Effect of Reading Rehabilitation for Age-Related Macular Degeneration on Cognitive Functioning: Protocol for a Nonrandomized Pre-Post Intervention Study
Authors: Wittich Walter , Pichora-Fuller M Kathleen , Johnson Aaron , Joubert Sven , Kehayia Eva , Bachir Vanessa , Aubin Gabrielle , Jaiswal Atul , Phillips Natalie 
Published: February 2021

Background
Age-related vision impairments and dementia both become more prevalent with increasing age. Research into the mechanisms of these conditions has proposed that some of their causes (eg, macular degeneration/glaucoma and Alzheimer’s disease) could be symptoms of an underlying common cause. Research into sensory-cognitive aging has provided data that sensory decline may be linked to the progression of dementia through reduced sensory stimulation. While hearing loss rehabilitation may have a beneficial effect on cognitive functioning, there are no data available on whether low vision rehabilitation, specifically for reading, could have a beneficial effect on cognitive health.

Objective
The research questions are: (1) Does low vision rehabilitation reduce reading effort? (2) If so, does reduced reading effort increase reading activity, and (3) If so, does increased reading activity improve cognitive functioning? The primary objective is to evaluate cognition before, as well as at 6 months and 12 months after, 3 weeks of low vision reading rehabilitation using magnification in individuals with age-related macular degeneration, with or without coexisting hearing impairments. We hypothesize that improvements postrehab will be observed at 6 months and maintained at 12 months for participants with vision loss and less so for those with dual sensory loss. The secondary objective is to correlate participant characteristics with all cognitive outcomes to identify which may play an important role in reading rehabilitation.

Methods
We employ a quasiexperimental approach (nonrandomized, pre-post intervention study). A 3x3 design (3 groups x 3 time points) allows us to examine whether cognitive performance will change before and after 6 months and 12 months of a low vision reading intervention, when comparing 75 low vision and 75 dual sensory impaired (vision & hearing) participants to 75 age-matched healthy controls. The study includes outcome measures of vision (eg, reading acuity and speed), cognition (eg, short-term and long-term memory, processing speed), participant descriptors, demographics, and clinical data (eg, speech perception in noise, mental health).

Results
The study has received approval, and recruitment began on April 24, 2019. As of March 4, 2021, 38 low vision and 7 control participants have been enrolled. Lockdown forced a pause in recruitment, which will recommence once the COVID-19 crisis has reached a point where face-to-face data collection with older adults becomes feasible again.

Conclusions
Evidence of protective effects caused by reading rehabilitation will have a considerable impact on the vision rehabilitation community and their clients as well as all professionals involved in the care of older adults with or without dementia. If we demonstrate that reading rehabilitation has a beneficial effect on cognition, the demand for rehabilitation services will increase, potentially preventing cognitive decline across groups of older adults at risk of developing macular degeneration.

Trial Registration
ClinicalTrials.gov NCT04276610; Unique Protocol ID: CRIR-1284-1217; https://clinicaltrials.gov/ct2/show/NCT04276610

International Registered Report Identifier (IRRID)
DERR1-10.2196/19931