Association between Patient-Reported Outcomes and Time to Late Age-Related Macular Degeneration in the Laser Intervention in Early Stages of Age-Related Macular Degeneration Study.

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.

Properties of the Impact of Vision Impairment and Night Vision Questionnaires Among People With Intermediate Age-Related Macular Degeneration.

PURPOSE: To explore the psychometric properties of the Impact of Vision Impairment (IVI-28) and Night Vision Questionnaires (NVQ-10) among people with intermediate age-related macular degeneration (iAMD). METHODS: Baseline responses were collected from 288 participants (aged 50-88 years, 74% female) in the Laser intervention in Early stages of Age-related macular Degeneration (LEAD) study in Australia and Northern Ireland. Psychometric properties (discrimination, ordering of thresholds, person separation, item miss-fit, and differential item functioning according to sex) were explored using grouped rating scale and partial credit models. Spearman's correlation was estimated to assess the association with measures of visual function (mean mesopic microperimetric sensitivity, best-corrected visual acuity, low-luminance visual acuity, and low-luminance deficit). The psychometric properties were then explored following recalibration of the instruments. RESULTS: In this homogenous population, ceiling effects caused by relatively high levels of functional vision were evident for both instruments. The IVI-28 and NVQ-10 displayed suboptimal discrimination between levels of functional vision in iAMD and poor targeting among people with iAMD. The correlation between ability scores and measures of visual function was mild. In general, the NVQ-10 showed superior psychometric properties to the IVI-28 among these participants. No significant improvement in reliability could be gained following recalibration. CONCLUSIONS: Both instruments were designed for populations with more severe visual loss and poorly discriminate in this cohort of iAMD. TRANSLATIONAL RELEVANCE: New instruments that can capture the subtle changes in functional vision that occur early in AMD are required to aid evaluation of emerging interventions for iAMD.