) and socioemotional scale (SES). We categorized the visual acuity of the better-seeing eye (BE) and worse-seeing eye (WE) as follows: (1) no visual impairment (VI) (< 0.32 logMAR)), (2) mild VI (0.32-0.5 logMAR), and (3) moderate to severe VI (> 0.5 logMAR). Next, the subjects were categorized as follows: both eyes with no VI (no/no), the better-seeing eye with no VI and the worse-seeing eye with mild VI (no/mild), no VI/severe VI (no/severe), both eyes with mild VI (mild/mild), light VI/severe VI (mild/severe), and both eyes with severe VI (severe/severe). We calculated the median scores for VFS and SES. We used linear regression to estimate the combined influence of BE/WE on VFS and SES., Results: We included 11,941 participants (49.9% female, age range: 35-74 years) with information on VRQoL and visual acuity. The median VFS/SES scores were 90/100 (no/no VI group), 84/97 (no/mild group), 81/94 (no/severe group), 70/90 (mild/mild group), 67/74 (mild/severe group), and 63/76 (severe/severe group). These differences were supported by the regression analysis results., Conclusion: Relying on the function of the better-seeing eye considerably underestimates the impact of visual impairment on VRQoL.

Purpose: To determine the prevalence of and identify factors associated with visual impairment and blindness in institutionalized elderly in Germany., Methods: In this prospective multicenter cross-sectional study, ophthalmic health care need and provision were investigated in institutionalized elderly in 32 nursing homes in Germany. All participants underwent a standardized examination including medical and ocular history, refraction, visual acuity testing, tonometry, biomicroscopy, and dilated funduscopy. A standardized questionnaire was used to identify factors associated with eye healthcare utilization, visual impairment and/or blindness., Results: Visual acuity of 566 (94.3%; 413 women and 153 men) of a total of 600 institutionalized elderly was determined. Mean age of the included patients was 82.9 years (± 9.8). Of all participants, 30 (5.3%; 95% CI 3.4-7.2%) were blind and 106 (18.7%; 95% CI 15.5-21.9%) were moderately or severely visually impaired according to the World Health Organization definition. The 136 blind and moderately or severely visually impaired participants were older (OR, Odds Ratio = 1.1, 95% CI 1.0-1.1; p < 0.001), and more likely to have reduced mobility (OR = 12.6, 95% CI 2.8-57.6; p = 0.001)., Conclusion: A high proportion of blindness and visual impairment was found amongst nursing home residents. Age and reduced mobility were factors associated with an increased likelihood of blindness and visual impairment. Any surveys of blindness and visual impairment excluding nursing homes may considerably underestimate the prevalence of visual impairment and blindness.

Purpose: Currently, no outcome measures are clinically validated and accepted as clinical endpoints by regulatory agencies for drug development in intermediate age-related macular degeneration (iAMD). The MACUSTAR Consortium, a public-private research group funded by the European Innovative Medicines Initiative intends to close this gap., Procedures: Development of study protocol and statistical analysis plan including predictive modelling of multimodal endpoints based on a review of the literature and expert consensus., Results: This observational study consists of a cross-sectional and a longitudinal part. Functional outcome measures assessed under low contrast and low luminance have the potential to detect progression of visual deficit within iAMD and to late AMD. Structural outcome measures will be multimodal and investigate topographical relationships with function. Current patient-reported outcome measures (PROMs) are not acceptable to regulators and may not capture the functional deficit specific to iAMD with needed precision, justifying development of novel PROMs for iAMD. The total sample size will be n = 750, consisting mainly of subjects with iAMD (n = 600)., Conclusions: As clinical endpoints currently accepted by regulators cannot detect functional loss or patient-relevant impact in iAMD, we will clinically validate novel candidate endpoints for iAMD., (© 2018 S. Karger AG, Basel.)

Background: To estimate the burden of diseases, it is important to consider patient-reported outcomes including Quality of Life (QoL). The aim of this study is to provide population-based reference data for the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25), stratified by sex and age., Methods: The Gutenberg Health Study (GHS) is a population-based, prospective, observational cohort study in Germany, including 15,010 participants aged between 35 and 74. The baseline examination was conducted between 2007 and 2012. To overcome known shortcomings of the NEI VFQ-25, we calculated the previously proposed visual functioning scale and the socio-emotional scale based on Rasch-transformed person-level data. We present mean values, standard deviations and percentiles for age decades stratified by sex. We used a linear regression model to assess the influence of age, sex, socioeconomic status, distance-corrected visual acuity (better-seeing eye) and the absolute difference in distance-corrected visual acuity of both eyes on vision-related QoL., Results: NEI VFQ-25 data are available from 12,231 participants (82%). Both the long-form visual functioning scale (LFVFS) and the long-form socio-emotional scale (LFSES) showed a clear age dependency, with an average LFVFS score of 92.8 for men and 90.5 for women in the youngest age group and 85.7 and 83.4 in the oldest age group, and a LFSES score of 98.3 for men and 98.1 in women in the youngest and 94.7 and 94.5 in the oldest decade. The largest difference was observed between the youngest age group (35-44 years) and the 45-54 years group. Men tended to have slightly higher scores than women. In the multivariable linear regression analysis, age (per 5 years -0.42), female sex (-1.57), worse distance-corrected visual acuity of the better eye (per 0.1 increase in logMAR -2.92) and the difference between both eyes (per 0.1 increase in logMAR -0.87) were associated with a reduced LFVFS score (all p < 0.001). For the LFSES score, we showed that the influence of sex was minor, and that age (per 5 years -0.22), visual acuity of the better eye (-1.65), and the difference between both eyes (-0.56) were associated with a lower score (all p < 0.001)., Conclusions: We report age- and sex-specific reference data from a large population-based study of mainly Caucasian ethnicity of two unidimensional scores based on Rasch-transformed NEI VFQ-25 data. Vision-related QoL is lower in older and in female individuals. Our results support the association of vision-related QoL not only with the distance-corrected visual acuity of the better eye but also with the difference in visual acuity between each eye. Our findings could be used as a reference for comparison in future studies addressing the influence of eye diseases on vision-related QoL.

Purpose: This study aimed to determine the feasibility of an assessment of vision-related orientation and mobility (O&M) tasks in persons with severe vision loss. These tasks may be used for future low vision rehabilitation clinical assessments or as outcome measures in vision restoration trials., Methods: Forty legally blind persons (mean visual acuity logMAR 2.3, or hand movements) with advanced retinitis pigmentosa participated in the Orientation & Mobility-Very Low Vision (O&M-VLV) subtests from the Low Vision Assessment of Daily Activities (LoVADA) protocol. Four categories of tasks were evaluated: route travel in three indoor hospital environments, a room orientation task (the "cafe"), a visual exploration task (the "gallery"), and a modified version of the Timed Up and Go (TUG) test, which assesses re-orientation and route travel. Spatial cognition was assessed using the Stuart Tactile Maps test. Visual acuity and visual fields were measured., Results: A generalized linear regression model showed that a number of measures in the O&M-VLV tasks were related to residual visual function. The percentage of preferred walking speed without an aid on three travel routes was associated with visual field (p < 0.01 for all routes) whereas the number of contacts with obstacles during route travel was associated with acuity (p = 0.001). TUG-LV task time was associated with acuity (p = 0.003), as was the cafe time and distance traveled (p = 0.006 and p < 0.001, respectively). The gallery score was the only measure that was significantly associated with both residual acuity and fields (p < 0.001 and p = 0.001, respectively)., Conclusions: The O&M-VLV was designed to capture key elements of O&M performance in persons with severe vision loss, which is a population not often studied previously. Performance on these tasks was associated with both binocular visual acuity and visual field. This new protocol includes assessments of orientation, which may be of benefit in vision restoration clinical trials.

Purpose: To assess the impact of VA loss on patient reported utilities taking both eyes into account compared to taking only the better or the worse eye into account., Methods: In this cross-sectional study 1085 patients and 254 controls rated preferences with the generic health-related (EQ-5D; n = 868) and vision-specific (Vision and Quality of Life Index (VisQoL); n = 837) multi-attribute utility instruments (MAUIs). Utilities were calculated for three levels of VA in the better and worse eyes, as well as for 6 different vision states based on combinations of the better and worse eye VA., Results: Using the VisQoL, utility scores decreased significantly with deteriorating vision in both the better and worse eyes when analysed separately. When stratified by the 6 vision states, VisQoL utilities decreased as VA declined in the worse eye despite stable VA in the better eye. Differences in VisQoL scores were statistically significant for cases where the better eye had no vision impairment and the worse seeing fellow eye had mild, moderate or severe vision impairment. In contrast, the EQ-5D failed to capture changes in better or worse eye VA, or any of the six vision states., Conclusions: Calculating utilities based only on better eye VA or using a generic MAUI is likely to underestimate the impact of vision impairment, particularly when the better eye has no or little VA loss and the worse eye is moderately to severely visually impaired. These findings have considerable implications for the assessment of overall visual impairment as well as economic evaluations within eye health.

Purpose: To evaluate effectiveness, tolerability and safety of repeated intravitreal injections of 0.5 mg ranibizumab for the treatment of neovascular age-related macular degeneration in routine medical practice in Germany., Methods: A noninterventional study with 3470 patients treated in 274 medical centres according to German guidelines, with monthly intravitreal injections of 0.5 mg ranibizumab during upload (3 months) followed by a maintenance phase (9 months) with reinjections if medically indicated., Results: Mean injection rate was 4.34 (SE = 0.05; median = 3.0). Best-corrected visual acuity (BCVA) remained stable (mean change 0.02 LogMAR, SE = 0.01, p = 0.0169) and central retinal thickness (CRT) decreased (by -78.9 μm, SE = 2.95 μm, p < 0.0001). The NEI-VFQ 25 summary score showed a positive stabilization with a mean change of 0.73 (SE = 0.37, p = 0.0501) compared with baseline. Adverse events were documented for 6.5% of the patients with 3.9% of these events being classified as serious., Conclusions: The number of administered intravitreal injections of ranibizumab over the first year of treatment was very low but still achieved a stabilization of BCVA, a reduction in CRT and maintained vision-related quality of life. The management of patients with neovascular AMD in Germany needs to be improved to achieve better treatment results., (© 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.)

Purpose: Multi-attribute utility instruments (MAUIs), which contain a descriptive system, including several health dimensions with associated levels of increasing severity, are used commonly to measure utilities. However, the validity of the descriptive systems rarely is examined using modern psychometric theory. Therefore, we evaluated the psychometric properties of the German version of the Vision and Quality of Life Index (VisQol), a six-item vision-related MAUI., Methods: The German VisQol was self-administered to 340 patients and 280 controls. All subjects underwent a full ophthalmologic examination, including best-corrected visual acuity (VA) testing. The psychometric properties of the VisQoL were assessed using Rasch analysis., Results: The VisQoL's descriptive system did not function in controls. In patients, after collapsing response categories to resolve disordered thresholds and omitting misfitting persons, the measurement properties (i.e., precision, unidimensionality, and targeting) of the German VisQoL were satisfactory. Most person misfit related to unexpected responses to item 4 ("organizing assistance"). Rasch-generated person estimates were not different between age categories, sex, or underlying ocular condition, but decreased significantly with presence of visual impairment in the better eye (LogMAR ≥ 0.5, 1.20 ± 4.62 compared to 3.46 ± 3.52, P < 0.001)., Conclusions: The German VisQoL's descriptive system displayed adequate fit to the Rasch model after removal of a large proportion of patients with poor fit statistics. However, the wording of item four should be revised to reduce respondent confusion and measurement "noise." The scale's descriptive system does not function in a sample of visually unimpaired persons, most likely due to a lack of variance in the measured trait.

Purpose: To assess the effect of ranibizumab treatment for neovascular age-related macular degeneration (nvAMD) on patients' preferences and vision-related quality of life (VRQoL) in a routine clinical setting., Methods: 55 treatment naïve patients were examined before and after the initial upload of three monthly injections of 0.5 mg ranibizumab. VRQoL was assessed using a Rasch-adjusted NEI-VFQ-25. Time trade-off (TTO), standard gamble, a visual analogue scale and the European Quality of Life Questionnaire (EQ-5D) were used to calculate utilities, and multiple logistic regression models were conducted to determine independent factors associated with utilities., Results: Mean ± SD age was 75 ± 7 years, and 40 patients (73%) were female. Mean ± SD best-corrected visual acuity of the treated eye increased from 20/80 at baseline (logMAR 0.60 ± 0.35) to 20/63 (logMAR 0.52 ± 0.36; p=0.020) at follow-up after three injections. Utility score increases ranged from 2 utils (standard gamble anchored for death) up to 6.6 utils (EQ-5D German TTO, p=0.023) and visual functioning improved (Rasch adjusted composite NEI-VFQ score 50 ± 21 to 54 ± 21, p=0.042). Whether the worse or better eye was treated was not significantly associated with improvements in utility or VRQoL, whereas VA improvement in the treated eye was associated with an increase in utility (TTO, p=0.020)., Conclusions: TTO performed best in this sample of elderly nvAMD patients undergoing anti-VEGF therapy. Better or worse eye treatment was not associated with a change in reported utilities or visual functioning in patients with newly diagnosed nvAMD. Directly elicited, vision-specific utilities gained with TTO seem to be sensitive to a change in vision status.

Purpose: To validate the German-translated Low Luminance Questionnaire (LLQ), a vision-related quality of life scale assessing mainly mesopic and scotopic functioning, and to determine the relationship between the severity of vision impairment, ocular conditions, and low luminance-related visual functioning., Methods: In all, 274 participants, 184 patients with visual acuity <6/12 or a long-standing symptomatic eye condition and 90 controls, were recruited from an outpatient clinic at a German eye hospital. Participants underwent a clinical examination and completed the German LLQ and VF-14 scales. The validity and psychometric properties of the scales were assessed using Rasch analysis exploring key indices, such as instrument unidimensionality, discriminant ability, and targeting of item difficulty to patient ability. Multivariate analyses of low luminance functioning were adjusted for conventional visual functioning (VF-14 scores)., Results: The 30-item German LLQ initially displayed poor fit to the Rasch model. Following Rasch-guided iterative adjustments to the scale, a 23-item LLQ emerged as a valid and unidimensional scale. Visual functioning under low luminance consistently declined with worsening vision loss. Compared with patients with no vision impairment, those with mild or moderate/severe vision impairment recorded significantly poorer low luminance functioning scores (mean change, -6.33 and -16.62; P = 0.032 and P < 0.001, respectively). Age-related macular degeneration and cataract were independently associated with low luminance visual functioning, as was worse self-reported health., Conclusions: Low luminance functioning is considerably compromised in visually impaired patients even at the mild spectrum of visual acuity loss. Additionally, the impact of age-related macular degeneration and cataract on patients' low luminance functioning is substantially independent of vision impairment.

Background: To validate the German-translated VF-14, a vision-specific scale, and determine the relationship between the severity of vision impairment, ocular conditions, and visual functioning., Methods: This was a clinic-based, cross-sectional study with 184 patients with low vision and 90 normal-sighted controls recruited from a German eye hospital. Participants underwent a clinical examination and completed the German VF-14 scale. The validity of the VF-14 scale was assessed using Rasch analysis. The main outcome measure was the visual functioning overall score., Results: The participants' mean ± SD [standard deviation] age was 59.4 ± 21.8 years ,and there were more female (58.4%) than male participants. The main cause of vision loss was age-related macular degeneration [AMD] (n = 54, 19.7%). Rasch analysis substantiated the German VF-14 to be a valid scale to assess visual functioning in the sample. Visual functioning consistently declined with worsening vision. In adjusted-multivariate analysis models, compared to control participants, those with mild, or moderate/severe vision impairment recorded significantly poorer visual functioning scores (p < 0.05). The independent association was clinically significant for those with moderate/severe vision impairment. The main ocular conditions were also found to be independently associated with worse visual functioning, with clinical significance found for AMD, diabetic retinopathy, and other retinal diseases., Conclusions: Using a psychometrically valid German-translated VF-14, even mild vision impairment was independently associated with poor visual functioning. These findings reinforce the importance of early preventative and rehabilitative efforts to prevent longitudinal deterioration in vision loss.