Recruiting

Beacon Sensors

Sponsor:

UCLA

Code:

NCT06107881

Conditions

Low Vision

Low Vision Aids

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low Vision Rehabilitation

Study Details

Brief summary:

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.

Conditions

Low Vision

Low Vision Aids

Study ID

NCT06107881

Start date

Dec 15, 2023

Status verified date

Sep, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telerehabilitation with low vision provider

Low Vision Rehabilitation for use of magnification or visual assistive devices using videoconferencing for remotely delivered follow-up care

active comparator: Usual Care In-Office

Low Vision Rehabilitation in-office for use of magnification or visual assistive devices

Interventions

Low Vision Rehabilitation

Evaluation and training with magnification or visual assistive devices for visually-impaired adults

Primary outcome measure

  • Activity Inventory [ Time Frame: changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device ]

Central Contacts and Locations

Central contacts

UCLA Study Coordinator

310-794-5602JessicaSLin@mednet.ucla.edu

Locations

UCLA Stein Eye Institute

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ava K Bittner, OD, PhD

310-206-4649

Principal Investigator:

Ava K Bittner, OD, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-09-23.