Core outcomes for geographic atrophy trials

Background/AimsOngoing and recent clinical trials for geographic atrophy (GA) have used different outcomes. The goal of this study was to identify a core outcome set (COS) important for patients, clinicians and researchers, and to propose the use of COS in the design of future GA trials.MethodsFive-component project including: Delphi method with patients and experts, focus groups and interviews with patients, relatives and workers supporting patients. Three hundred and one patients (301) with age-related macular degeneration participated in round 1 of a Delphi exercise. Most subjects had GA; 183 patients (61%) were females and the median (range) age was 77 (50–99) years. In round 2, of the 301 of the first round, 100 participants were randomly selected of whom 76 agreed to take part. In a parallel Delphi exercise, panellists comprised a mix of non-clinical scientists and clinicians (43 in the initial and 21 in the final round). In addition, interviews and focus groups consisting of patients (n=20), family members (n=4) and support workers (n=5) were undertaken.ResultsCore outcomes identified as important for age-related macular degeneration trials were the health of the outer retina, multimodal estimation of lesion size, reading speed, best corrected distance and near acuity, low luminance visual acuity, patient reported visual performance and safety.ConclusionThis study identified a set of core outcomes that should be used in GA trials. The COS include patient-reported outcome measures, near visual acuity, reading speed and assessment of the outer retina.

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The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA LV VFQ-48): Performance of the Italian version

European Journal of Ophthalmology ◽

10.1177/1120672119852016 ◽

2019 ◽

Vol 30 (5) ◽

pp. 1014-1018

Author(s):

Ilaria Di Maggio ◽

Gianni Virgili ◽

Giovanni Giacomelli ◽

Vittoria Murro ◽

Giovanni Sato ◽

...

Keyword(s):

Visual Acuity ◽

Visual Information ◽

Low Vision ◽

Reading Speed ◽

Veterans Affairs ◽

Age Related Macular Degeneration ◽

Italian Version ◽

Visual Functioning ◽

Age Related ◽

Patient Reported

Purpose: The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 is among the most validated tools to collect patient-reported outcomes in a low-vision population. We have aimed to conduct a pilot validation of the Italian version of the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48. Methods: The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 was translated using a standardized procedure and then administered to consecutive low-vision patients attending rehabilitation services in three centers. Patients were interviewed by a trained psychologist regarding the individual items of the tool. Results: We included 131 patients with a mean visual acuity of 0.91 logMAR (standard deviation: 0.42 logMAR), mostly affected by age-related macular degeneration. The Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 showed high internal consistency (Cronbach’s alpha: 0.98) and good item-test and item-rest correlation (median: 0.73 and 0.71, respectively). Both the overall score and the subscale (reading, visual motor, mobility and visual information) scores significantly correlated with visual acuity, reading acuity and speed. Reading speed achieved the best absolute correlation with the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 scores (Spearman r: 0.39–0.49). Conclusion: The Italian version of the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 is a valid tool to assess patients attending low-vision services. Revising a few items may further improve the tool.

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Strongest Correlation Between Contrast Sensitivity and Morphological Characteristics in Bilateral nAMD

Frontiers in Medicine ◽

10.3389/fmed.2020.622877 ◽

2021 ◽

Vol 7 ◽

Author(s):

Laura Hoffmann ◽

Petra Rossouw ◽

Maria-Magdalena Guichard ◽

Katja Hatz

Keyword(s):

Visual Acuity ◽

Contrast Sensitivity ◽

Reading Speed ◽

Fundus Autofluorescence ◽

Optical Tomography ◽

Morphological Characteristics ◽

Geographic Atrophy ◽

Age Related Macular Degeneration ◽

Function Parameter ◽

Age Related

In patients with neovascular age-related macular degeneration (nAMD) there is often an inconsistency between their subjective visual impairment and a still relatively preserved standard Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity. Therefore, in order to better capture the specific functional defects in nAMD, other tests need to be evaluated. In a previous study, we reported contrast sensitivity of the better eye to best correlate with near distance and distance vision related quality of life in patients with bilateral nAMD. Here, we evaluated Pelli-Robson contrast sensitivity, ETDRS visual acuity, low luminance visual acuity and Radner maximum reading speed and correlated them with several morphologic parameters as measured on fundus autofluorescence imaging, optical coherence tomography and optical tomography angiography in 54 patients. A multiple regression analysis was performed which correlated each visual function parameter with the anatomic features. The results showed the strongest correlations between the total area of macular geographic atrophy as well as the percentage of geographic atrophy in the central 1 mm and contrast sensitivity. Further, the regression model selected the total area of macular geographic atrophy, the photoreceptor inner and outer segments interface disruption score, the presence of subretinal fibrosis in the central 1 mm and the central retinal thickness as the variables that explained 71% of the variation in contrast sensitivity when including all eyes. Hence, our results suggest that among the evaluated measures of vision, contrast sensitivity is best correlated with the morphologic impairment in bilateral nAMD. Thus, contrast sensitivity may complement ETDRS visual acuity in clinical trials and serve as a standard diagnostic tool in clinical practice.

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Maximum Reading Speed in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Investigative Opthalmology & Visual Science ◽

10.1167/iovs.18-24238 ◽

2018 ◽

Vol 59 (4) ◽

pp. AMD195 ◽

Cited By ~ 3

Author(s):

Rohit Varma ◽

Eric H. Souied ◽

Adnan Tufail ◽

Elizabeth Tschosik ◽

Daniela Ferrara ◽

...

Keyword(s):

Macular Degeneration ◽

Reading Speed ◽

Geographic Atrophy ◽

Age Related Macular Degeneration ◽

Age Related

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Percentage of Foveal versus Total Macular Geographic Atrophy as a Predictor of Visual Acuity in Age-related Macular Degeneration

10.1101/544254 ◽

2019 ◽

Author(s):

Saghar Bagheri ◽

Ines Lains ◽

Rebecca Silverman ◽

Ivana Kim ◽

Dean Eliott ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Fundus Autofluorescence ◽

Cross Sectional Study ◽

Geographic Atrophy ◽

Age Related Macular Degeneration ◽

Cross Sectional ◽

Age Related ◽

The Impact ◽

Foveal Sparing

AbstractObjectivesTo investigate the relationship between visual acuity (VA), total area of geographic atrophy (GA) and percentage of foveal GA.MethodsMulticenter, retrospective cross-sectional study of patients with GA due to age-related macular degeneration. Demographics, VA, fundus autofluorescence (FAF) and optical coherence tomography (OCT) images were collected. Using FAF images aided by OCT, foveal sparing status, GA pattern, total GA size, and percentage of GA covering the foveal area - area within a 1.5 mm diameter circle centered on the fovea centralis - were assessed. Univariable and multiple linear regression analyses were performed.Results54 eyes (mean age 78.7 ±7.7 (SD), 60.0% female) were studied. Mean VA was 0.8 ± 0.6 logMAR, mean total GA 8.8 ± 6.7 mm2 and mean percentage of foveal GA was 71.5 ± 30.9%. Of all assessed eyes, 48.2% (n = 26) presented with multifocal GA, and 18.5% (n = 10) had foveal sparing. Multiple regression analysis revealed that, controlling for age and GA pattern, the percentage of foveal GA presented a statistically significant association with VA (ß = 0.41, P = 0.004). No significant associations were observed with mean total GA size, while controlling for the same variables (ß = 0.010, P = 0.440).ConclusionPercentage of foveal GA was significantly associated with VA impairment, while the same was not verified for total GA area. These findings suggest that percentage of foveal GA may represent a more useful tool for assessing the impact of GA on VA. Further validation is needed in larger cohorts.

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Foveal-Sparing Scotomas in Advanced Dry Age-Related Macular Degeneration

Journal of Visual Impairment & Blindness ◽

10.1177/0145482x0810201004 ◽

2008 ◽

Vol 102 (10) ◽

pp. 600-610 ◽

Cited By ~ 43

Author(s):

Janet S. Sunness ◽

Gary S. Rubin ◽

Abraham Zuckerbrod ◽

Carol A. Applegate

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Geographic Atrophy ◽

Age Related Macular Degeneration ◽

Good Visual Acuity ◽

Age Related ◽

Foveal Sparing

Foveal-sparing scotomas are common in advanced dry macular degeneration (geographic atrophy). Foveal preservation may be present for a number of years. Despite good visual acuity, these patients have reduced reading rates. Magnification may not be effective if the text becomes too large to “fit” within the central spared area.

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Vision Rehabilitation in Patients with Age-related Macular Degeneration

Rehabilitation Process and Outcome ◽

10.4137/rpo.s12364 ◽

2014 ◽

Vol 3 ◽

pp. RPO.S12364 ◽

Cited By ~ 1

Author(s):

Filippo M. Amore ◽

Stefania Fortini ◽

Valeria Silvestri ◽

Marco Sulfaro ◽

Alessia Pacifici ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Visual Stimulation ◽

Low Vision ◽

Reading Speed ◽

Age Related Macular Degeneration ◽

International Agency ◽

Visual Rehabilitation ◽

Age Related ◽

Fixation Stability

Background The aim of this study was to investigate the rehabilitative process and visual rehabilitation outcomes in patients with central vision loss due to age-related macular degeneration (AMD). Methods Ninety-five subjects with AMD selected from the attendees of the National Centre of Services and Research for the Prevention of Blindness and Rehabilitation of Low Vision Patients—International Agency for Prevention of Blindness—IAPB Italia Onlus, were evaluated for this retrospective study. Low vision examination included psychological counseling, best corrected visual acuity (BCVA), near visual acuity, Pelli-Robson contrast sensitivity, and fixation stability analysis. Once the clinical assessment was completed, patients attended a low-vision rehabilitative pathway based on visual stimulation, devices training and, if needed, psychological support. Required magnification and reading speed were also evaluated. Results For the whole sample, the mean BCVA of the better eye was 0.7 (±0.2) LogMAR and of the worse eye was 1 (±0.2) LogMAR. Restoring reading ability was the most important focus for the patients examined as it was requested by 85% of the whole sample. Mean power of optical magnifying aids for near activities was 10.6 (±9.1) positive spherical diopters. Mean reading speed for the whole sample was 33.1 (±18.2) words per minute (wpm) before visual rehabilitation sessions and increased to 55.2 (±33.1) wpm after visual rehabilitation path. To cope with distance difficulties, 78 distance refractive correction, 10 Galilean telescopes, and 7 Keplerian telescopes were prescribed. For intermediate distance activities, 22 compensation lenses and 10 Galilean telescopes were suggested. Moreover, PC magnifier softwares were prescribed to nine patients. Sixty-five polarized medical filters were prescribed to reduce glare of sunlight. Because of unstable fixation in their better eye (32.3% (±19.7) within 2° circle and 54.8% (±22.9) within 4° circle) and visual acuity < 1.2 LogMAR in the fellow eye, 38 subjects, before starting the devices training sessions, attended a bio-feedback rehabilitation session with flickering pattern stimulus. In these subjects, fixation stability increased significantly to 75.6 (±14.9) within 2° and 89.4 (±19.5) within 4° ( P < 0.05), respectively. Conclusions Attending a customized low-vision intervention based on a multidisciplinary approach seems to be effective for improving visual functions in AMD. Both optical/electronic magnifiers and specific visual stimulation program can enhance visual performances.

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Exploratory Study on Visual Acuity and Patient-Perceived Visual Function in Patients with Subretinal Drusenoid Deposits

Journal of Clinical Medicine ◽

10.3390/jcm9092832 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2832

Author(s):

Manjot K. Grewal ◽

Shruti Chandra ◽

Sarega Gurudas ◽

Alan Bird ◽

Glen Jeffery ◽

...

Keyword(s):

Visual Acuity ◽

Disease Severity ◽

Visual Function ◽

Healthy Aging ◽

Geographic Atrophy ◽

Age Related Macular Degeneration ◽

Function Tests ◽

Age Related ◽

Low Luminance ◽

Subretinal Drusenoid Deposits

Purpose: To investigate the value of visual acuity and patient-perceived visual function test when subretinal drusenoid deposits (SDD) are incorporated into the classification of age-related macular degeneration (AMD). A total of 50 participants were recruited into the study in these groups: healthy ageing (n = 11), intermediate AMD (iAMD) with no SDD (n = 17), iAMD with SDD (n = 11) and non-foveal atrophic AMD (n = 11) confirmed by two retinal imaging modalities. Best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) were measured and low luminance deficit (LLD) was calculated. Participants were also interviewed with the low luminance questionnaire (LLQ). Linear regression was used to assess function–function relations. Compared with healthy participants, BCVA and LLVA scores were significantly reduced in the atrophic AMD group (p < 0.0001 and p = 0.00016, respectively) and in patients with SDD (p = 0.028 and p = 0.045, respectively). Participants with atrophy also had reduced BCVA (p = 0.001) and LLVA (p = 0.009) compared with the iAMD no SDD group. However, there were no differences in visual function tests between healthy aging and iAMD without SDD and between iAMD with SDD and atrophic AMD groups. The LLD score did not differ between groups. BCVA and LLVA correlated well. The LLQ did not correlate with visual function tests. This study shows that LLD is not a marker of disease severity as assessed clinically. Although LLQ is a good marker for disease severity using the current AMD classification, it does not differentiate between eyes with and without SDD. Eyes with non-macular geographic atrophy and SDD had lower function than eyes with no SDD and healthy controls.

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Correlation between Visual Functions and Retinal Morphology in Eyes with Early and Intermediate Age-Related Macular Degeneration

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17176379 ◽

2020 ◽

Vol 17 (17) ◽

pp. 6379

Author(s):

Rituparna Ghoshal ◽

Sharanjeet Sharanjeet-Kaur ◽

Norliza Mohamad Fadzil ◽

Haliza Abdul Mutalib ◽

Somnath Ghosh ◽

...

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Layer Thickness ◽

Reading Speed ◽

Retinal Pigment ◽

Age Related Macular Degeneration ◽

Morphological Alteration ◽

Retinal Layer ◽

Visual Functions ◽

Age Related

In early and intermediate age related macular degeneration (ARMD), visual acuity alone has failed to explain the complete variation of vision. The aim of the present study was to determine correlation between different visual functions and retinal morphology in eyes with early and intermediate ARMD. In this single center cross sectional study, patients diagnosed as early or intermediate ARMD in at least one eye were recruited. Visual functions measured were best- corrected distance visual acuity (DVA), near vision acuity (NVA), reading speed (RS), and contrast sensitivity (CS). Parameters such as thickness (RT) and volume (RV) of the retina, outer retinal layer thickness (ORLT) and volume (ORLV), outer nuclear layer thickness (ONLT) and volume (ONLV), retinal pigment epithelium layer-Bruch’s membrane complex thickness (RPET) and volume (RPEV) were assessed employing semi-auto segmentation method of Spectralis optical coherence tomography (OCT). Twenty-six eyes were evaluated. DVA, CS, and RS showed significantly good correlation with RPET, ONLT, and ONLV, whereas NVA showed good correlation with ONLV and RPET. The present study concluded that RS, CS, NVA, and DVA represent the morphological alteration in early stages and should be tested in clinical settings. ONLT, ONLV, and RPET morphological parameters can be employed as important biomarkers in diagnosis of early to intermediate ARMD.

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