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Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision

Primary Purpose

Low Vision Blindness, Visual Impairment, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visual Information Training
Multimodal training
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Vision Blindness focused on measuring ultra low vision rehabilitation, multi sensory, functional vision assessment

Eligibility Criteria

12 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • People with ultra low vision (visual acuity ≤20/1600)

Exclusion Criteria:

  • <12 years of age
  • dependent on sighted guide
  • cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Visual Information Training

    Multimodal Training

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in visual ability
    Change in visual ability as measured by the Ultra Low Vision Visual Function Questionnaire. The scale measures both visual ability (Person Measure) and difficulty (Item Measure) in people with ultra low vision. 150 items on a likert scale ranging from 1 impossible, to 4 not difficult. Using a Rasch-Andrich rating model, Person Measures range from -6 to +2.8 logits, Item Measures range from -3.3 to +3.0 logits. Higher scores indicating better outcome.

    Secondary Outcome Measures

    Change in hand-eye coordination
    Change in hand eye coordination as assessed by a leap motion (Ultra Leap) sensor taped to a Virtual Reality headset to track hand eye coordination.
    Change in hearing ability
    Change in hearing ability as assessed by iHEARtest device (earphones, computer application). The participant presses the space bar on their computer keyboard every time they hear a sound. The iHEARtest provides a Hearing Number™ in each ear on a scale from 1=profound impairment, to 5= no impairment.

    Full Information

    First Posted
    August 25, 2021
    Last Updated
    August 7, 2023
    Sponsor
    Johns Hopkins University
    Collaborators
    State University of New York College of Optometry
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05028712
    Brief Title
    Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
    Official Title
    Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    July 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    State University of New York College of Optometry

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Vision Blindness, Visual Impairment, Quality of Life, Functional Visual Loss
    Keywords
    ultra low vision rehabilitation, multi sensory, functional vision assessment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Visual Information Training
    Arm Type
    Experimental
    Arm Title
    Multimodal Training
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Visual Information Training
    Intervention Description
    Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multimodal training
    Intervention Description
    Participants in this arm will receive training in integrating input from different senses to enhance functional performance.
    Primary Outcome Measure Information:
    Title
    Change in visual ability
    Description
    Change in visual ability as measured by the Ultra Low Vision Visual Function Questionnaire. The scale measures both visual ability (Person Measure) and difficulty (Item Measure) in people with ultra low vision. 150 items on a likert scale ranging from 1 impossible, to 4 not difficult. Using a Rasch-Andrich rating model, Person Measures range from -6 to +2.8 logits, Item Measures range from -3.3 to +3.0 logits. Higher scores indicating better outcome.
    Time Frame
    Baseline, 1 month, 3 months, 6 months
    Secondary Outcome Measure Information:
    Title
    Change in hand-eye coordination
    Description
    Change in hand eye coordination as assessed by a leap motion (Ultra Leap) sensor taped to a Virtual Reality headset to track hand eye coordination.
    Time Frame
    Baseline, 1 month, 3 months, 6 months
    Title
    Change in hearing ability
    Description
    Change in hearing ability as assessed by iHEARtest device (earphones, computer application). The participant presses the space bar on their computer keyboard every time they hear a sound. The iHEARtest provides a Hearing Number™ in each ear on a scale from 1=profound impairment, to 5= no impairment.
    Time Frame
    Baseline, 1 month, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: People with ultra low vision (visual acuity ≤20/1600) Exclusion Criteria: <12 years of age dependent on sighted guide cognitive impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arathy Kartha, PhD
    Phone
    4243981727
    Email
    akartha@sunyopt.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gislin Dagnelie, PhD
    Phone
    4103021792
    Email
    gislin@lions.med.jhu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arathy Kartha, PhD
    Organizational Affiliation
    State University of New York College of Optometry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision

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