Wittich Walter, Pichora-Fuller M Kathleen, Johnson Aaron, Joubert Sven, Kehayia Eva, Bachir Vanessa, Aubin Gabrielle, Jaiswal Atul, Phillips Natalie
School of Optometry, Université de Montréal, Montreal, QC, Canada.
Institut Nazareth et Louis-Braille du CISSS de la Montérégie-Centre, Longueuil, QC, Canada.
JMIR Res Protoc. 2021 Mar 11;10(3):e19931. doi: 10.2196/19931.
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.
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.
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).
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.
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.
ClinicalTrials.gov NCT04276610; Unique Protocol ID: CRIR-1284-1217; https://clinicaltrials.gov/ct2/show/NCT04276610.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19931.
与年龄相关的视力障碍和痴呆症都随着年龄增长而愈发普遍。对这些病症机制的研究表明，它们的某些病因（如黄斑变性/青光眼和阿尔茨海默病）可能是潜在共同病因的症状。对感觉认知老化的研究提供的数据表明，感觉衰退可能通过减少感觉刺激与痴呆症的进展相关联。虽然听力损失康复可能对认知功能有有益影响，但关于低视力康复，特别是阅读方面的康复，是否会对认知健康产生有益影响，目前尚无相关数据。
研究问题如下：（1）低视力康复是否能减少阅读难度？（2）如果是，阅读难度的降低是否会增加阅读活动？以及（3）如果是，阅读活动的增加是否会改善认知功能？主要目的是评估年龄相关性黄斑变性患者（无论是否伴有听力障碍）在接受为期3周的使用放大镜的低视力阅读康复训练之前、之后6个月和12个月时的认知情况。我们假设，视力丧失的参与者在康复后6个月会出现改善，并在12个月时保持，而双重感觉丧失的参与者改善程度较小。次要目的是将参与者特征与所有认知结果相关联，以确定哪些因素可能在阅读康复中发挥重要作用。
我们采用准实验方法（非随机、干预前后研究）。3×3设计（3组×3个时间点）使我们能够在将75名低视力参与者和75名双重感觉受损（视力和听力）参与者与75名年龄匹配的健康对照进行比较时，考察低视力阅读干预6个月和12个月前后认知表现是否会发生变化。该研究包括视力（如阅读敏锐度和速度）、认知（如短期和长期记忆、处理速度）、参与者描述、人口统计学和临床数据（如噪声中的言语感知、心理健康）等结果指标。
该研究已获得批准，并于2019年4月24日开始招募。截至2021年3月4日，已招募38名低视力参与者和7名对照参与者。封锁导致招募工作暂停，一旦新冠疫情危机达到可以再次与老年人进行面对面数据收集的阶段，招募工作将重新开始。
阅读康复产生保护作用的证据将对视力康复界及其客户以及所有参与照顾患有或未患痴呆症老年人的专业人员产生重大影响。如果我们证明阅读康复对认知有有益影响，康复服务的需求将会增加，这有可能预防有患黄斑变性风险的老年人群体的认知衰退。
ClinicalTrials.gov NCT04276610；唯一协议标识符：CRIR - 1284 - 1217；https://clinicaltrials.gov/ct2/show/NCT04276610。
国际注册报告标识符（IRRID）：DERR1 - 10.2196/19931。
