Eccentric Viewing Training for Age-Related Macular Disease: Results of a Randomized Controlled Trial (the EFFECT Study).

Purpose: Eccentric viewing training for macular disease has been performed for > 40 years, but no large studies including control groups have assessed the benefits of this training. The EFFECT (Eccentric Fixation From Enhanced Clinical Training) study is a large randomized controlled trial of 2 types of eccentric viewing training. Design: Randomized controlled trial. Participants: Two hundred adults with age-related macular disease. Methods: Participants were randomized to either of the following: (1) a control group; (2) a group receiving supervised reading support; (3) a group receiving 3 sessions of training to optimize the use of their own preferred retinal locus; or (4) a group receiving 3 sessions of biofeedback training of a theoretically optimal trained retinal locus. All participants received standard low-vision rehabilitation. Main Outcome Measures: The primary outcome was patient-reported visual task ability measured on the Activity Inventory instrument at goal level. Secondary outcomes included reading performance and fixation stability. Results: There was no difference between groups on change in task ability (F(3,174) = 1.48, P = 0.22) or on any of the secondary outcome measures. Visual acuity and contrast sensitivity fell in all groups, suggesting that disease progression outweighed any benefit of training. Conclusions: Eccentric viewing training did not systematically improve task ability, reading performance, or fixation stability in this study. Our results do not support the routine use of eccentric viewing training for people with progressing age-related macular disease, although this training may help people with end-stage disease. Rehabilitation of an inherently progressive condition is challenging. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Test-Retest Variability and Discriminatory Power of Measurements From Microperimetry and Dark Adaptation Assessment in People With Intermediate Age-Related Macular Degeneration - A MACUSTAR Study Report.

Purpose: The purpose of this study was to assess test-retest variability and discriminatory power of measures from macular integrity assessment (S-MAIA) and AdaptDx. Methods: This is a cross-sectional study of 167 people with intermediate age-related macular degeneration (iAMD), no AMD (controls; n = 54), early AMD (n = 28), and late AMD (n = 41), recruited across 18 European ophthalmology centers. Repeat measures of mesopic and scotopic S-MAIA average (mean) threshold (MMAT decibels [dB] and SMAT [dB]) and rod intercept time (RIT [mins]) at 2 visits 14 (±7) days apart were recorded. Repeat measures were assessed by Bland-Altman analysis, intra-class correlation coefficients (ICCs) and variability ratios. Secondary analysis assessed the area under the receiver operating characteristic curves (AUC) to determine the ability to distinguish people as having no AMD, early AMD, or iAMD. Results: Data were available for 128, 131, and 103 iAMD participants for the mesopic and scotopic S-MAIA and AdaptDx, respectively. MMAT and SMAT demonstrate similar test-retest variability in iAMD (95% confidence interval [CI] ICC of 0.79-0.89 and 0.78-0.89, respectively). ICCs were worse in RIT (95% CI ICC = 0.55-0.77). All tests had equivalent AUCs (approximately 70%) distinguishing between subjects with iAMD and controls, whereas early AMD was indistinguishable from iAMD on all measures (AUC = <55%). A learning effect was not seen in these assessments under the operating procedures used. Conclusions: MMAT, SMAT, and RIT have adequate test-retest variability and are all moderately good at separating people with iAMD from controls. Translational Relevance: Expected levels of test-retest variability and discriminatory power of the AdaptDx and MAIA devices in a clinical study setting must be considered when designing future trials for people with AMD.

Repeatability and Discriminatory Power of Chart-Based Visual Function Tests in Individuals With Age-Related Macular Degeneration: A MACUSTAR Study Report.

Importance: There is a need for validated clinical end points that are reliably able to quantify potential therapeutic effects of future treatments targeting age-related macular degeneration (AMD) before the onset of serious visual impairment. Objective: To assess the reliability and discriminatory power of 5 simple chart-based visual function (VF) tests as potential measures for clinical trial end points with regulatory and patient-access intention in intermediate AMD (iAMD). Design, Setting, and Participants: This international noninterventional study took place at 18 tertiary ophthalmology departments across Europe. Participants were recruited between April 2018 and March 2020 and were identified during routine clinical review. Participants with no AMD and early AMD were recruited from hospital staff, friends, and family of participants with AMD and via referrals from community ophthalmologists and optometrists. The repeatability and discriminatory power of 5 simple chart-based assessments of VF (best-corrected visual acuity [BCVA], low-luminance visual acuity [LLVA], Moorfields Acuity Test [MAT], Pelli-Robson Contrast Sensitivity [CS], and International Reading Speed Test [IReST]) were assessed in a repeated-measures design. VF assessments were performed on day 0 and day 14. Participants with early AMD, iAMD, late AMD, and no AMD were recruited. Main Outcomes and Measures: Intraclass correlation coefficients (ICCs) and Bland-Altman 95% limits of agreement (LoA) were computed to assess repeatability. Area under the receiver operating characteristic curves (AUCs) determined the discriminatory ability of all measures to classify individuals as having no AMD or iAMD and to differentiate iAMD from its neighboring disease states. Results: A total of 301 participants (mean [SD] age, 71 [7] years; 187 female participants [62.1%]) were included in the study. Thirty-four participants (11.3%) had early AMD, 168 (55.8%) had iAMD, 43 (14.3%) had late AMD, and 56 (18.6%) had no AMD. ICCs for all VF measures ranged between 0.88 and 0.96 when all participants were considered, indicating good to excellent repeatability. All measures displayed excellent discrimination between iAMD and late AMD (AUC, 0.92-0.99). Early AMD was indistinguishable from iAMD on all measures (AUC, 0.54-0.64). CS afforded the best discrimination between no AMD and iAMD (AUC, 0.77). Under the same conditions, BCVA, LLVA, and MAT were fair discriminators (AUC, 0.69-0.71), and IReST had poor discrimination (AUC, 0.57-0.61). Conclusions and Relevance: BCVA, LLVA, MAT, CS, and IReST had adequate repeatability in this multicenter, multiexaminer setting but limited power to discriminate between no AMD and iAMD. The prognostic power of these variables to predict conversion from iAMD to late AMD is being examined in the ongoing longitudinal part of the MACUSTAR study.

A Discussion of Commercially Available Intra-ocular Telescopic Implants for Patients with Age-Related Macular Degeneration.

Age-related macular degeneration (AMD) is the leading cause of visual impairment in the western world, causing significant reduction in quality of life. Despite treatment advances, the burden of visual impairment caused by AMD continues to rise. In addition to traditional low vision rehabilitation and support, optical and electronic aids, and strategies to enhance the use of peripheral vision, implantable telescopic devices have been indicated as a surgical means of enhancing vision. Here we examine the literature on commercially available telescopic devices discussing their design, mode of action, surgical procedure and published outcomes on visual acuity, quality of life, surgical complication rates and cost effectiveness data where available.Funding Article processing charges were funded by VisionCare Inc.

Patient and public preferences for health states associated with AMD.

PURPOSE: Health utility values suitable for calculating quality-adjusted life-years are increasingly used to assess the cost-effectiveness of treatments for age-related macular degeneration (AMD). In the United States, health utilities are usually derived from the patients' own valuation or modeled using visual acuity as a surrogate outcome. In the United Kingdom and throughout Europe, health utilities are derived from public valuations. Our aim was to test if utility values for health states associated with AMD elicited directly from patients were different from those calculated from public tariffs for health-related quality of life (HRQoL) questionnaires. METHODS: Generic preference-based HRQoL questionnaires (EQ-5D and SF-6D) and the time trade-off (TTO) and visual analog scale (VAS) valuation techniques were administered to a sample of UK patients with AMD (N = 60). Health utilities were calculated using standard general population tariffs for the patient EQ-5D and SF-6D health states and directly from patient TTO and VAS scores. RESULTS: Mean utilities derived from the public tariffs were significantly higher than from patients' valuation (mean [±SD], 0.613 (±0.275) for the EQ-5D and 0.628 (±0.114) for the SF-6D compared with 0.481 [±0.411] for the TTO and 56.7 [±21.8] for the VAS score; p < 0.001). The EQ-5D was not significantly different from the SF-6D (p > 0.6). Visual acuity in the better seeing eye was not associated with any utility measure (all r < 0.08; p > 0.2). CONCLUSIONS: Patient and public preferences for health states associated with AMD are different, with patients valuing their health state more severely than the public tariffs of commonly used HRQoL questionnaires. Visual acuity did not predict health utility using any measure, and therefore, care should be taken when using visual acuity as a surrogate measure for utility in health economic analyses.

The effect of low vision rehabilitation in diabetic eye disease: a randomised controlled trial protocol.

PURPOSE: Current research highlights a rising incidence of diabetes and its complications. Diabetic retinopathy is the leading cause of blindness within the working-age population of the United Kingdom. Increasing severity of retinopathy is associated with reduced visual function and participation in daily living. Only 8% of those referred to Moorfields Eye Hospital's low vision clinic have diabetic eye disease, a value less than prevalence figures for diabetes would predict. The lack of evidence for effectiveness of low vision intervention in this patient group could be responsible. Therefore, in line with CONSORT guidance, we present the methodology of the first randomised controlled trial to quantify the effect of low vision rehabilitation on people with diabetic eye disease. METHODS: One hundred participants were recruited into four retinopathy severity groups based on their diagnosis according to the English National Screening Programme Grading Protocol. Participants were randomised to either immediate intervention (1-2 weeks after enrollment) or delayed (control) intervention (3 months after enrollment). Intervention was a standard low vision assessment performed in a hospital clinic. The Activity Inventory (AI), was administered to all participants by telephone within 1 week of enrollment (before any intervention) and repeated at 3 and 6 months. RESULTS: One hundred participants (Type 1: 28, Type 2: 72; male: 62, female 38) have been recruited. Median habitual distance acuity was 0.19 logMAR (6/9, 20/30), with an interquartile range of 0.06-0.30 logMAR (6/7.5-6/12, 20/25-20/40). AI responses were scored by Rasch analysis, providing a measure of visual ability. Median baseline visual ability was 1.64 logits, with an interquartile range of 0.60-3.75 logits. Difference in mean change in visual ability between intervention groups will be assessed 3 months (primary outcome) and 6 months (secondary outcome) after enrollment. CONCLUSIONS: This is the first randomised controlled trial investigating the effectiveness of low vision rehabilitation for people with diabetic eye disease. With recruitment already complete, it is hoped this work will be the first step in guiding referral criteria for those with diabetic eye disease into the low vision service.

Fixation stability: a comparison between the Nidek MP-1 and the Rodenstock scanning laser ophthalmoscope in persons with and without diabetic maculopathy.

PURPOSE: Impaired fixation stability is associated with reduced reading speed. In previous research, fixation stability has been assessed using an infrared eye tracker or a confocal scanning laser ophthalmoscope. The new MP-1 microperimeter from Nidek Technologies (Padova, Italy) provides another option for the assessment of fixation. Here the authors compare fixation stability values measured using the MP-1 microperimeter and the Rodenstock scanning laser ophthalmoscope (SLO; Rodenstock GmbH, Munich, Germany) in persons with and without diabetic maculopathy. METHODS: Sixteen normally sighted volunteers and 21 patients with diabetic maculopathy were recruited. Fixation stability was recorded monocularly on the SLO and the MP-1 in counterbalanced order while participants fixated a red 1 degree cross. Fixation data collected from each instrument were used to calculate a bivariate contour ellipse area (BCEA) that encompassed 68% of fixation points. RESULTS: For control subjects, MP-1 BCEA values were larger than SLO by 0.25 log min arc(2), though the difference was small (10%) and of borderline significance (MP-1, 2.51 log min arc(2); SLO, 2.26 log min arc(2); P = 0.06). In patients with diabetic maculopathy there was no significant difference between MP-1 and SLO values (MP-1, 2.94 log min arc(2); SLO, 2.90 log min arc(2); P = 0.88). CONCLUSIONS: No significant difference was found in BCEA values from the SLO and MP-1 in control subjects and patients with diabetic maculopathy. The authors suggest that the similarity between BCEA values, together with the consistent and reliable operation of the MP-1, make it a useful and viable alternative to the SLO in the assessment of fixation.

Fixation stability measurement using the MP1 microperimeter.

PURPOSE: The Nidek microperimeter (MP1, Nidek Instruments, Italy) is a microperimetry device that also assesses fixation stability. The MP1 does not use the method of quantifying fixation stability by calculating a bivariate contour ellipse area (BCEA). Here we compare the MP1 fixation quantification with the BCEA technique by correlating these values to various parameters of reading known to be related to fixation stability. METHODS: Twenty-five people with age-related macular disease were assessed. Eye position was recorded using the MP1 during a fixation task. Fixation score and central 2 degrees and central 4 degrees values were obtained from the MP1. Bivariate contour ellipse area values were calculated from raw fixation data. Reading was assessed using MNREAD, Rapid Serial Visual Presentation, and European reading tests. RESULTS: Fixation data could not be collected for two observers. For the other 23 participants, the MP1 fixation scores were very poorly related to reading parameters. In contrast, there was a significant relationship between fixation stability assessed using the BCEA technique and Rapid Serial Visual Presentation reading speed (r = -0.59, P < 0.01), European reading test reading error rate (r = 0.66, P < 0.01), and MNREAD peak reading speed (r = 0.55, P < 0.05). CONCLUSION: Using the software supplied with the MP1 does not adequately quantify fixation stability in people with age-related macular disease. We recommend that the BCEA technique is used to quantify fixation stability when using the MP1 microperimeter.