Attention-based Binocular Training for Impaired Stereopsis (BRAVE) (BRAVE)
Binocular Recovery Through Attention-based Visual Enhancement: A Randomized Controlled Trial (BRAVE Trial)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jeffrey TW Leung, PhD
- Phone Number: +852-64080394
- Email: jeffrey.tw.leung@polyu.edu.hk
Study Contact Backup
- Name: Benjamin Thompson, PhD
- Phone Number: +852-31699631
- Email: ben.thompson@cevr.hk
Study Locations
-
-
Hong Kong SAR
-
Hong Kong, Hong Kong SAR, Hong Kong, HKG
- Centre for Eye and Vision Research Limited
-
Sub-Investigator:
- Tingni Li, PhD
-
Sub-Investigator:
- Yu Yang
-
Principal Investigator:
- Benjamin Thompson, PhD
-
Contact:
- Benjamin Thompson, PhD
- Phone Number: +852-31699631
- Email: ben.thompson@cevr.hk
-
Contact:
- Tingni Li, PhD
- Phone Number: +852-31699631
- Email: tingni.li@cevr.hk
-
Sub-Investigator:
- Krista Kelly, PhD
-
Sub-Investigator:
- Lisa Christian, PhD
-
Sub-Investigator:
- Xiaofei Hu, PhD
-
Sub-Investigator:
- Ken WS Tan, PhD
-
Hong Kong, Hong Kong SAR, Hong Kong, HKG
- The Hong Kong Polytechnic University
-
Sub-Investigator:
- Allen MY Cheong, PhD
-
Contact:
- Jeffrey TW Leung, PhD
- Phone Number: +852-64080394
- Email: jeffrey.tw.leung@polyu.edu.hk
-
Principal Investigator:
- Jeffrey TW Leung, PhD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-39 years (inclusive).
- Deficient or anomalous stereoscopic vision with a stereoacuity >= 70 sec arc or unmeasurable stereoacuity.
- Best corrected visual acuity (BCVA) of < 0.80 logMAR in both eyes, with at least one eye having a visual acuity of <= 0.1 logMAR (uncorrected or corrected-to-normal with glasses or contact lenses).
- Normal colour vision.
- Good general health.
Exclusion Criteria:
- Previous history of ocular surgery (except for refractive correction surgery, where appropriate).
- Pre-existing ocular conditions or medications that affect vision or visual function.
- Pre-existing conditions or medications that affect neuropsychological function.
- Presence of strabismus over 10 prism diopters at distance in current refractive correction measured by simultaneous prism and cover test, or large eccentric fixation.
- Previous history of experiencing double vision (diplopia).
- Identified at risk of developing diplopia due to binocular state and/or poor binocular control.
- Inability to comprehend psychophysical test instructions given and/or consent for themselves.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Active Training Group
Participants complete a dichoptic visual search task where the search target is uniquely paired with crossed binocular disparity under balanced interocular contrast.
The training consists of 5 sessions (5 blocks of 192 trials per session) over 5-6 weeks with adaptive disparity adjustment.
|
A computer-based dichoptic training paradigm in which visual stimuli are presented separately to each eye under balanced interocular contrast .
Participants search for conjunction-defined targets across 5 sessions (5 blocks of 192 trials per session).
The target stimulus is uniquely paired with crossed binocular disparity to provide depth-based attentional guidance, with target disparity adaptively reduced based on search performance.
|
|
Active Comparator: Active Control Group
Participants perform an identical computer-based dichoptic visual search task with the same geometric stimuli, trial structure (5 blocks of 192 trials per session), and interocular contrast balancing, but with zero binocular disparity.
|
An active control dichoptic task identical in visual stimuli, trial structure (5 sessions; 5 blocks of 192 trials per session), and interocular contrast balancing to the training arm, but presented with zero binocular disparity (all stimuli appear in the same depth plane without depth cues).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Local Stereoacuity
Time Frame: Baseline (T0) and Immediately Post-Training (T1, within 7 days after Session 5, approximately 5-6 weeks from baseline).
|
Measured using the Randot Stereotest - Circles test (graded disparities from 400 to 20 arcsec, 10 levels) under standardized lighting at 40 cm.
The score is recorded as the finest disparity correctly identified (in log arcseconds).
Nil stereopsis is assigned 3000 arcsec (3.477 log arcsec).
The primary metric is the between-group difference in the change score.
|
Baseline (T0) and Immediately Post-Training (T1, within 7 days after Session 5, approximately 5-6 weeks from baseline).
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention of Local Stereoacuity Gains
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Measured using the Randot Stereotest - Circles test under crossed disparity (log10 arcsec; nil stereopsis assigned 3000 arcsec) to evaluate long-term maintenance of training effects
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Uncrossed Local Stereoacuity
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Measured using the Randot Stereotest - Circles test with the test booklet rotated 180 degrees (log10 arcsec; nil stereopsis assigned 3000 arcsec).
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Global Stereoacuity
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Measured with the Randot Preschool Stereotest (random-dot stereograms, 800 to 40 arcsec, 6 levels) under both crossed and uncrossed disparity conditions (log10 arcsec; nil stereopsis assigned 3000 arcsec).
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Laboratory-Based Stereoacuity Threshold
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Psychophysical stereoacuity threshold (75% threshold in log10 arcsec) measured using a 4-alternative forced-choice staircase ring test administered dichoptically.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Best-Corrected Visual Acuity (BCVA)
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Monocular (affected/dominant eyes) and binocular distance visual acuity measured using an electronic ETDRS logMAR chart at 4 meters (recorded in logMAR units).
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Interocular Suppression Status
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Binocular status classified into categorical states (fusion, suppression, or diplopia) using the Worth 4-dot test at near (40 cm) and distance (3 m).
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Interocular Suppression Strength (Contrast Balance Ratio)
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Effective suppression depth quantified by the interocular contrast ratio at the perceptual balance point measured via a dichoptic letter-polarity task.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Visual Evoked Potentials (VEPs)
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Peak latencies (ms) and amplitudes (μV) of the transient pattern-reversal VEP N75-P100-N135 complex across high-contrast and isoluminant red-green conditions, alongside harmonic amplitudes/phases (2F, 4F) from steady-state VEPs, recorded via a 64-channel EEG system.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Electrophysiological Marker of Attentional Selection (N2pc Component)
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Mean amplitude (μV) of the posterior contralateral-minus-ipsilateral difference wave (N2pc) extracted across predefined parieto-occipital electrodes (P7, PO7, P8, PO8) during a modified spatial cueing task.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Behavioral Selective Attention
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Spatial cueing effects on mean reaction time (ms) and response accuracy (%) derived from the modified spatial cueing task.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Visual Search Efficiency
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Visual search slope (reaction time as a function of set size, in ms/item) measured from a 192-trial zero-disparity dichoptic visual search task.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Visuomotor Coordination Completion Time and Kinematic Parameters
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Visuomotor dexterity and kinematic performance are assessed using the Grooved Pegboard Test separately for dominant and non-dominant hands.
Hand movements during the task are video recorded for detailed kinematic tracking.
The primary quantitative metric for this outcome is the total completion time (in seconds) required to successfully place all 25 grooved pegs (shorter duration indicates better motor speed and coordination).
Secondary kinematic metrics extracted from video analyses include mean peg-insertion duration (seconds), inter-peg temporal variability across the 25 trials (coefficient of variation, CV), and total drop/error counts.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
|
Change in Quality of Life Scores
Time Frame: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Domain scores assessed via the World Health Organization Quality of Life Instrument-Short Form (WHO QoL-BREF) and the Amblyopia and Strabismus Questionnaire (A&SQ).
Higher scores indicate superior functional visual ability and quality of life.
For both questionnaires, domain and composite scores are linearly transformed to a standardized 0 to 100 scale, where higher scores represent superior functional visual ability, fewer daily limitations, and better overall quality of life.
|
Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Refractive Errors
- Vision Disorders
- Sensation Disorders
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Amblyopia
- Strabismus
- Anisometropia
Other Study ID Numbers
Other Study ID Numbers
- RP1.4_BRAVE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.