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Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus

Primary Purpose

Central Visual Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training of perception and oculo-motor control
Sponsored by
Russell L. Woods
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Visual Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Central Vision Loss Group Inclusion Criteria: Bilateral foveal loss that includes the fovea in each eye, as determined through retinal examination fluent in English Cognitive function MoCA (Montreal Cognitive Assessment) test >20 Binocular visual acuity 20/800 or better able to sit for at least an hour Exclusion Criteria: speech impediment history of neurological or psychiatric disease inability to provide informed consent inability to follow instructions in English Normal Vision Control Group Inclusion Criteria: fluent in English Cognitive function MoCA (Montreal Cognitive Assessment) test >25 Binocular visual acuity 20/40 or better able to sit for at least an hour Exclusion Criteria: any ophthalmic disease that might impact on the conduct of the study, especially conditions that cause vision field loss speech impediment history of neurological or psychiatric disease inability to provide informed consent inability to follow instructions in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    central vision loss

    normal vision

    Arm Description

    will receive behavioral intervention

    using simulated central scotomas, will receive behavioral intervention

    Outcomes

    Primary Outcome Measures

    reading speed following eight training sessions
    reading of paragraphs of text
    reading speed following sixteen training sessions
    reading of paragraphs of text
    face discrimination threshold following eight training sessions
    recognizing differences between faces
    face discrimination threshold following sixteen training sessions
    recognizing differences between faces
    video comprehension (shared word score) following eight training sessions
    understanding and describing the content of short video clips
    video comprehension (shared word score) following sixteen training sessions
    understanding and describing the content of short video clips

    Secondary Outcome Measures

    PRL location relative to the location before the intervention (training)
    location of the preferred retinal locus measured from a retinal image obtained during a fixation examination
    Oculo-motor reference location relative to the location before the intervention (training)
    first landing location of saccades to a new location measured using a gaze tracking system; measures whether there has been an adjustment of eye movement planning
    saccade dynamics relative to the location before the intervention (training)
    slope of the saccadic main sequence, which is the speed to distance relationship of saccades (fast eye movements), as measured using a gaze tracking system
    single-letter visual acuity following eight training sessions
    ability to read single letters of varying size
    single-letter visual acuity following sixteen training sessions
    ability to read single letters of varying size
    letter contrast sensitivity following eight training sessions
    ability to read "large" letters of low contrast
    letter contrast sensitivity following sixteen training sessions
    ability to read "large" letters of low contrast
    Geriatric Depression Scale (GDS) following eight training sessions
    evaluate depression and aspects of quality of life
    Geriatric Depression Scale (GDS) following sixteen training sessions
    evaluate depression and aspects of quality of life
    Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following eight training sessions
    measure of visual ability and vision-related limitations
    Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following sixteen training sessions
    measure of visual ability and vision-related limitations

    Full Information

    First Posted
    November 4, 2022
    Last Updated
    November 24, 2022
    Sponsor
    Russell L. Woods
    Collaborators
    Research to Prevent Blindness / Lions Club International Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05637385
    Brief Title
    Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus
    Official Title
    Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Russell L. Woods
    Collaborators
    Research to Prevent Blindness / Lions Club International Foundation

    4. Oversight

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

    5. Study Description

    Brief Summary
    When high-detail vision is lost due to a retinal disease such as macular degeneration, people see poorly, and have difficulty with eye movements (oculo-motor control). This preliminary study will investigate a potential behavioral intervention that may improve the ability to perform vision-related daily activities such as reading, recognising faces and watching television. The intervention involves many sessions that will train visual perception and eye movements over a period of a few months. Participants will have either lost central vision in both eyes or have normal vision (control group).
    Detailed Description
    The purpose of the study is evaluate a potential treatment for loss of (foveal) central vision in both eyes which results in the use of a preferred retinal locus (PRL). The treatment is a series of 16 sessions of about one-hour duration that will involve a mixture of oculomotor control (OMC) training, perceptual training, and scotoma awareness. Two groups will receive the training: (1) central vision loss; and (2) normal sight who will use a simulated scotoma (called control group below). A single-site, two-way mixed factor, one within-subject and one between-subject, minimal-risk phase-2 study. Each participant with vision loss or in the control group will attend for three outcome-measurement visits and 16 training visits over a period of about two months (at 2 visits per week). Feasibility metrics will be obtained during recruitment and study conduct. PRL and OMC metrics will be obtained at every visit. Outcome metrics will be obtained before treatment, following 8 training sessions, and following 16 training sessions. Participants in the control group will experience a simulated central scotoma created by a gaze-contingent visual display system that simulates the loss of central vision by obscuring a region of central vision during testing and training. Participants will be trained using an integrated oculo-motor and perceptual training approach using a gaze-contingent visual display to provide scotoma awareness. Two tasks will alternate: (1) a textured search target that suddenly shifts, drifts smoothly, or is stable, requiring the subject to make a saccade, a smooth pursuit, or fixate, respectively, following which there is a same-different task to test attention; and (2) target following and visual search for (a) face within distractors, (b) object recognition and location, and (c) word recognition and object identification over cluttered background. During training, for the vision-loss group, the binocular scotoma (created by the retinal lesions) will be outlined using a gaze-contingent system, so that the subject will see a border at the edge of their binocular scotoma that moves with gaze, alerting them to the location of the scotoma. In addition to the 16 training sessions, there will be longer (2.5 to 3 hours) measurement sessions: (1) before training; (2) after 8 training sessions; and (3) after 16 training sessions. Due to the number of procedures, the first measurement session might consist of two sessions. Thus, each participant with vision loss will participate in 19 or 20 sessions in total. Ideally, participants will attend for two visits per week. However, the schedule is flexible and can be adapted to a participants schedule.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Visual Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two-way mixed (one within, one between) factor study. Same training, applied to central vision loss group and normal vision control group viewing with simulated central scotomas.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    central vision loss
    Arm Type
    Experimental
    Arm Description
    will receive behavioral intervention
    Arm Title
    normal vision
    Arm Type
    Active Comparator
    Arm Description
    using simulated central scotomas, will receive behavioral intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Training of perception and oculo-motor control
    Intervention Description
    Behavioral training of eye movements and perception
    Primary Outcome Measure Information:
    Title
    reading speed following eight training sessions
    Description
    reading of paragraphs of text
    Time Frame
    comparing reading speed before intervention and after 8 sessions of training
    Title
    reading speed following sixteen training sessions
    Description
    reading of paragraphs of text
    Time Frame
    comparing reading speed before intervention and after 16 sessions of training
    Title
    face discrimination threshold following eight training sessions
    Description
    recognizing differences between faces
    Time Frame
    comparing face discrimination thresholds before intervention and after 8 sessions of training
    Title
    face discrimination threshold following sixteen training sessions
    Description
    recognizing differences between faces
    Time Frame
    comparing face discrimination thresholds before intervention and after 16 sessions of training
    Title
    video comprehension (shared word score) following eight training sessions
    Description
    understanding and describing the content of short video clips
    Time Frame
    comparing shared word scores before intervention and after 8 sessions of training
    Title
    video comprehension (shared word score) following sixteen training sessions
    Description
    understanding and describing the content of short video clips
    Time Frame
    comparing shared word scores before intervention and after 16 sessions of training
    Secondary Outcome Measure Information:
    Title
    PRL location relative to the location before the intervention (training)
    Description
    location of the preferred retinal locus measured from a retinal image obtained during a fixation examination
    Time Frame
    location at each of the 16 training sessions as compared to the location before intervention
    Title
    Oculo-motor reference location relative to the location before the intervention (training)
    Description
    first landing location of saccades to a new location measured using a gaze tracking system; measures whether there has been an adjustment of eye movement planning
    Time Frame
    at each of the 16 training sessions as compared to the location before intervention
    Title
    saccade dynamics relative to the location before the intervention (training)
    Description
    slope of the saccadic main sequence, which is the speed to distance relationship of saccades (fast eye movements), as measured using a gaze tracking system
    Time Frame
    at each of the 16 training sessions as compared to the location before intervention
    Title
    single-letter visual acuity following eight training sessions
    Description
    ability to read single letters of varying size
    Time Frame
    comparing visual acuity before intervention and after 8 sessions of training
    Title
    single-letter visual acuity following sixteen training sessions
    Description
    ability to read single letters of varying size
    Time Frame
    comparing visual acuity before intervention and after 16 sessions of training
    Title
    letter contrast sensitivity following eight training sessions
    Description
    ability to read "large" letters of low contrast
    Time Frame
    comparing letter contrast sensitivity before intervention and after 8 sessions of training
    Title
    letter contrast sensitivity following sixteen training sessions
    Description
    ability to read "large" letters of low contrast
    Time Frame
    comparing letter contrast sensitivity before intervention and after 16 sessions of training
    Title
    Geriatric Depression Scale (GDS) following eight training sessions
    Description
    evaluate depression and aspects of quality of life
    Time Frame
    comparing GDS scores before intervention and after 8 sessions of training
    Title
    Geriatric Depression Scale (GDS) following sixteen training sessions
    Description
    evaluate depression and aspects of quality of life
    Time Frame
    comparing GDS scores before intervention and after 16 sessions of training
    Title
    Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following eight training sessions
    Description
    measure of visual ability and vision-related limitations
    Time Frame
    comparing VA LV VFQ scores before intervention and after 8 sessions of training
    Title
    Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following sixteen training sessions
    Description
    measure of visual ability and vision-related limitations
    Time Frame
    comparing VA LV VFQ scores before intervention and after 16 sessions of training
    Other Pre-specified Outcome Measures:
    Title
    enrollment rate
    Description
    compares the number of participants who enroll in the study to the number of potential participants identified; and the time taken to enroll the study sample, and reasons for lack of willingness to participate (qualitative)
    Time Frame
    duration of enrollment period
    Title
    retention rate
    Description
    compares the number of participants who complete the study to the number of participants who enrolled in the study; and obtain reasons for dropout
    Time Frame
    duration of intervention period
    Title
    treatment fidelity
    Description
    adherence to the treatment session schedule, the adherence rate, any adherence pattern, and reasons for adherence failures
    Time Frame
    duration of intervention period
    Title
    measurement fidelity
    Description
    ability to obtain outcome measures (proportion of outcome measures completed, period and variance of improvement across subjects), obtain feedback on acceptability of outcome measures, and qualitative reasons for failure to complete specific outcome measures.
    Time Frame
    duration of intervention period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Central Vision Loss Group Inclusion Criteria: Bilateral foveal loss that includes the fovea in each eye, as determined through retinal examination fluent in English Cognitive function MoCA (Montreal Cognitive Assessment) test >20 Binocular visual acuity 20/800 or better able to sit for at least an hour Exclusion Criteria: speech impediment history of neurological or psychiatric disease inability to provide informed consent inability to follow instructions in English Normal Vision Control Group Inclusion Criteria: fluent in English Cognitive function MoCA (Montreal Cognitive Assessment) test >25 Binocular visual acuity 20/40 or better able to sit for at least an hour Exclusion Criteria: any ophthalmic disease that might impact on the conduct of the study, especially conditions that cause vision field loss speech impediment history of neurological or psychiatric disease inability to provide informed consent inability to follow instructions in English
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zoe E Roth, BME
    Phone
    617 912 2590
    Email
    zroth@meei.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Russell L Woods, PhD
    Organizational Affiliation
    Schepens Eye Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If approved by our IRB (Institutional Review Board), we may be able to share de-identified outcome metrics and eye movement measurements. A data use agreement would be required.

    Learn more about this trial

    Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus

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