Occupational Therapy for Age-Related Macular Degeneration

Overseen By Michelle Dowling, OTD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: MCPHS University

Disqualifiers: Other age related eye diseases

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether certain strategies, such as better lighting and smart apps, can help people with low vision manage their medications more effectively. It focuses on individuals with age-related macular degeneration (AMD), diabetic retinopathy (DR), or glaucoma. Participants will receive Occupational Therapy Interventions for Low Vision Care, which includes personalized guidance on using these tools to improve medication management. This trial may benefit those who struggle with medication tasks due to vision issues from these eye conditions. As an Early Phase 1 trial, the research aims to understand how these strategies work in people, offering participants a chance to be among the first to explore innovative solutions for managing medication with low vision.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on improving how you manage your medications rather than changing them.

What prior data suggests that these occupational therapy interventions are safe for improving medication management skills?

Research has shown that occupational therapy for low vision is generally safe and manageable. These therapies often involve teaching methods such as using brighter lights and larger text to help individuals with vision issues manage daily activities more effectively. Reports of negative effects from these therapies are rare, as they focus on teaching skills and using simple tools rather than medical treatments. Therefore, participants can expect a low risk of side effects from this type of therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using occupational therapy (OT) interventions for age-related macular degeneration (AMD) because they offer a hands-on approach that focuses on enhancing daily living skills for those with low vision, rather than just addressing the eye condition itself. Unlike standard treatments like anti-VEGF injections or laser therapy, which target the physical aspects of AMD, OT interventions empower patients by teaching them adaptive techniques and using assistive devices to maintain their independence. This holistic approach can transform how individuals with AMD navigate their world, potentially improving quality of life beyond what current medical treatments can offer.

What evidence suggests that these occupational therapy interventions are effective for improving medication management skills in individuals with age-related macular degeneration?

Research has shown that occupational therapy can help people with age-related macular degeneration (AMD) manage daily tasks more easily. In this trial, all participants will receive occupational therapy interventions for low vision care. Studies have found that low vision therapy, which includes special lighting, larger print, and smart apps, can improve the ability to perform everyday activities. For example, one study found that these tools help individuals maintain important routines, like reading or managing medications, by maximizing their remaining vision. Another study demonstrated that learning to use low vision devices and strategies improved visual function in people with AMD. These findings suggest that occupational therapy effectively aids those with low vision in managing their daily lives. ^{1 4 5 6 7}

Who Is on the Research Team?

Michelle Dowling, OTD

Principal Investigator

MCPHS University

Are You a Good Fit for This Trial?

This trial is for individuals with Age-Related Macular Degeneration (AMD) who are receiving eye care services at the MCPHS School of Optometry in Worcester. Participants will allow their anonymous data to be used for research and are interested in learning how certain strategies might improve their medication management.

Inclusion Criteria

I have AMD and am getting eye care at MCPHS Worcester.

I agree to let my anonymous data be used for research.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a one-hour occupational therapy session focusing on education about task lighting, enhanced contrast, enlarged print instructions, smart apps, and organizational strategies to improve medication management skills.

1 day

1 visit (in-person)

Follow-up

Participants are reassessed for the effectiveness of interventions provided, using the MediCog and R-SRAFVP assessment tools.

4 weeks

1 visit (phone or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Occupational Therapy Interventions for Low Vision Care

Trial Overview

The study tests if occupational therapy interventions like additional lighting, enhanced contrast, enlarged print instructions, smart apps, and organizational strategies can help people with AMD manage medications better and make more effective use of their vision.

How Is the Trial Designed?

Group I: Receiving OT interventions Experimental Treatment 1 Intervention

All participants will receive all OT interventions

Occupational Therapy Interventions for Low Vision Care is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Occupational Therapy for:

• Improvement of medication management skills in individuals with visual impairments such as AMD

Approved in Canada as Occupational Therapy for:

• Enhancement of daily living activities including medication management for visually impaired individuals

Approved in European Union as Occupational Therapy for:

• Support for individuals with visual impairments to manage medications effectively

Who Is Running the Clinical Trial?

MCPHS University

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

Occupational therapy practitioners (N = 34) in low vision rehabilitation reported using a mix of self-designed and standardized assessments, indicating a flexible approach to evaluating clients' needs.

The majority of services are provided to older adults, with practitioners emphasizing the importance of continuing education and collaboration with other low vision professionals for effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from a survey of occupational therapy practitioners in low vision rehabilitation. Copolillo, A., Warren, M., Teitelman, JL.[2013]

In a study of 131 older adults with age-related macular degeneration (AMD), those in a health promotion program used low vision assistive devices (AD) more effectively alongside daily living devices compared to those in an individual program.

Despite increased use of non-optical AD and ADL devices, there was no significant link between the number of low vision AD used and changes in dependence levels over 28 months, suggesting that simply using more devices does not guarantee improved daily living performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low vision, ADL and hearing assistive device use among older persons with visual impairments. Eklund, K., Dahlin-Ivanoff, S.[2019]

In a study of 188 patients with age-related macular degeneration, combining behavioral activation with low vision rehabilitation led to greater improvements in functional vision compared to supportive therapy alone, particularly in reading and daily tasks.

Patients receiving the combined treatment showed the most significant benefits when their visual acuity was better than 20/70, suggesting that this approach is especially effective for those with mild visual impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Deemer, AD., Massof, RW., Rovner, BW., et al.[2018]

The Revised Low Vision Independence Measure (LVIM-R) effectively detects improvements in visual ability after occupational therapy, showing significant increases in scores for both visual field and visual acuity in a study of 44 participants with an average age of 80.2 years.

The LVIM-R can be reliably used in both home health and outpatient settings to assess the effectiveness of low vision rehabilitation, making it a valuable tool for occupational therapists working with elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsiveness of the Revised Low Vision Independence Measure (LVIM-R). Smith, TM., Hong, I., Reistetter, TA.[2022]

Occupational therapists frequently adjusted their interventions for clients with low vision to account for additional chronic conditions, implementing strategies like increased treatment sessions and referrals to other professionals.

Older adults with low vision perceived their vision loss as having a greater impact on their daily independence than their comorbid conditions, highlighting the need for targeted interventions that prioritize vision-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client and therapist perspectives on the influence of low vision and chronic conditions on performance and occupational therapy intervention. Barstow, BA., Warren, M., Thaker, S., et al.[2015]

In a study of 100 older adults (ages ≥55) in subacute rehabilitation, worse vision, specifically poor contrast sensitivity, was linked to less time spent in occupational therapy, suggesting that vision impairment can limit therapy utilization.

Additionally, lower visual acuity was associated with greater functional dependency at discharge, indicating that vision issues may reduce the effectiveness of occupational therapy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of vision impairment on intensity of occupational therapy utilization and outcomes in subacute rehabilitation. Cimarolli, VR., Morse, AR., Horowitz, A., et al.[2019]

Age-related macular degeneration (ARMD) is becoming more common in the aging U.S. population, leading to significant vision loss that can affect independence and quality of life.

Low vision rehabilitation techniques, focusing on magnification, contrast, and illumination, are essential for improving visual function and helping individuals regain independence despite ARMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision rehabilitation of persons with age related macular degeneration. Siemsen, DW., Brown, WL.[2019]

Low vision is a prevalent issue among the elderly, significantly impacting their independence and health, ranking just behind arthritis and heart disease as a cause of functional impairment in individuals over 70.

While laser therapy can help postpone vision loss from macular degeneration, the best approach for managing low vision includes using vision-enhancing devices, adaptive equipment, and education, often leading to improved quality of life through tailored rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of age-related visual impairment on functional independence in the elderly. Swagerty, DL.[2007]

The AOTA Evidence-Based Practice Project has created a comprehensive table that summarizes research opportunities for occupational therapy interventions aimed at older adults with low vision, highlighting the current state of evidence.

This resource is designed to assist researchers, students, and clinicians in developing innovative studies to address key questions in occupational therapy, promoting evidence-based practices in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research opportunities in the area of older adults with low vision. [2013]

Multicomponent interventions that teach older adults with low vision essential skills and knowledge are highly effective in helping them maintain independence in daily activities at home, based on a systematic review of 17 studies.

Personalized multidisciplinary interventions that focus on individual goals lead to better outcomes compared to non-personalized approaches, highlighting the importance of tailored support for older adults with vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy interventions to improve performance of daily activities at home for older adults with low vision: a systematic review. Liu, CJ., Brost, MA., Horton, VE., et al.[2019]

The systematic review on occupational therapy for older adults with low vision highlights effective interventions that can improve functional independence in this population, particularly for those with age-related macular degeneration.

The Evidence Connection articles demonstrate how research findings can be applied to real clinical cases, helping occupational therapists make informed decisions based on the latest evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy Interventions for Older Adults With Low Vision. Smallfield, S., Kaldenberg, J.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12033435/

Low vision home therapy service by occupational therapists

The study (Reeves, 2004) only included participants with age-related macular degeneration and the visual rehabilitation officer focused on the use of low vision ...

2.

ovid.com

ovid.com/journals/ajot/pdf/10.5014/ajot.2013.007203~effectiveness-of-occupational-therapy-interventions-for

Effectiveness of Occupational Therapy Interventions for ...

An 85-yr-old woman with macular degeneration struggles to read the daily newspaper, an important part of her morning routine. A 78-yr-old man with glaucoma ...

3.

research.aota.org

research.aota.org/ajot/article/74/1/7401185010p1/6654/Interventions-Within-the-Scope-of-Occupational

Interventions Within the Scope of Occupational Therapy ...

Common components of such programs include education about age-related macular degeneration, training in the use of low vision devices, training ...

4.

dc.uthsc.edu

dc.uthsc.edu/context/mot2/article/1003/filename/0/type/additional/viewcontent/66239259_77748080_Effects_of_OT_in_Low_Vision.pdf

Effects of Therapeutic Intervention on Low Vision By

rehabilitation with an occupational therapist (OT-LVR) with supportive therapy (ST) on visual function in patients with age-related macular degeneration (AMD).

5.

researchrepository.wvu.edu

researchrepository.wvu.edu/cgi/viewcontent.cgi?article=13094&context=etd

Occupational Therapy's Role in Low Vision Throughout the ...

Common causes of low vision include age-related macular degeneration, cataracts, diabetic retinopathy, and glaucoma. While there is a higher ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7018456/

Occupational Therapy Interventions to Improve Reading ...

ADLs = activities of daily living; AMD = age-related macular degeneration; AVT = audiovisual stimulation training; CCTV = closed-circuit television; COPM = ...

7.

ww2.jacksonms.gov

ww2.jacksonms.gov/browse/RZZZN5/1OK035/occupational_therapy-low_vision-interventions.pdf

Occupational Therapy Low Vision Interventions

diversity of low vision conditions such as age-related macular degeneration, glaucoma, ... impairments, such as AMD and cataract; peripheral field ...