An interventional study of Low Vision Rehabilitation in Low Vision, sponsored by University of California, Los Angeles. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.
This study's enrollment of 61 is close to the median of 60 across 78 interventional studies indexed under Vision, Low.
Browse Vision, Low studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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Exclusion Criteria:
Behavioral: Low Vision Rehabilitation
Behavioral: Low Vision Rehabilitation
Behavioral: Low Vision Rehabilitation
Low Vision Rehabilitation for use of magnification devices for near reading tasks
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
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
Geriatric Depression Scale (GDS)
change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
Time frame: 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
Time frame: 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.
Time frame: between 1 month and 4 months
The recruitment period occurred from October 10, 2019 through December 14, 2022 at academic medical or optometric clinical centers or private optometric practices.
| Milestone | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) |
|---|---|---|
| Started | 38 | 23 |
| Completed | 29 | 18 |
| Not completed | 9 | 5 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: No longer eligible or technical issue with intervention or data | 4 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
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.
| logit | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) |
|---|---|---|
| Activity Inventory | 0.44 (0.08 to 0.80) | 0.43 (0.15 to 0.71) |
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)
| acuity (logMAR) | Telerehabilitation With Low Vision Provider |
|---|---|
| MNread Test of Reading Acuity | 0.08 (0.001 to 0.16) |
change in questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression
| points | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) |
|---|---|---|
| Geriatric Depression Scale (GDS) | -0.14 (-1.18 to 0.89) | 1.11 (-0.29 to 2.52) |
change in questionnaire; subscales range from 0 to 21 for both anxiety and depression with higher values indicating greater depression or anxiety
| points | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) |
|---|---|---|
| Depression | -0.29 (-1.16 to 0.59) | 0.22 (-1.04 to 1.48) |
| Anxiety | -0.50 (-1.42 to 0.42) | 0.72 (-0.63 to 1.74) |
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.
| log reading speed (log words per minute) | Telerehabilitation With Low Vision Provider |
|---|---|
| MNread Test of Reading Speed | 0.18 (0.06 to 0.29) |
Collected over from enrollment (baseline) until end of follow-up at ~4-months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telerehabilitation With Low Vision Provider | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Usual Care (Active Control) | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
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).
| Age, Continuous(years) | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) | Total |
|---|---|---|---|
| Median | 70 (20 to 93) | 72 (25 to 91) | 71 (20 to 93) |
| Sex: Female, Male(Participants) | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) | Total |
|---|---|---|---|
| Female | 20 | 11 | 31 |
| Male | 9 | 7 | 16 |
| Race (NIH/OMB)(Participants) | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 6 |
| White | 23 | 14 | 37 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Activity Inventory: Reading Ability(logits) | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) | Total |
|---|---|---|---|
| Mean | -0.61 ± 0.88 | -0.54 ± 0.75 | -0.58 ± 0.82 |
| logMAR distance best-corrected visual acuity(logMAR units) | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) | Total |
|---|---|---|---|
| Median | 0.50 (0.18 to 1.5) | 0.42 (0.06 to 1.0) | 0.48 (0.06 to 1.5) |
| Newly Prescribed Magnifier Type(Participants) | Telerehabilitation With Low Vision Provider | Usual Care (Active Control) | Total |
|---|---|---|---|
| hand-held optical LED magnifiers | 20 | 13 | 33 |
| stand optical LED magnifier | 3 | 3 | 6 |
| Portable electronic magnifier | 6 | 2 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2019 to primary completion in Nov 2023, 49 months.
Results were first posted in Jun 2025, 1 year 7 months after primary completion.
Of 38 interventional studies with no phase under Vision, Low, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's 49 months is above that.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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