Telerehabilitation for Low Vision

(BeST-AID Trial)

Recruiting at 9 trial locations

Overseen By UCLA Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Cognitive impairment, Substance abuse, Hearing loss, others

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: 14

Duration: 12 months

350 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{3 8 9 10 11}

Who Is on the Research Team?

Ava K Bittner, OD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Low Vision Rehabilitation

Trial Overview The 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.

How Is the Trial Designed?

Group I: Telerehabilitation with low vision provider Experimental Treatment 1 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-Office Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision. Bittner, AK., Kaminski, JE., Ross, NC., et al.[2023]

The LOVIT II trial is a multicenter randomized controlled trial involving 330 patients with macular disease, aiming to compare the effectiveness of low vision rehabilitation (LVR) with basic low vision (LV) services.

Preliminary results show that LVR, which includes therapy sessions to teach effective use of vision aids, may lead to better improvements in visual reading ability compared to basic LV, where devices are simply dispensed without additional training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. Stelmack, JA., Tang, XC., Reda, DJ., et al.[2015]

In a study of 1,000 patients with low vision, visual rehabilitation was successful in improving visual acuity for 98% of participants, highlighting its effectiveness for most ocular diseases.

However, patients with retinitis pigmentosa showed significantly lower success rates at only 46%, suggesting that this specific condition may require tailored approaches or improved visual aids for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of eye disease and adaptation of visual aids in low vision patients: review of 1,000 cases]. Fernández Guardiola, A., Sierra Jane, I.[2006]

The study demonstrated the feasibility of telerehabilitation for low vision users of eSight Eyewear, with high accessibility (93%) and overall satisfaction (100%) reported by participants who completed the program.

Despite a high withdrawal rate (35%) among participants, positive qualitative feedback indicated that telerehabilitation could enhance the use of head-mounted displays and improve daily activities for individuals with low vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Telerehabilitation for a Head-mounted Low Vision Aid: A Randomized Feasibility Study. Lorenzini, MC., Wittich, W.[2023]

Telerehabilitation services for individuals with vision impairment have shown high patient satisfaction and positive impacts on quality of life and daily activities, based on a review of 10 studies.

Despite the promising outcomes, there is a lack of comprehensive real-world data and completed clinical trials, indicating a need for further research to assess the long-term effectiveness and desirability of telerehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scoping review of remote rehabilitation (telerehabilitation) services to support people with vision impairment. Jones, L., Lee, M., Castle, CL., et al.[2022]

There is currently no evidence from randomized controlled trials comparing telerehabilitation to in-person vision rehabilitation services for individuals with low vision, highlighting a gap in research.

Given the significant number of people affected by low vision, future studies are needed to explore the feasibility and effectiveness of telerehabilitation as a means to improve vision-related quality of life and reading speed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation for people with low vision. Bittner, AK., Wykstra, SL., Yoshinaga, PD., et al.[2020]

Only 11.4% of patients with irreversible bilateral vision impairment and 1.9% with unilateral impairment were referred to low-vision rehabilitation services by ophthalmologists, indicating a significant gap in access to care.

Despite most patients expressing concern about their vision impairment and reporting difficulties in daily activities, there is a clear need for improved education among ophthalmologists regarding the importance of referring patients to low-vision rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Referral for Patients With Irreversible Vision Impairment Seen in a Public Safety-Net Eye Clinic. Coker, MA., Huisingh, CE., McGwin, G., et al.[2019]

This pilot study involving 10 visually impaired older adults demonstrated that telerehabilitation for low vision care is feasible and acceptable, with participants expressing satisfaction and comfort using videoconferencing for follow-up training.

After participating in telerehabilitation sessions, 8 out of 10 participants reported improved use of their magnification devices, indicating that this approach can effectively enhance reading ability and overcome barriers to in-person follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Telerehabilitation for Low Vision: Satisfaction Ratings by Providers and Patients. Bittner, AK., Yoshinaga, P., Bowers, A., et al.[2019]

The newly developed audiovisual telerehabilitation (AVT) system has shown promising results in improving visual detection abilities in three adult patients with visual field defects, indicating its potential efficacy.

This telerehabilitation approach allows therapists to remotely monitor and control training sessions, which could lead to significant cost savings and reduced hospital stays for patients with visual impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a New Telerehabilitation System for Audiovisual Stimulation Training in Hemianopia. Tinelli, F., Cioni, G., Purpura, G.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Interpretation of low-vision rehabilitation outcome measures. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision. [2023]

4. England pubmed.ncbi.nlm.nih.gov

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. [2015]

5. Spain pubmed.ncbi.nlm.nih.gov

[Analysis of eye disease and adaptation of visual aids in low vision patients: review of 1,000 cases]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Personalized Telerehabilitation for a Head-mounted Low Vision Aid: A Randomized Feasibility Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Scoping review of remote rehabilitation (telerehabilitation) services to support people with vision impairment. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Telerehabilitation for people with low vision. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation Referral for Patients With Irreversible Vision Impairment Seen in a Public Safety-Net Eye Clinic. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Telerehabilitation for Low Vision: Satisfaction Ratings by Providers and Patients. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Implementation of a New Telerehabilitation System for Audiovisual Stimulation Training in Hemianopia. [2020]