Binocular Recovery Through Attention-based Visual Enhancement: A Randomized Controlled Trial (BRAVE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in Local Stereoacuity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Attention-Guided Dichoptic Visual Search Training (Behavioral)
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.
干预措施: Zero-Disparity Dichoptic Visual Search Task (Behavioral)
结局指标
主要结局
Change in Local Stereoacuity
时间窗: 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.
次要结局
- Change in Best-Corrected Visual Acuity (BCVA)(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Interocular Suppression Status(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Interocular Suppression Strength (Contrast Balance Ratio)(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Visual Evoked Potentials (VEPs)(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Electrophysiological Marker of Attentional Selection (N2pc Component)(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Behavioral Selective Attention(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Visual Search Efficiency(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Retention of Local Stereoacuity Gains(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Uncrossed Local Stereoacuity(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Global Stereoacuity(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Laboratory-Based Stereoacuity Threshold(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Visuomotor Coordination Completion Time and Kinematic Parameters(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)
- Change in Quality of Life Scores(Baseline (T0), Immediately Post-Training (T1), and 12-Week Follow-Up (T2).)