Vision Impairment in Low Luminance Reports and Progression of Intermediate Age-Related Macular Degeneration in the MACUSTAR Study Cohort

Abstract

Purpose : To investigate the association of the Vision Impairment in Low Luminance (VILL) questionnaire with structural progression from intermediate to late age-related macular degeneration (AMD) in the prospective European multi-center cohort study MACUSTAR. The VILL has shown to be internally consistent, test-retest reliable; content, construct and criterion valid.

Methods : The 33-item VILL questionnaire was administered in the longitudinal part of the MACUSTAR study, following a specifically developed manual, besides other functional, structural, and patient-reported assessments. Data were analyzed using Rasch models and person measures were generated for the previously established and validated subscales: Reading and accessing information (VILL_R); mobility and safety (VILL_M); and emotional well-being (VILL_E). Time-discrete hazard models with a complementary log-log link function were used to investigate the association of VILL subscale scores at baseline as well as 12-month changes in VILL scores with the progression to late AMD (Beckman classification) over a median follow up of 3 years. Covariates included in the models were age at baseline, the presence of reticular pseudodrusen (RPD) and pointwise standard deviation on mesopic microperimetry (mesPSD), in line with the primary endpoint model of the MACUSTAR study.

Results : A total of 585 individuals with intermediate AMD were included in the analysis (mean age 72±7 years, 66% female, 27% with RPD, mean mesPSD 2.8±1.5 dB). Mean VILL-scores at baseline were 2.4±1.8 (VILL_R), 2.4±2.0 (VILL_M) and 2.1±3.2 logits (VILL_E). Lower VILL_R subscale scores at baseline were significantly associated with a higher risk of progression to late-stage AMD (β=0.78, p=0.01). A 12-month decline in VILL_M subscale scores was borderline associated with a higher risk of progression to late AMD (β=0.83, p=0.06), which was significant when considering only age and RPD as covariates (β=0.80, p=0.02).

Conclusions : The longitudinal data from the MACUSTAR study suggest that VILL questionnaire scores are prognostic of progression of AMD beyond the presence of known structural and functional risk factors. This suggests the potential use of patient-reported data as enrichment factors for interventional AMD trials. Our results further support that the VILL is an appropriate patient-reported outcome measure for use in future AMD trials.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.