The purpose of this study was to assess which visual function measures are most strongly associated with vision-related quality of life (VRQoL) in age-related macular degeneration (AMD). A cross-sectional study of subjects with early AMD (n = 10), intermediate AMD (n = 42) and late AMD (n = 38) was conducted. Subjects were interviewed with the Impact of Vision Impairment (IVI) questionnaire. Functional tests performed included best-corrected visual acuity (BCVA), low luminance visual acuity (LLVA), visual acuity measured with the Moorfields Acuity Charts (MAC), contrast sensitivity, reading speed, mesopic and dark-adapted microperimetry. The relationship between VRQoL and visual function was assessed with multiple regressions controlling for confounders. Rasch analysis demonstrated the validity of the IVI to assess VRQoL through three subscales: reading and accessing information, mobility and independence, and emotional well-being. Subjects with late AMD had significant lower IVI scores on all subscales compared with intermediate and early AMD (p < 0.011). In the overall cohort, IVI subscales were associated with BCVA, LLVA, MAC-VA and contrast sensitivity (all p < 0.001). Among the subgroup of early and intermediate AMD subjects, reading and mobility subscales were significantly associated with MAC-VA (p < 0.013). These results suggest that MAC-VA is a useful, patient-relevant measure of visual impairment in AMD.
Background: There is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical endpoints need to be developed. Thus, the MACUSTAR study aims to develop and evaluate functional, structural, and patient-reported candidate endpoints for use in future iAMD trials. Methods: The protocol describes a low-interventional clinical multicenter study employing a novel two-part design. The cross-sectional part (total duration, 1 month) and the longitudinal part (total duration, 36 months) include participants with iAMD and control groups with early/late/no AMD. The cross-sectional part's primary objective is a technical evaluation of functional, structural, and patient-reported candidate outcomes. The longitudinal part's primary objective is to assess the prognostic power of changes in functional, structural, and patient-reported outcomes for progression from iAMD to late AMD. All data will be used to support a biomarker qualification procedure by regulatory authorities. Discussion: The MACUSTAR study characterizes and evaluates much needed novel functional, structural, and patient-reported endpoints for future clinical trials in iAMD and will improve our understanding of the natural history and prognostic markers of this condition.
Data Availability Statement: The data proving the main findings of the study are contained within the manuscript. The Optical Coherence Tomography Angiography images of all participants cannot be made publicly available as public availability of the data might compromise participant privacy. All participants consented to scientific analysis of the data by the researchers involved but not to public data sharing (according to the consent form approved by the Ethics committee, University of Bonn). As subjects might be identifiable by the higher for the Mean algorithm compared to the manual approach with respect to the superficial retinal layer. Conclusions Automated thresholding algorithms yield a higher reproducibility of OCTA parameters and allow for a more sensitive diagnosis of macular pathology. However, different algorithms are not interchangeable nor results readily comparable. Especially the Mean algorithm should be investigated in further detail. Automated thresholding algorithms are preferable but more standardization is needed for clinical use.
Hypertensive crisis causes end-organ damage through small-vessel damage as described histologically. Noninvasive optical coherence tomography angiography (OCTA) makes it possible to image retinal and choroidal capillaries on a microscopic level in vivo. We quantified eye vessel perfusion changes in hypertensive crisis using OCTA. Methods: Patients with hypertensive crisis (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) and age-matched healthy controls were included in the study. OCTA en face 3 × 3-mm images of the superficial and deep retinal layers and the choriocapillaris were acquired. Outcome parameters included vessel density (VD) and vessel skeleton density (VSD) of the superficial and deep retinal layers, as well as flow voids of the choriocapillaris. Results: Twenty-eight eyes of 17 patients and 31 age-matched control eyes of 18 healthy subjects were included. VD and VSD of the deep retinal layer were significantly reduced in hypertensive crisis (P ≤ 0.004). Choriocapillaris signal intensity was more heterogeneous in patients, and flow voids exhibited confluence with a larger average area and a lower absolute count (P ≤ 0.045). These changes were independent of time since onset of hypertensive crisis and of the presence and extent of retinopathy. Deep retinal changes were associated with renal end-organ failure (P = 0.045). Conclusions: Hypertensive crisis is associated with a significant reduction in retinal and choroidal capillary perfusion based on OCTA findings. These alterations are independent of retinopathy and related to end-organ damage. Translational Relevance: OCTA might help distinguish hypertensive urgency from hypertensive emergency earlier than currently possible.
The G-BIDQ-S showed good internal consistency, reliability, and convergent, divergent, concurrent, and discriminant validity. This questionnaire is the first one inquiring into patients' body image disturbances that has been validated and is available in German.
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