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Attention-based Binocular Training for Impaired Stereopsis (BRAVE) (BRAVE)

31. August 2026 aktualisiert von: Centre for Eye and Vision Research

Binocular Recovery Through Attention-based Visual Enhancement: A Randomized Controlled Trial (BRAVE Trial)

This study evaluates a novel attention-based binocular visual search training paradigm designed to improve stereopsis (stereo vision) in individuals with impaired binocular vision. Disruptions in balanced binocular input, such as from strabismus or anisometropia, often lead to deficient stereo vision, causing daily visuomotor limitations. While traditional therapies focus on monocular acuity, they frequently fail to restore stereopsis, especially in adults. The investigators propose a unique dichoptic visual search training method that embeds binocular disparity inside an attention-demanding task, encouraging cooperative binocular integration. Participants aged 18-39 with impaired stereopsis will be randomly assigned in a 1:1 ratio to either the active training group (disparity-embeded task) or the active control group (identical task with zero disparity). Both groups complete 5 training sessions over 5-6 weeks. Assessments will occur at baseline, immediately post-training, and at a 12-week follow-up. The primary objective is to determine if the active training group shows significantly greater improvements in local stereoacuity compared to the control group.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

56

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Hongkong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hongkong, HKG
        • Centre for Eye and Vision Research Limited
        • Unterermittler:
          • Tingni Li, PhD
        • Unterermittler:
          • Yu Yang
        • Hauptermittler:
          • Benjamin Thompson, PhD
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Krista Kelly, PhD
        • Unterermittler:
          • Lisa Christian, PhD
        • Unterermittler:
          • Xiaofei Hu, PhD
        • Unterermittler:
          • Ken WS Tan, PhD
      • Hong Kong, Hong Kong SAR, Hongkong, HKG
        • The Hong Kong Polytechnic University
        • Unterermittler:
          • Allen MY Cheong, PhD
        • Kontakt:
        • Hauptermittler:
          • Jeffrey TW Leung, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: Attention-Guided Dichoptic Visual Search Training
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.
Aktiver Komparator: 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.
Verhalten: Zero-Disparity Dichoptic Visual Search Task
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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Local Stereoacuity
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Retention of Local Stereoacuity Gains
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre for Eye and Vision Research

Mitarbeiter

The Hong Kong Polytechnic University
University of Waterloo

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

30. März 2029

Studienanmeldedaten

Zuerst eingereicht

31. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2026

Zuerst gepostet (Tatsächlich)

3. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RP1.4_BRAVE

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Anonymized data will be shared on request.

IPD-Sharing-Zeitrahmen

After publication of study results for an indefinite period.

IPD-Sharing-Zugriffskriterien

Upon reasonable request and approved by the study principal investigator.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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