- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07577219
Vision Rehabilitation Training With Multimodal Feedback in Central Vision Loss
Central vision loss from macular degeneration creates blind spots that impair reading, face recognition, and navigation. Individuals must learn to use peripheral vision, requiring retraining of eye movements. Our preliminary research using high-speed eye tracking demonstrated that people with larger scotomas have impaired eye movement control, and that single-session visual feedback training showed limited immediate benefit, though combining feedback types showed promise.
This study will evaluate whether extended binocular training (5 weekly sessions) with multimodal feedback improves eye movement control in 8-15 participants with bilateral central vision loss. Unlike conventional monocular rehabilitation systems, our approach trains both eyes simultaneously using real-time visual and auditory feedback during saccadic and smooth pursuit tasks. Participants will receive gaze-contingent scotoma awareness feedback, preferred retinal locus feedback, and auditory cues while performing eye tracking exercises.
Primary outcomes include saccadic accuracy (latency, landing error, amplitude) and smooth pursuit parameters (gain, tracking accuracy). Secondary outcomes include contrast sensitivity and self-reported visual function. Success could establish an evidence base for accessible home-based training using virtual reality technology, potentially benefiting millions with macular degeneration.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole C Ross, OD
- Phone Number: 6175875626
- Email: rossn@neco.edu
Study Contact Backup
- Name: Cecilia Idman-Rait, MPH
- Email: idmanraitc@neco.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- New England College of Optometry
-
Contact:
- Nicole C Ross, OD, MSc.
- Phone Number: 617-587-5626
- Email: rossn@neco.edu
-
Contact:
- Cecilia Idman-Rait, MPH
- Email: idmanraitc@neco.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Bilateral central scotomas confirmed via computerized tangent screen Visual acuity between 20/60 and 20/200 (0.5 - 1.00 logMAR) in either eye Stable central vision loss (no change in visual acuity >0.2 logMAR in past 6 months) Age 14 years or older, with diagnosis of macular disease Normal cognitive function (Mini-Mental State Examination score ≥24) Ability to provide informed consent and complete study visits No major hearing loss Fluent in English
Exclusion Criteria:
Unstable ocular disease (e.g., ongoing treatments and/or injections) Peripheral vision loss of less than 40 degrees Conditions affecting oculomotor control independent of CVL
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feedback Training
All participants will receive binocular oculomotor training with multimodal feedback.
Participants will complete 5 weekly training sessions (approximately 60 minutes each) performing saccadic and smooth pursuit eye movement exercises.
Training incorporates three types of feedback presented systematically across sessions: (1) scotoma awareness feedback via gaze-contingent black circle overlay representing the blind spot, (2) preferred retinal locus (PRL) feedback via dynamic gaze-contingent ring showing real-time fixation location, and (3) auditory feedback with tone modulation indicating fixation stability, PRL accuracy, and target acquisition.
Eye movements are recorded using binocular eye tracking at 2000Hz.
Contrast sensitivity is assessed intermittently during training using adaptive Gabor presentations.
Outcomes are measured at baseline (Week 0) and post-training (Week 6).
|
Participants will complete 5 weekly training sessions (approximately 60 minutes each) performing eye movement exercises while receiving real-time multimodal feedback. Training includes: Saccadic Training: Visually-guided saccades to targets appearing at randomized locations with instructions to use peripheral (inferior) retinal locus. Targets shift horizontally, vertically, and obliquely to train all saccadic directions. Smooth Pursuit Training: Circular pursuit of moving targets at 2.6°/s in randomized directions with instructions to maintain peripheral gaze above the target. Feedback Modalities (systematically varied across sessions):Scotoma Awareness: Gaze-contingent black circle overlay representing participant's blind spot; Preferred Retinal Locus (PRL) Feedback: Dynamic gaze-contingent ring showing real-time fixation location; Auditory Feedback: Tone modulation indicating fixation stability, PRL accuracy, and target acquisition success; Combined multimodal feedback |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Saccadic Accuracy (Landing Error)
Time Frame: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
Mean distance in degrees between saccade landing position and target location, measured using binocular eye tracking during visually-guided saccade tasks.
Lower values indicate better accuracy.
|
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Saccadic Latency
Time Frame: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
Time in milliseconds from target appearance to saccade initiation, measured using binocular eye tracking.
Faster latencies indicate improved oculomotor response.
|
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
|
Change in Smooth Pursuit Gain
Time Frame: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
Ratio of eye velocity to target velocity during smooth pursuit tasks (optimal gain = 1.0).
Higher gain values indicate better pursuit tracking accuracy.
|
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
|
Change in Number of Catch-up Saccades During Pursuit
Time Frame: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
Mean number of corrective saccades per trial during smooth pursuit tasks.
Fewer catch-up saccades indicate smoother, more accurate pursuit performance.
|
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
|
|
Change in Contrast Sensitivity Function
Time Frame: Baseline, Post-training (Week 6)
|
Area under the log contrast sensitivity function (AULCSF) measured using adaptive Gabor presentations during eye movement tasks.
Higher values indicate better contrast sensitivity.
|
Baseline, Post-training (Week 6)
|
|
Change in Fixation Stability
Time Frame: Baseline, Post-training (Week 6)
|
Area of the bivariate contour ellipse at 95% confidence interval of fixation positions during stationary target fixation tasks, measured in square degrees.
Smaller ellipse area indicates more stable fixation.
|
Baseline, Post-training (Week 6)
|
|
Change in Vision Related Quality of Life
Time Frame: At First study visit - Baseline, at last training session - week 5, and post training (week 11 )
|
Baseline, Post-training (Week 6)
|
At First study visit - Baseline, at last training session - week 5, and post training (week 11 )
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Eye Diseases
- Vision Disorders
- Sensation Disorders
- Retinal Diseases
- Blindness
- Retinal Degeneration
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Vision, Low
- Macular Degeneration
- Blindness, Cortical
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Feedback, Psychological
- Biofeedback, Psychology
Other Study ID Numbers
- Saccades 2.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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