Attention-based Binocular Training for Impaired Stereopsis (BRAVE) (BRAVE)
Binocular Recovery Through Attention-based Visual Enhancement: A Randomized Controlled Trial (BRAVE Trial)
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Jeffrey TW Leung, PhD
- Puhelinnumero: +852-64080394
- Sähköposti: jeffrey.tw.leung@polyu.edu.hk
Tutki yhteystietojen varmuuskopiointi
- Nimi: Benjamin Thompson, PhD
- Puhelinnumero: +852-31699631
- Sähköposti: ben.thompson@cevr.hk
Opiskelupaikat
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Hong Kong SAR
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Hong Kong, Hong Kong SAR, Hong Kong, HKG
- Centre for Eye and Vision Research Limited
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Alatutkija:
- Tingni Li, PhD
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Alatutkija:
- Yu Yang
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Päätutkija:
- Benjamin Thompson, PhD
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Ottaa yhteyttä:
- Benjamin Thompson, PhD
- Puhelinnumero: +852-31699631
- Sähköposti: ben.thompson@cevr.hk
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Ottaa yhteyttä:
- Tingni Li, PhD
- Puhelinnumero: +852-31699631
- Sähköposti: tingni.li@cevr.hk
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Alatutkija:
- Krista Kelly, PhD
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Alatutkija:
- Lisa Christian, PhD
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Alatutkija:
- Xiaofei Hu, PhD
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Alatutkija:
- Ken WS Tan, PhD
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Hong Kong, Hong Kong SAR, Hong Kong, HKG
- The Hong Kong Polytechnic University
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Alatutkija:
- Allen MY Cheong, PhD
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Ottaa yhteyttä:
- Jeffrey TW Leung, PhD
- Puhelinnumero: +852-64080394
- Sähköposti: jeffrey.tw.leung@polyu.edu.hk
-
Päätutkija:
- Jeffrey TW Leung, PhD
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Kokeellinen: 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.
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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.
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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.
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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).
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in Local Stereoacuity
Aikaikkuna: Baseline (T0) and Immediately Post-Training (T1, within 7 days after Session 5, approximately 5-6 weeks from baseline).
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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.
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Baseline (T0) and Immediately Post-Training (T1, within 7 days after Session 5, approximately 5-6 weeks from baseline).
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Retention of Local Stereoacuity Gains
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Uncrossed Local Stereoacuity
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Measured using the Randot Stereotest - Circles test with the test booklet rotated 180 degrees (log10 arcsec; nil stereopsis assigned 3000 arcsec).
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Global Stereoacuity
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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).
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Laboratory-Based Stereoacuity Threshold
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Psychophysical stereoacuity threshold (75% threshold in log10 arcsec) measured using a 4-alternative forced-choice staircase ring test administered dichoptically.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Best-Corrected Visual Acuity (BCVA)
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Monocular (affected/dominant eyes) and binocular distance visual acuity measured using an electronic ETDRS logMAR chart at 4 meters (recorded in logMAR units).
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Interocular Suppression Status
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Binocular status classified into categorical states (fusion, suppression, or diplopia) using the Worth 4-dot test at near (40 cm) and distance (3 m).
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Interocular Suppression Strength (Contrast Balance Ratio)
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Effective suppression depth quantified by the interocular contrast ratio at the perceptual balance point measured via a dichoptic letter-polarity task.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Visual Evoked Potentials (VEPs)
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Electrophysiological Marker of Attentional Selection (N2pc Component)
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Behavioral Selective Attention
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Spatial cueing effects on mean reaction time (ms) and response accuracy (%) derived from the modified spatial cueing task.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Visual Search Efficiency
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Visuomotor Coordination Completion Time and Kinematic Parameters
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Change in Quality of Life Scores
Aikaikkuna: Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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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.
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Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).
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Yhteistyökumppanit ja tutkijat
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Yhteistyökumppanit
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Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
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Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- RP1.4_BRAVE
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