An interventional study of Training of perception and oculo-motor control in Central Visual Impairment, sponsored by Russell L. Woods. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Russell L. Woods · Not applicable, Interventional, and Treatment
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).
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.
308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 211 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →This is the only study on the registry with Russell L. Woods as lead sponsor.
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Central Vision Loss Group
Inclusion Criteria:
Exclusion Criteria:
Normal Vision Control Group
Inclusion Criteria:
Exclusion Criteria:
will receive behavioral intervention
Behavioral: Training of perception and oculo-motor control
using simulated central scotomas, will receive behavioral intervention
Behavioral: Training of perception and oculo-motor control
Behavioral training of eye movements and perception
reading speed following eight training sessions
reading of paragraphs of text
Time frame: comparing reading speed before intervention and after 8 sessions of training
reading speed following sixteen training sessions
reading of paragraphs of text
Time frame: comparing reading speed before intervention and after 16 sessions of training
face discrimination threshold following eight training sessions
recognizing differences between faces
Time frame: comparing face discrimination thresholds before intervention and after 8 sessions of training
face discrimination threshold following sixteen training sessions
recognizing differences between faces
Time frame: comparing face discrimination thresholds before intervention and after 16 sessions of training
video comprehension (shared word score) following eight training sessions
understanding and describing the content of short video clips
Time frame: comparing shared word scores before intervention and after 8 sessions of training
video comprehension (shared word score) following sixteen training sessions
understanding and describing the content of short video clips
Time frame: comparing shared word scores before intervention and after 16 sessions of training
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
Time frame: location at each of the 16 training sessions as compared to the location before intervention
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
Time frame: at each of the 16 training sessions as compared to the location before intervention
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
Time frame: at each of the 16 training sessions as compared to the location before intervention
single-letter visual acuity following eight training sessions
ability to read single letters of varying size
Time frame: comparing visual acuity before intervention and after 8 sessions of training
single-letter visual acuity following sixteen training sessions
ability to read single letters of varying size
Time frame: comparing visual acuity before intervention and after 16 sessions of training
letter contrast sensitivity following eight training sessions
ability to read "large" letters of low contrast
Time frame: comparing letter contrast sensitivity before intervention and after 8 sessions of training
letter contrast sensitivity following sixteen training sessions
ability to read "large" letters of low contrast
Time frame: comparing letter contrast sensitivity before intervention and after 16 sessions of training
Geriatric Depression Scale (GDS) following eight training sessions
evaluate depression and aspects of quality of life
Time frame: comparing GDS scores before intervention and after 8 sessions of training
Geriatric Depression Scale (GDS) following sixteen training sessions
evaluate depression and aspects of quality of life
Time frame: comparing GDS scores before intervention and after 16 sessions of training
Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following eight training sessions
measure of visual ability and vision-related limitations
Time frame: comparing VA LV VFQ scores before intervention and after 8 sessions of training
Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following sixteen training sessions
measure of visual ability and vision-related limitations
Time frame: comparing VA LV VFQ scores before intervention and after 16 sessions of training
enrollment rate
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
retention rate
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
treatment fidelity
adherence to the treatment session schedule, the adherence rate, any adherence pattern, and reasons for adherence failures
Time frame: duration of intervention period
measurement fidelity
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
No study locations are listed for this record.
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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