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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| American Academy of Optometry | OTHER |
| Southern California College of Optometry at Marshall B. Ketchum University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation with low vision provider | Experimental |
| |
| Telerehabilitation w/ low vision provider plus tele-extender | Experimental |
| |
| Usual Care (active control) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Vision Rehabilitation | Behavioral | Low Vision Rehabilitation for use of magnification devices for near reading tasks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | between 1 month and 4 months |
| Geriatric Depression Scale (GDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ava K Bittner, OD, PhD | UCLA Stein Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Califonia College of Optometry | Fullerton | California | 92831 | United States | ||
| Chan Family Optometry |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30169361 | Background | 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. | |
| 30169359 | 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. |
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Enrolled participants were excluded from the study before randomization assignment to arms or groups if they did not complete the baseline study assessments by phone.
The recruitment period occurred from October 10, 2019 through December 14, 2022 at academic medical or optometric clinical centers or private optometric practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telerehabilitation With Low Vision Provider | Remote training for newly prescribed magnification devices via Zoom videoconferencing with the vision rehabilitation provider in-office and the participant at home. The training for magnifiers was individualized based on participants' needs, by providing verbal instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. |
| FG001 | Usual Care (Active Control) | Training provided in-office or clinical settings in-person for the use of newly prescribed magnification devices that was individualized based on participants' needs. The training for magnifiers involves instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3).
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| ID | Title | Description |
|---|---|---|
| BG000 | Telerehabilitation With Low Vision Provider | Remote training for newly prescribed magnification devices via Zoom videoconferencing with the vision rehabilitation provider in-office and the participant at home. The training for magnifiers was individualized based on participants' needs, by providing verbal instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Posted | Mean | 95% Confidence Interval | logit | change from 1 month to 4 months after receiving a magnification device |
|
from enrollment (baseline) until end of follow-up at ~4-months
Adverse events were all self-reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telerehabilitation With Low Vision Provider | Remote training for newly prescribed magnification devices via Zoom videoconferencing with the vision rehabilitation provider in-office and the participant at home. The training for magnifiers was individualized based on participants' needs, by providing verbal instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ava K. Bittner, OD, PhD | University of California Los Angeles | 310-206-9566 | researchatvrc@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 | Apr 29, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2022 | Apr 2, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| New England College of Optometry |
| OTHER |
| University of Nebraska | OTHER |
| Mid Michigan Health Centers | OTHER |
| Eye Vision Associates | UNKNOWN |
| See What You Miss Optometry | UNKNOWN |
| Low Vision Services, PLC | UNKNOWN |
| Pacific Vision Foundation | OTHER |
| Boston University | OTHER |
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change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression |
| 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 | 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. | between 1 month and 4 months |
| Grass Valley |
| California |
| 95945 |
| United States |
| UCLA Stein Eye Institute | Los Angeles | California | 90095 | United States |
| Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute | San Francisco | California | 94102 | United States |
| See What You Miss Optometry | Santa Monica | California | 90401 | United States |
| New England College of Optometry | Boston | Massachusetts | 02115 | United States |
| Boston University Eye Associates, Inc. | Brockton | Massachusetts | 02301 | United States |
| Mid-Michigan Eye Care | Midland | Michigan | 48640 | United States |
| University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute | Omaha | Nebraska | 68198 | United States |
| Eye Vision Associates | Nesconset | New York | 11767 | United States |
| Low Vision Services, PLC: Low Vision Learning Center | Alexandria | Virginia | 22314 | United States |
| 36637057 | 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. |
| 35917136 | Result | 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. |
| 34770374 | 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. |
| 36951854 | 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. |
| 36067410 | 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. |
| 38214688 | 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. |
| Withdrawal by Subject |
|
| BG001 | Usual Care (Active Control) | Training provided in-office or clinical settings in-person for the use of newly prescribed magnification devices that was individualized based on participants' needs. The training for magnifiers involves instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Count of Participants | Participants | No |
|
| Activity Inventory: Reading Ability | The 'Activity Inventory' is a questionnaire or patient reported outcome measure to assess reading ability during activities of daily living. Higher values represent better reading ability. Baseline scores ranged from -2.95 to 0.62. | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Mean | Standard Deviation | logits |
|
| logMAR distance best-corrected visual acuity | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Median | Full Range | logMAR units |
|
| Newly Prescribed Magnifier Type | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Count of Participants | Participants | No |
|
Remote training for newly prescribed magnification devices via Zoom videoconferencing with the vision rehabilitation provider in-office and the participant at home. The training for magnifiers was individualized based on participants' needs, by providing verbal instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near.
| OG001 | Usual Care (Active Control) | Training provided in-office or clinical settings in-person for the use of newly prescribed magnification devices that was individualized based on participants' needs. The training for magnifiers involves instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. |
|
|
|
| Secondary | 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) | Participants were not included in the analysis if they were in the usual care group, had 2 telerehabilitation sessions at which the MNRead test was administered, if they were lost to follow-up (n=6), discontinued telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Posted | Mean | 95% Confidence Interval | acuity (logMAR) | between 1 month and 4 months |
|
|
|
| Secondary | Geriatric Depression Scale (GDS) | change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Posted | Mean | 95% Confidence Interval | points | baseline, 4 months |
|
|
|
| Secondary | 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 | Participants were not included in the analysis if they were lost to follow-up (n=6), discontinued the telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Posted | Mean | 95% Confidence Interval | points | baseline, 4 months |
|
|
|
| Secondary | 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. | Participants were not included in the analysis if they were in the usual care group, had 2 telerehabilitation sessions at which the MNRead test was administered, if they were lost to follow-up (n=6), discontinued telerehabilitation intervention due to technical issues (n=1), discontinued the trial since they were too busy (n=3) or no longer interested (n=1), became no longer eligible per inclusion/exclusion criteria (n=2), or did not have completed study assessment at 1-month or 4-months (n=3). | Posted | Mean | 95% Confidence Interval | log reading speed (log words per minute) | between 1 month and 4 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Usual Care (Active Control) | Training provided in-office or clinical settings in-person for the use of newly prescribed magnification devices that was individualized based on participants' needs. The training for magnifiers involves instructions to adjust placement of the reading material and/or magnifier, including feedback on working distance, viewing angle, movement and/or obtaining appropriate magnification levels and field of view while reading at near. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Portable electronic magnifier |
|