Low Vision
Conditions
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.
Interventions
BEHAVIORALLow Vision Rehabilitation
Low Vision Rehabilitation for use of magnification devices for near reading tasks
Sponsors
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
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 1x1 to which the beacon sensor could be attached without interfering with the device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity Inventory | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MNread Test of Reading Acuity | between 1 month and 4 months | 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) |
| Geriatric Depression Scale (GDS) | baseline, 4 months | change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression |
| Hospital Anxiety & Depression Scale | baseline, 4 months | change in questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety |
| MNread Test of Reading Speed | between 1 month and 4 months | 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. |
Countries
United States
Participant flow
Recruitment details
The recruitment period occurred from October 10, 2019 through December 14, 2022 at academic medical or optometric clinical centers or private optometric practices.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 23 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | no longer eligible or technical issue with intervention or data | 4 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Total | Usual Care (Active Control) | Telerehabilitation With Low Vision Provider |
|---|---|---|---|
| Activity Inventory: Reading Ability | -0.58 logits STANDARD_DEVIATION 0.82 | -0.54 logits STANDARD_DEVIATION 0.75 | -0.61 logits STANDARD_DEVIATION 0.88 |
| Age, Continuous | 71 years | 72 years | 70 years |
| logMAR distance best-corrected visual acuity | 0.48 logMAR units | 0.42 logMAR units | 0.50 logMAR units |
| Newly Prescribed Magnifier Type hand-held optical LED magnifiers | 33 Participants | 13 Participants | 20 Participants |
| Newly Prescribed Magnifier Type Portable electronic magnifier | 8 Participants | 2 Participants | 6 Participants |
| Newly Prescribed Magnifier Type stand optical LED magnifier | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Female | 31 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 16 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 18 |
| other Total, other adverse events | 0 / 29 | 0 / 18 |
| serious Total, serious adverse events | 0 / 29 | 0 / 18 |
Outcome results
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.
Time frame: change from 1 month to 4 months after receiving a magnification device
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telerehabilitation With Low Vision Provider | Activity Inventory | 0.44 logit |
| Usual Care (Active Control) | Activity Inventory | 0.43 logit |
Comparison: Multilevel modeling in linear regression analyses accounted for within-patient correlations for the 3 assessments at baseline, 1-month and 4-months. Rasch analysis using the method of successive dichotomizations was applied to estimate person measures. Power calculation: a matched pairs t-test revealed 18 subjects per group would detect a within-subject mean improvement of 0.14-logits with 0.17-logits standard deviation for the differences, 0.80 power and 0.05 type 1 error probability.p-value: 0.73Multilevel linear regression model
Secondary
Geriatric Depression Scale (GDS)
change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
Time frame: baseline, 4 months
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telerehabilitation With Low Vision Provider | Geriatric Depression Scale (GDS) | -0.14 points |
| Usual Care (Active Control) | Geriatric Depression Scale (GDS) | 1.11 points |
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
Time frame: baseline, 4 months
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Telerehabilitation With Low Vision Provider | Hospital Anxiety & Depression Scale | Depression | -0.29 points |
| Telerehabilitation With Low Vision Provider | Hospital Anxiety & Depression Scale | Anxiety | -0.50 points |
| Usual Care (Active Control) | Hospital Anxiety & Depression Scale | Depression | 0.22 points |
| Usual Care (Active Control) | Hospital Anxiety & Depression Scale | Anxiety | 0.72 points |
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)
Time frame: between 1 month and 4 months
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telerehabilitation With Low Vision Provider | MNread Test of Reading Acuity | 0.08 acuity (logMAR) |
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.
Time frame: between 1 month and 4 months
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telerehabilitation With Low Vision Provider | MNread Test of Reading Speed | 0.18 log reading speed (log words per minute) |