Low VisionBeST-AIDNCT04066075
Beacon Sensors and Telerehabilitation for Low Vision
A study testing Low Vision Rehabilitation in people with Low Vision, run by University of California, Los Angeles at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Vision
- What is being tested?
- Low Vision Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 11 sitesUnited States
- Study dates
- 10 Oct 2019to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Low Vision Services, PLC: Low Vision Learning Center
Alexandria, Virginia, 22314
New England College of Optometry
Boston, Massachusetts, 02115
Boston University Eye Associates, Inc.
Brockton, Massachusetts, 02301
Southern Califonia College of Optometry
Fullerton, California, 92831
Chan Family Optometry
Grass Valley, California, 95945
UCLA Stein Eye Institute
Los Angeles, California, 90095
Mid-Michigan Eye Care
Midland, Michigan, 48640
Eye Vision Associates
Nesconset, New York, 11767
University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
Omaha, Nebraska, 68198
Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
San Francisco, California, 94102
See What You Miss Optometry
Santa Monica, California, 90401
About this study
Official title: Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning
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
- Being tested
- Low Vision Rehabilitation
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Vision RehabilitationBehavioural
Low Vision Rehabilitation for use of magnification devices for near reading tasks
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation with low vision provider | Experimental | Not described Receives: Behavioral: Low Vision Rehabilitation |
| Telerehabilitation w/ low vision provider plus tele-extender | Experimental | Not described Receives: Behavioral: Low Vision Rehabilitation |
| Usual Care (active control) | Active comparator | Not described Receives: Behavioral: Low Vision Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from 1 month to 4 months after receiving a magnification device
Secondary outcomes (4)
MNread Test of Reading Acuity
change in reading test measured during the telerehabilitation sessions for participants who completed the MNread at two telerehabilitation sessions to indicate their reading acuity (smallest size read in logMAR units)
Measured: between 1 month and 4 months
Geriatric Depression Scale (GDS)
change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
Measured: baseline, 4 months
Hospital Anxiety & Depression Scale
change in questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety
Measured: baseline, 4 months
MNread Test of Reading Speed
change in reading test measured during the telerehabilitation sessions for participants who completed the MNread at two telerehabilitation sessions to indicate their log reading speed measured as words per minute.
Measured: between 1 month and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start10 Oct 2019
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), American Academy of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, New England College of Optometry, University of Nebraska, Mid Michigan Health Centers, Eye Vision Associates, See What You Miss Optometry, Low Vision Services, PLC, Pacific Vision Foundation, Boston University
- Responsible party
- Principal investigator, Ava K. Bittner, OD, PhD, University of California, Los Angeles
- Investigators
- Ava K Bittner, OD, PhD, Principal investigator, UCLA Stein Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066075
- Sponsor's protocol ID
- #19-000267 and #18-002041
- Acronym
- BeST-AID
- Status last verified
- Jun 2025
- First submitted
- 19 Aug 2019
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30169361Bittner 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.
PubMed 30169359Bittner 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.
PubMed 36637057Bittner 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.
PubMed 35917136Bittner 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.
PubMed 34770374Kaminski 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.
PubMed 36951854Bittner 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.
PubMed 36067410Bittner 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.
PubMed 38214688
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beacon Sensors & Telerehabilitation to Assess & Improve Use of Devices for Visual Functioning
- ClinicalTrials.gov ID
- NCT04066075
- Acronym / sponsor ID
- BeST-AID / #19-000267 and #18-002041
- Conditions
- Low Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), American Academy of Optometry, Southern California College of Optometry at Marshall B. Ketchum University, New England College of Optometry, University of Nebraska, Mid Michigan Health Centers, Eye Vision Associates, See What You Miss Optometry, Low Vision Services, PLC, Pacific Vision Foundation, Boston University
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Posted 29 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Vision RehabilitationLow Vision Rehabilitation for use of magnification devices for near reading tasks | Behavioural | Telerehabilitation w/ low vision provider plus tele-extender, Telerehabilitation with low vision provider, Usual Care (active control) |
Primary outcome
Activity Inventory
Time frame: change from 1 month to 4 months after receiving a magnification device
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.
4 secondary outcomes
MNread Test of Reading Acuity
Time frame: between 1 month and 4 months
Geriatric Depression Scale (GDS)
Time frame: baseline, 4 months
Hospital Anxiety & Depression Scale
Time frame: baseline, 4 months
MNread Test of Reading Speed
Time frame: between 1 month and 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30169361Bittner 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.
- Background: PubMed 30169359Bittner 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.
- Background: PubMed 36637057Bittner 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.
- Results publication: PubMed 35917136Bittner 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.
- Results publication: PubMed 34770374Bittner 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.
- Results publication: PubMed 36951854Kaminski 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.
- Results publication: PubMed 36067410Bittner 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.
- Results publication: PubMed 38214688Bittner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ava K Bittner, OD, PhD principal investigator
UCLA Stein Eye Institute
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Vision Rehabilitation in people with Low Vision, run by University of California, Los Angeles at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Inventory (time frame: change from 1 month to 4 months after receiving a magnification device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066075, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.