Beacon Sensors and Telerehabilitation for Low Vision

NCT04066075 | Completed Results

• 1 other identifier: #19-000267 and #18-002041
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

Brief Summary

The successful application of magnification devices for reading and daily tasks is predicated on their correct use by individuals with low vision (LV). Barriers related to transportation, geography, and/or co-morbidities often limit LV patients' ability to attend several in-office training sessions as part of low vision rehabilitation (LVR) to optimize visual function with magnification devices. A promising solution is real-time videoconferencing to provide telerehabilitation, involving remotely delivered LVR services by a LVR provider in office to a patient at home. Telerehabilitation for LV appears to be feasible and acceptable by both patients and LVR providers, yet there are no published outcomes on the potential to improve patients' visual functioning. Another key issue in LVR is the need for an effective system to continually assess how patients are functioning at home. Ideally this would involve a non-invasive, efficient method to assess when magnifier device abandonment occurs, so that a timely telerehabilitation session can be initiated. Small Bluetooth low energy beacon sensors attached to the handles of magnifiers can collect real-time data regarding minute-to-minute environmental changes, which might serve as an indicator of magnifier use by LV patients at home. Specifically, the investigators propose to assess the potential for telerehabilitation to enhance visual function by providing remotely-delivered LVR training to use magnification devices. Following one in-office training session for new magnification device(s), the investigators aim to determine if there is additional gain in visual functioning by randomizing subjects to telerehabilitation or additional in-office LVR (active control). Participants will be assessed before and after two consecutive periods: (1) one month after a single LVR training session, followed by (2) up to three LVR sessions over a three month period either via telerehabilitation in the participants' homes or LVR in-office. The investigators will determine which patient characteristics and/or magnification devices are most likely to benefit from telerehabilitation. The investigators will also determine whether data from Bluetooth beacon sensors are valid indicators of hand-held magnifier device usage by LV patients at home. The study investigators will deploy Estimote Sticker beacon sensors to subjects randomized to telerehabilitation or additional in-office LVR during the same study period. It is anticipated that beacon sensors will measure significantly increased temperature and/or motion when placed on the part of the magnification device held by LV patients while performing daily activities. Beacon sensor data will determine if it is feasible to assess when magnification devices are used, and if the frequency of magnifier use changes following telerehabilitation or in-office LVR. This work will evaluate and refine the procedures for implementing these technologies for LVR, in order to develop future randomized controlled trial protocols. The investigators envision that telerehabilitation and beacon sensors could improve LV patient outcomes by providing follow-up LVR services in a more efficient and timely manner.

Conditions

Low Vision

Outcome Measures

Primary Outcomes (1)

• Activity Inventory

  change in the 'Activity Inventory' questionnaire; scores for reading ability were Rasch analyzed in logit units with higher or positive scores indicating less difficulty (i.e., improvement)(Higher values represent a better outcome/ability). Range of changes from 1 month to 4 months after receiving a magnification device were -2.06 to 2.59.

  change from 1 month to 4 months after receiving a magnification device

Secondary Outcomes (4)

• MNread Test of Reading Acuity

  between 1 month and 4 months

• Geriatric Depression Scale (GDS)

  baseline, 4 months

• Hospital Anxiety & Depression Scale

  baseline, 4 months

• MNread Test of Reading Speed

  between 1 month and 4 months

Study Arms (3)

Telerehabilitation with low vision provider

EXPERIMENTAL

Behavioral: Low Vision Rehabilitation

Telerehabilitation w/ low vision provider plus tele-extender

EXPERIMENTAL

Behavioral: Low Vision Rehabilitation

Usual Care (active control)

ACTIVE COMPARATOR

Behavioral: Low Vision Rehabilitation

Interventions

Low Vision Rehabilitation BEHAVIORAL

Low Vision Rehabilitation for use of magnification devices for near reading tasks

Telerehabilitation w/ low vision provider plus tele-extender; Telerehabilitation with low vision provider; Usual Care (active control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any level of vision loss due to any ocular disease who are age 18 and older, and who have received new magnification device(s) for the first time (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and CCTVs) from one of our participating sites.

You may not qualify if:

• schedules not permitting participation in planned study visits (including planning to move or take extended vacation during study period),
• inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment as per TICS),
• substance abuse,
• significant hearing loss (unable to hear communication by phone or via videoconferencing),
• significant medical condition likely to limit participation or lifespan, individuals who require other types of LVR training or intervention (e.g., technology/computer skills, psychosocial),
• magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), and/or (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Eye Institute (NEI): collaborator
• American Academy of Optometry: collaborator
• Southern California College of Optometry at Marshall B. Ketchum University: collaborator
• New England College of Optometry: collaborator
• University of Nebraska: collaborator
• Mid Michigan Health Centers: collaborator
• Eye Vision Associates: collaborator
• See What You Miss Optometry: collaborator
• Low Vision Services, PLC: collaborator
• Pacific Vision Foundation: collaborator
• Boston University: collaborator

Study Sites (11)

Southern Califonia College of Optometry

Fullerton, California, 92831, United States

Location

Chan Family Optometry

Grass Valley, California, 95945, United States

Location

UCLA Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute

San Francisco, California, 94102, United States

Location

See What You Miss Optometry

Santa Monica, California, 90401, United States

Location

New England College of Optometry

Boston, Massachusetts, 02115, United States

Location

Boston University Eye Associates, Inc.

Brockton, Massachusetts, 02301, United States

Location

Mid-Michigan Eye Care

Midland, Michigan, 48640, United States

Location

University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute

Omaha, Nebraska, 68198, United States

Location

Eye Vision Associates

Nesconset, New York, 11767, United States

Location

Low Vision Services, PLC: Low Vision Learning Center

Alexandria, Virginia, 22314, United States

Location

Related Publications (8)

• Bittner AK, Yoshinaga P, Bowers A, Shepherd JD, Succar T, Ross NC. Feasibility of Telerehabilitation for Low Vision: Satisfaction Ratings by Providers and Patients. Optom Vis Sci. 2018 Sep;95(9):865-872. doi: 10.1097/OPX.0000000000001260.

  PMID: 30169361 BACKGROUND

• Bittner AK, Jacobson AJ, Khan R. Feasibility of Using Bluetooth Low Energy Beacon Sensors to Detect Magnifier Usage by Low Vision Patients. Optom Vis Sci. 2018 Sep;95(9):844-851. doi: 10.1097/OPX.0000000000001266.

  PMID: 30169359 BACKGROUND

• Bittner AK, Yoshinaga PD, Rittiphairoj T, Li T. Telerehabilitation for people with low vision. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD011019. doi: 10.1002/14651858.CD011019.pub4.

  PMID: 36637057 BACKGROUND

• Bittner AK, Yoshinaga PD, Shepherd JD, Kaminski JE, Malkin AG, Chun MW, Chan TL, Deemer AD, Ross NC; BeST-AID Study Team. Acceptability of Telerehabilitation for Magnification Devices for the Visually Impaired Using Various Approaches to Facilitate Accessibility. Transl Vis Sci Technol. 2022 Aug 1;11(8):4. doi: 10.1167/tvst.11.8.4.

  PMID: 35917136 RESULT

• Bittner AK, Estabrook M, Dennis N. Bluetooth Low Energy Beacon Sensors to Document Handheld Magnifier Use at Home by People with Low Vision. Sensors (Basel). 2021 Oct 25;21(21):7065. doi: 10.3390/s21217065.

  PMID: 34770374 RESULT

• Kaminski JE, Yoshinaga PD, Chun MW, Yu M, Shepherd JD, Chan TL, Deemer A, Bittner AK; BeST-AID Study Team. Value of Handheld Optical Illuminated Magnifiers for Sustained Silent Reading by Visually Impaired Adults. Optom Vis Sci. 2023 May 1;100(5):312-318. doi: 10.1097/OPX.0000000000002013. Epub 2023 Mar 22.

  PMID: 36951854 RESULT

• Bittner AK, Kaminski JE, Ross NC, Shepherd JD, Thoene SJ, Bui SZ, Yoshinaga PD; BeST-AID Study Team. Telerehabilitation Training to Facilitate Improved Reading Ability with New Magnification Devices for Low Vision. Optom Vis Sci. 2022 Oct 1;99(10):743-749. doi: 10.1097/OPX.0000000000001944. Epub 2022 Sep 6.

  PMID: 36067410 RESULT

• Bittner AK, Kaminski JE, Yoshinaga PD, Shepherd JD, Chan TL, Malkin AG, Deemer A, Gobeille M, Thoene SJ, Rossi A, Ross NC; BeST-AID Study Team. Outcomes of Telerehabilitation Versus In-Office Training With Magnification Devices for Low Vision: A Randomized Controlled Trial. Transl Vis Sci Technol. 2024 Jan 2;13(1):6. doi: 10.1167/tvst.13.1.6.

  PMID: 38214688 RESULT

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ava K. Bittner, OD, PhD
• Organization: University of California Los Angeles

researchatvrc@gmail.com

310-206-9566

Study Officials

• Ava K Bittner, OD, PhD

  UCLA Stein Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: October 10, 2019
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Locations

US (11)