350 Participants Needed

Telerehabilitation for Low Vision

(BeST-AID Trial)

Recruiting at 9 trial locations
NC
US
Overseen ByUCLA Study Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services.

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 focused on vision rehabilitation, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment for low vision rehabilitation?

Research suggests that telerehabilitation, which involves remote therapy sessions, can help improve reading ability in people with low vision by using magnification devices. This approach can make it easier for patients to access follow-up care and potentially enhance their visual skills.12345

Is telerehabilitation for low vision safe for humans?

The available research does not specifically address safety concerns, but telerehabilitation for low vision is generally considered feasible and aims to improve access to care, suggesting it is safe for use in humans.36789

How is telerehabilitation for low vision different from other treatments?

Telerehabilitation for low vision is unique because it allows patients to receive rehabilitation services remotely, using technology to improve reading ability and access to care without needing to travel. This approach is particularly beneficial for those with limited access to providers and helps overcome transportation barriers.3671011

Research Team

AK

Ava K Bittner, OD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adults over 18 with any level of vision loss from ocular disease, who've just received new magnification devices or visual assistive apps. It's not for those with conflicting schedules, substance abuse issues, severe hearing loss, major health conditions limiting participation or lifespan, communication difficulties regarding visual stimuli, need other low vision training, or have incompatible device features.

Inclusion Criteria

I am 18 or older with vision loss from an eye condition.
You use special devices like magnifiers or smartphone apps to help you see better.
Received new magnification device(s) for the first time from one of the participating low vision rehabilitation sites at the specified centers

Exclusion Criteria

I can understand and respond to study procedures and visual stimuli.
I have significant hearing loss.
Significant medical condition likely to limit participation or lifespan
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low vision rehabilitation through either in-office care or telerehabilitation using magnification devices and visual assistive mobile apps

12 months
Regular sessions over 1 to 8 months, with follow-up at 1 year

Follow-up

Participants are monitored for adherence to device use and satisfaction with rehabilitation services

1 month
Final assessment at 13 months

Treatment Details

Interventions

  • Low Vision Rehabilitation
Trial OverviewThe study compares telerehabilitation to in-office care for follow-up training on using magnification devices and mobile apps to improve daily life activities. It also tests if beacon sensors can detect when patients stop using their low vision aids to prompt timely rehabilitation services.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Telerehabilitation with low vision providerExperimental Treatment1 Intervention
Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care
Group II: Usual Care In-OfficeActive Control1 Intervention
Low Vision Rehabilitation in-office for use of magnification or visual assistive devices

Low Vision Rehabilitation is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Low Vision Rehabilitation for:
  • Low vision due to various causes including age-related macular degeneration, diabetic retinopathy, glaucoma, and other conditions leading to visual impairment
🇪🇺
Approved in European Union as Low Vision Rehabilitation for:
  • Visual impairment due to various ophthalmological conditions, including but not limited to macular degeneration, diabetic retinopathy, and glaucoma
🇨🇦
Approved in Canada as Low Vision Rehabilitation for:
  • Low vision resulting from conditions such as age-related macular degeneration, diabetic retinopathy, and other causes of visual impairment

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Southern California College of Optometry at Marshall B. Ketchum University

Collaborator

Trials
24
Recruited
1,400+

University of Nebraska

Collaborator

Trials
563
Recruited
1,147,000+

New England College of Optometry

Collaborator

Trials
11
Recruited
13,100+

Mid-Michigan Eye Care

Collaborator

Trials
1
Recruited
350+

Findings from Research

In a study of 779 patients undergoing low vision rehabilitation (LVR) across 28 clinical centers, nearly half (47%) showed clinically meaningful improvements in overall visual ability after 6 to 9 months of rehabilitation.
The largest effect size was observed in overall visual ability (Cohen d = 0.87), indicating significant benefits from LVR, with age and visual acuity being important predictors of improvement.
Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers.Goldstein, JE., Jackson, ML., Fox, SM., et al.[2020]
Patient-reported outcomes in low-vision rehabilitation (LVR) reflect the difference between a patient's visual ability and the demands of specific tasks, indicating that improving functional reserve can be achieved through medical or assistive interventions.
To accurately measure the effectiveness of LVR interventions, it is crucial to select appropriate outcome measures that align with the intervention goals and the patients' impairment levels, filtering out items that already receive high positive ratings to avoid skewing results.
Interpretation of low-vision rehabilitation outcome measures.Massof, RW., Stelmack, JA.[2022]
A pilot study involving 14 adults with low vision showed that telerehabilitation training significantly improved reading acuity and speed when using new magnification devices, indicating its potential efficacy as a treatment method.
After two training sessions via telerehabilitation, 71% of participants experienced improved reading acuity, and all participants who increased their reading speed also showed gains in acuity, suggesting that remote training can effectively enhance reading abilities for individuals with low vision.
Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision.Bittner, AK., Kaminski, JE., Ross, NC., et al.[2023]

References

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. [2020]
Interpretation of low-vision rehabilitation outcome measures. [2022]
Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision. [2023]
VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. [2015]
[Analysis of eye disease and adaptation of visual aids in low vision patients: review of 1,000 cases]. [2006]
Personalized Telerehabilitation for a Head-mounted Low Vision Aid: A Randomized Feasibility Study. [2023]
Scoping review of remote rehabilitation (telerehabilitation) services to support people with vision impairment. [2022]
Telerehabilitation for people with low vision. [2020]
Rehabilitation Referral for Patients With Irreversible Vision Impairment Seen in a Public Safety-Net Eye Clinic. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Feasibility of Telerehabilitation for Low Vision: Satisfaction Ratings by Providers and Patients. [2019]
Development and Implementation of a New Telerehabilitation System for Audiovisual Stimulation Training in Hemianopia. [2020]