What this study is
One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services.
What's being tested
- Low Vision Rehabilitation
Intervention · BEHAVIORAL
Evaluation and training with magnification or visual assistive devices for visually-impaired adults
Study details
- Sponsor
- University of California, Los Angeles
- Conditions
- Low Vision · Low Vision Aids
- Enrolling
- 350 people
- Starts
- 2023-12-15
- Est. completion
- 2028-06-30
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults with 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, high near add powers of +4.00 or greater, visual assistive mobile apps for their smartphone/tablet, some stand magnifiers and CCTVs) from one of our participating low vision rehabilitation sites at the four academic centers and one private practice.
You can't join if
- Schedules not permitting participation in planned study visits (including planning to move far from their clinical provider's office within the first 4-months of the study (i.e., cannot attend in-office visits) or take extended vacation that would not allow them to complete study procedures during the first four months of the study period),
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (greater than mild 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., psychosocial).
- For Bluetooth low energy beacon sensors, exclusion would occur if their 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), (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openSouthern Califonia College of Optometry
Fullerton, California, United States
- Patrick Yoshinaga, OD · Contact
Not yet recruitingChan Family Optometry
Grass Valley, California, United States
- Tiffany L Chan, OD · Contact
Not yet recruitingUCLA Stein Eye Institute
Los Angeles, California, United States
- Ava K Bittner, OD, PhD · Contact310-206-4649
- Ava K Bittner, OD, PhD · Principal investigator
RecruitingFrank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute
San Francisco, California, United States
- Tiffany Chan, OD · Contact
Not yet recruitingSee What You Miss Optometry
Santa Monica, California, United States
- Lynn Watt Kurata, OD · Contact
Not yet recruitingNew England College of Optometry
Boston, Massachusetts, United States
- Nicole C Ross, OD · Contact
Not yet recruitingBoston University Eye Associates, Inc.
Brockton, Massachusetts, United States
- Lexi G Malkin, OD · Contact
Not yet recruitingMid-Michigan Eye Care
Midland, Michigan, United States
- John E Kaminski, OD · Contact
Not yet recruitingUniversity of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute
Omaha, Nebraska, United States
- John Shepherd, MD · Contact
Not yet recruiting
Study team
Sponsor
University of California, Los Angeles
Study ID BeST-AID 2.0
Principal investigator
Ava K Bittner, OD, PhD
University of California, Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.