Design and Clinical Evaluation of a Smartphone-based Low Vision Enhancement System

NCT03728660 | Completed

• 2 other identifiers: IRB000863664R44EY028077-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to compare the effectiveness and adverse side-effects of the virtual bioptic telescope and virtual projection screen in a new head-mounted video-based low vision enhancement system (LVES) with a wide field of view to currently employed specifications for head-mounted video display low vision enhancement technology. Secondary objectives are to acquire qualitative information from patients to evaluate the functioning of the system, to optimize system features and operations, and to assess the value patients place on system features, functions, and operating parameters relative to those of current technology. Investigators will conduct a comparative effectiveness study to determine if the novel vision enhancing features of LVES 2 provide low vision patients with benefits superior to those provided by existing technology.

Conditions

Low Vision

Keywords

age related macular degeneration; visual impairment; virtual reality

Outcome Measures

Primary Outcomes (1)

• Mean change in patients' self-reported functional ability as assessed by the Activity Inventory (AI) rating scale questionnaire

  Functional ability is estimated from difficulty ratings of items in the AI, a questionnaire that banks 510 items describing common activities. 50 items are "goals", broad descriptions of activity accomplishments. The other 460 items are "tasks", specific activities typically performed to achieve goals. The patient rates the importance of each goal. Unimportant goals are skipped, otherwise the patient rates the goal's difficulty. If "not difficult", the patient skips to the next goal, otherwise rates the difficulty of the goal's subsidiary tasks, or responds "not applicable". The average ability required by each item and the functional ability of each patient are estimated on the same scale with Rasch analysis. The 510 item measures in the AI are fixed to values for 3000 low vision patients. The investigators will analyze functional ability change score distributions for the two interventions before and after the crossover.

  2 weeks, 24 weeks

Secondary Outcomes (1)

• Minimum Clinically Important Difference (MCID) in patient's self-reported functional ability estimated from difficulty ratings of activities in the AI rating scale questionnaire

  2 weeks, 24 weeks

Study Arms (2)

LVES 2 first LEGACY second

EXPERIMENTAL

Virtual bioptic magnification with large field of view (LVES 2) followed by 22-week washout period and then Full field magnification with small field of view (LEGACY)

Device: Virtual bioptic magnification with large field of view; Device: Full field magnification with small field of view

LEGACY first LVES 2 second

ACTIVE COMPARATOR

Full field magnification with small field of view (LEGACY) followed by 22-week washout period and then Virtual bioptic magnification with large field of view (LVES 2)

Device: Virtual bioptic magnification with large field of view; Device: Full field magnification with small field of view

Interventions

Virtual bioptic magnification with large field of view DEVICE

The intervention device will have a larger field of vision than the legacy device and the intervention device will also have a virtual bioptic telescope mode not found on the legacy device. The user will be able to adjust the size of the virtual bioptic telescope and the amount of magnification with a touch pad on the side of the head-mounted display (HMD).

Also known as: LVES 2, IrisVision

LEGACY first LVES 2 second; LVES 2 first LEGACY second

Full field magnification with small field of view DEVICE

Comparison intervention with user-controlled full field magnification with a smaller field size shared by legacy head-mounted devices. User can control amount of magnification

Also known as: LEGACY

LEGACY first LVES 2 second; LVES 2 first LEGACY second

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Visual acuity in the better-seeing eye 20/60-20/800
• Horizontal visual field extent \>70 degrees diameter, vertical visual field extent \>50 degrees.
• Indicate at least 2 goals from the Activity Inventory during the initial screening interview.
• Scores at least 27 in the Telephone Interview Cognitive Status during the initial screening interview

You may not qualify if:

• Patients who are planning ocular surgery (including laser surgery) during the period of study participation or are early in anti-neovascular treatment (\<6 injections)
• Younger than 14 years of age
• Unable to participate in a telephone interview
• Indicate less than 2 goals from the Activity Inventory
• Score less than 27 in the Telephone Interview Cognitive Status

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Eye Institute (NEI): collaborator
• Visionize, LLC: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Deemer AD, Bradley CK, Ross NC, Natale DM, Itthipanichpong R, Werblin FS, Massof RW. Low Vision Enhancement with Head-mounted Video Display Systems: Are We There Yet? Optom Vis Sci. 2018 Sep;95(9):694-703. doi: 10.1097/OPX.0000000000001278.

  PMID: 30153240 BACKGROUND

• Goldstein JE, Jackson ML, Fox SM, Deremeik JT, Massof RW; Low Vision Research Network Study Group. Clinically Meaningful Rehabilitation Outcomes of Low Vision Patients Served by Outpatient Clinical Centers. JAMA Ophthalmol. 2015 Jul;133(7):762-9. doi: 10.1001/jamaophthalmol.2015.0693.

  PMID: 25856370 BACKGROUND

• Massof RW, Ahmadian L, Grover LL, Deremeik JT, Goldstein JE, Rainey C, Epstein C, Barnett GD. The Activity Inventory: an adaptive visual function questionnaire. Optom Vis Sci. 2007 Aug;84(8):763-74. doi: 10.1097/OPX.0b013e3181339efd.

  PMID: 17700339 BACKGROUND

• Chun R, Deemer A, Fujiwara K, Deremeik J, Bradley CK, Massof RW, Werblin FS. Comparative effectiveness between two types of head-mounted magnification modes using a smartphone-based virtual display. Optom Vis Sci. 2024 Jun 1;101(6):342-350. doi: 10.1097/OPX.0000000000002115. Epub 2024 Apr 12.

  PMID: 38551973 DERIVED

MeSH Terms

Conditions

Vision, Low; Macular Degeneration; Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Officials

• Robert W Massof, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Baseline AI administered prior to randomization, outcomes assessor masked on intervention assignment before and after crossover
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intention to treat design; crossover with 22 week washout period between interventions; primary outcome measure is patient-reported function

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: January 29, 2019
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 16, 2021

Record last verified: 2020-12

Locations

US (1)