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

31 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

56

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Benjamin Thompson, PhD
  • Número de teléfono: +852-31699631
  • Correo electrónico: ben.thompson@cevr.hk

Ubicaciones de estudio

  • Hong Kong
    • Hong Kong SAR
      • Hong Kong, Hong Kong SAR, Hong Kong, HKG
        • Centre for Eye and Vision Research Limited
        • Sub-Investigador:
          • Tingni Li, PhD
        • Sub-Investigador:
          • Yu Yang
        • Investigador principal:
          • Benjamin Thompson, PhD
        • Contacto:
          • Benjamin Thompson, PhD
          • Número de teléfono: +852-31699631
          • Correo electrónico: ben.thompson@cevr.hk
        • Contacto:
          • Tingni Li, PhD
          • Número de teléfono: +852-31699631
          • Correo electrónico: tingni.li@cevr.hk
        • Sub-Investigador:
          • Krista Kelly, PhD
        • Sub-Investigador:
          • Lisa Christian, PhD
        • Sub-Investigador:
          • Xiaofei Hu, PhD
        • Sub-Investigador:
          • Ken WS Tan, PhD
      • Hong Kong, Hong Kong SAR, Hong Kong, HKG
        • The Hong Kong Polytechnic University
        • Sub-Investigador:
          • Allen MY Cheong, PhD
        • Contacto:
        • Investigador principal:
          • Jeffrey TW Leung, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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.
Comparador activo: 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.
Conductual: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Local Stereoacuity
Periodo de tiempo: 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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Retention of Local Stereoacuity Gains
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Centre for Eye and Vision Research

Colaboradores

The Hong Kong Polytechnic University
University of Waterloo

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

30 de marzo de 2029

Fechas de registro del estudio

Enviado por primera vez

31 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2026

Publicado por primera vez (Actual)

3 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RP1.4_BRAVE

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Anonymized data will be shared on request.

Marco de tiempo para compartir IPD

After publication of study results for an indefinite period.

Criterios de acceso compartido de IPD

Upon reasonable request and approved by the study principal investigator.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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