Attention-based Binocular Training for Impaired Stereopsis (BRAVE) (BRAVE)
2026년 8월 31일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
56
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Jeffrey TW Leung, PhD
- 전화번호: +852-64080394
- 이메일: jeffrey.tw.leung@polyu.edu.hk
연구 연락처 백업
- 이름: Benjamin Thompson, PhD
- 전화번호: +852-31699631
- 이메일: ben.thompson@cevr.hk
연구 장소
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Hong Kong SAR
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Hong Kong, Hong Kong SAR, 홍콩, HKG
- Centre for Eye and Vision Research Limited
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부수사관:
- Tingni Li, PhD
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부수사관:
- Yu Yang
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수석 연구원:
- Benjamin Thompson, PhD
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연락하다:
- Benjamin Thompson, PhD
- 전화번호: +852-31699631
- 이메일: ben.thompson@cevr.hk
-
연락하다:
- Tingni Li, PhD
- 전화번호: +852-31699631
- 이메일: tingni.li@cevr.hk
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부수사관:
- Krista Kelly, PhD
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부수사관:
- Lisa Christian, PhD
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부수사관:
- Xiaofei Hu, PhD
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부수사관:
- Ken WS Tan, PhD
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Hong Kong, Hong Kong SAR, 홍콩, HKG
- The Hong Kong Polytechnic University
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부수사관:
- Allen MY Cheong, PhD
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연락하다:
- Jeffrey TW Leung, PhD
- 전화번호: +852-64080394
- 이메일: jeffrey.tw.leung@polyu.edu.hk
-
수석 연구원:
- Jeffrey TW Leung, PhD
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Local Stereoacuity
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Retention of Local Stereoacuity Gains
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 11월 1일
기본 완료 (추정된)
기본 완료
2028년 12월 31일
연구 완료 (추정된)
연구 완료
2029년 3월 30일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 31일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 31일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 31일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- RP1.4_BRAVE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Anonymized data will be shared on request.
IPD 공유 기간
After publication of study results for an indefinite period.
IPD 공유 액세스 기준
Upon reasonable request and approved by the study principal investigator.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .