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?

This trial compares two methods of follow-up care for individuals with low vision using magnification devices: traditional in-office visits and remote telerehabilitation via video calls. The researchers aim to determine if telerehabilitation is equally effective in helping individuals manage daily activities like reading. Additionally, the trial explores the use of Bluetooth sensors to monitor device usage, potentially enhancing support. The study seeks adults who have recently begun using magnifiers or visual assistive apps due to vision loss from any eye condition. As an unphased trial, it offers a unique opportunity to contribute to innovative care methods for 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 focused on vision rehabilitation, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that telerehabilitation for low vision is safe?

Research has shown that telerehabilitation for people with low vision is safe. This method uses video calls to help patients learn to use visual aids at home. Studies have confirmed its safety and effectiveness. For instance, one study used special questionnaires to ensure participants did not experience negative effects, such as feeling sick from the technology. Additionally, thorough vision checks conducted after standard low-vision tests support the treatment's safety. These findings suggest that telerehabilitation is a well-accepted option for those with low vision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the traditional in-office low vision rehabilitation, which involves face-to-face sessions for using magnification or visual assistive devices, telerehabilitation offers a fresh approach by delivering follow-up care remotely via videoconferencing. This method is unique because it provides convenience and accessibility, allowing patients to receive necessary care without the need to travel. Researchers are excited because this could significantly enhance access to care for individuals with low vision, especially those with mobility challenges or living in remote areas. By bridging the gap between patients and providers, telerehabilitation has the potential to make vision rehabilitation more efficient and widespread.

What evidence suggests that telerehabilitation is effective for low vision?

Research has shown that telerehabilitation, which participants in this trial may receive, can effectively help people with low vision improve their sight. One study found that using video calls for care worked just as well as visiting the office for training with magnifying tools. Other studies have demonstrated that it can help people read better and faster, making it a good alternative to traditional in-person sessions. This method allows people to receive care without traveling, which is especially helpful for those living far from clinics. Overall, telerehabilitation is a promising option for maintaining daily visual tasks. ^{1 3 6 7 8}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7043933/

Telerehabilitation for people with low vision - PMC The goal of low‐vision rehabilitation services, whether in person or remotely via telemedicine, is to help people with vision loss maintain visual functioning ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9837841/

Telerehabilitation for people with low vision - PMC The goal of low vision rehabilitation services, whether in person or remotely via telemedicine, is to help people with vision loss maintain visual functioning ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/12/8/e059985

Scoping review of remote rehabilitation (telerehabilitation) ... This review aims to describe the type of telerehabilitation services available to people with vision impairment and summarise evidence on health-related ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011019.pub4/full

Telerehabilitation for people with low vision - Bittner, AK The included trial found similar efficacy between telerehabilitation with a therapist and an active control intervention of self‐guided training.

5. aao.org aao.org/eyenet/academy-live/detail/telerehabilitation-effect-in-low-vision-patients

Telerehabilitation Found Effective in Improving Reading ... Telerehabilitation with prescribed magnifiers can enhance reading ability and efficiency as an alternative option to in-office vision rehabilitation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9345072/

Scoping review of remote rehabilitation (telerehabilitation ... This review aims to describe the type of telerehabilitation services available to people with vision impairment and summarise evidence on health-related ...

7. tvst.arvojournals.org tvst.arvojournals.org/article.aspx?articleid=2793280

Outcomes of Telerehabilitation Versus In-Office Training With ... Telerehabilitation using videoconferencing to remotely evaluate and provide visual aid training to patients with low vision at home is feasible1,2 and can ...

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00534-0/fulltext

A telerehabilitation program to improve visual perception in ... Safety was evaluated using validated cybersickness questionnaires. Comprehensive vision assessments following standardized low-vision evaluation procedures were ...