NCT06107881

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Dec 2023Jun 2028

First Submitted

Initial submission to the registry

October 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

October 18, 2023

Last Update Submit

September 18, 2025

Conditions

Low VisionLow Vision Aids

Outcome Measures

Primary Outcomes (1)

  • Activity Inventory

    questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

    changes from 1 month to 4 months to 8 months to 12 months to 13 months after receiving a magnification device

Secondary Outcomes (7)

  • MNread

    baseline, 1 month, 4 months, 8 months, 12 months, 13 months

  • Sustained Silent Reading Test

    baseline, 1 month, 4 months, 8 months, 12 months, 13 months

  • International Reading Speed Text (IReST)

    baseline, 1 month, 4 months, 8 months, 12 months, 13 months

  • Radner Reading Charts

    baseline, 1 month, 4 months, 8 months, 12 months, 13 months

  • Vision rehabilitation satisfaction survey

    after each session that will occur over a period of 1 to 8 months and and again at about 1 year

  • +2 more secondary outcomes

Study Arms (2)

Telerehabilitation with low vision provider

EXPERIMENTAL

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

Behavioral: Low Vision Rehabilitation

Usual Care In-Office

ACTIVE COMPARATOR

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

Behavioral: Low Vision Rehabilitation

Interventions

Low Vision RehabilitationBEHAVIORAL

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

Telerehabilitation with low vision providerUsual Care In-Office

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You 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 may not qualify 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Southern Califonia College of Optometry

Fullerton, California, 92831, United States

NOT YET RECRUITING

Chan Family Optometry

Grass Valley, California, 95945, United States

NOT YET RECRUITING

UCLA Stein Eye Institute

Los Angeles, California, 90095, United States

RECRUITING

Frank Stein & Paul S. May Center for Low Vision Rehabilitation at The Eye Institute

San Francisco, California, 94102, United States

NOT YET RECRUITING

See What You Miss Optometry

Santa Monica, California, 90401, United States

NOT YET RECRUITING

New England College of Optometry

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Boston University Eye Associates, Inc.

Brockton, Massachusetts, 02301, United States

NOT YET RECRUITING

Mid-Michigan Eye Care

Midland, Michigan, 48640, United States

NOT YET RECRUITING

University of Nebraska: Weigel Williamson Center for Visual Rehabilitation at the Truhlsen Eye Institute

Omaha, Nebraska, 68198, United States

NOT YET RECRUITING

Related Publications (8)

  • 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.

    PMID: 36951854BACKGROUND

  • 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.

    PMID: 36637057BACKGROUND

  • 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.

    PMID: 36067410BACKGROUND

  • 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.

    PMID: 35917136BACKGROUND

  • Malkin AG, Ross NC, Chun MW, Bittner AK; CARE Study Team. Why Are Visual Assistive Mobile Applications Underused by Low Vision Patients? Optom Vis Sci. 2022 Apr 1;99(4):333-334. doi: 10.1097/OPX.0000000000001893. No abstract available.

    PMID: 35213868BACKGROUND

  • 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.

    PMID: 34770374BACKGROUND

  • 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.

    PMID: 30169361BACKGROUND

  • 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.

    PMID: 30169359BACKGROUND

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ava K Bittner, OD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

UCLA Study Coordinator

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled non-inferiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 30, 2023

Study Start

December 15, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

US(9)