Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at Week 10
研究概览
简要总结
The goal of this clinical trial is to evaluate a home-based augmented reality-based binocular therapy designed to improve visual function in adults aged 18 to 40 years with unilateral anisometropic amblyopia, commonly called "lazy eye." The therapy is designed to be used during everyday activities, allowing visual training to be integrated into the participant's normal home routine.
The main questions this study aims to answer are:
- Does the Ambly4Home augmented reality-based binocular therapy improve visual acuity in the amblyopic eye and binocular vision compared with placebo visual training?
- Are any improvements in visual function maintained 6 months after the treatment has ended?
- Is the treatment associated with changes in other measures of visual function, retinal structure and function, and visual brain function?
Participants will be randomly assigned to receive either active binocular therapy or placebo visual training. Both groups will use the same mixed-reality device, follow the same training schedule, and carry out similar daily activities while viewing their real-world surroundings through the device. In the active treatment, the image presented to the amblyopic eye will remain close to the natural scene, while the contrast of the image presented to the stronger eye will be selectively lowered. This gives the amblyopic eye a relative visual advantage, helping to rebalance the input from the two eyes and encouraging them to work together.
In the placebo group, participants will use the same device under the same conditions, but without the selective contrast reduction used in the active treatment. This comparison will allow researchers to isolate the specific effect of selectively lowering the contrast seen by the stronger eye.
Participants will:
- Complete 40-minute training sessions four times per week for 10 weeks.
- Learn how to use the system in a clinical setting before continuing the training at home.
- Attend assessment visits before treatment, after 10 weeks of treatment, and 6 months after treatment has ended.
- Complete tests of visual acuity, depth perception, suppression between the eyes, and contrast sensitivity, as well as retinal imaging, retinal function testing, and brain imaging.
详细描述
Amblyopia is a neurodevelopmental disorder characterized not only by reduced visual acuity in the amblyopic eye but also by abnormal interaction between the two eyes, including interocular suppression and impaired binocular integration. Although treatment has traditionally focused on childhood, evidence of residual visual plasticity in adults has supported the development of binocular and dichoptic approaches aimed at restoring a more balanced contribution from both eyes.
Dichoptic therapy simultaneously stimulates both eyes while presenting different visual inputs to each eye. A common strategy is to reduce the strength of the image presented to the stronger eye, allowing the amblyopic eye to contribute more effectively during binocular viewing. This approach differs from conventional occlusion because visual information from both eyes remains available throughout treatment.
The intervention evaluated in this study is designed to adapt this therapeutic principle to the daily life of adults with amblyopia. In contrast to fully immersive virtual reality approaches that require participants to interrupt their usual activities and engage in dedicated virtual tasks or games, the intervention uses a Meta Quest 3 mixed-reality headset operating in passthrough mode. Participants can therefore continue to view and interact with their real-world environment while controlled visual processing is applied separately to each eye. The intervention is intended to integrate binocular visual rehabilitation into functional activities performed in the home environment.
During active treatment, the real-world scene presented to the amblyopic eye is preserved as close as possible to natural viewing conditions. The dominant eye receives the same spatially corresponding scene, but with a controlled reduction in contrast. This contrast manipulation reduces the functional advantage of the dominant eye without completely removing its visual information, creating a relative visual advantage for the amblyopic eye and encouraging its more active participation during binocular viewing. The intervention therefore aims to progressively rebalance the contribution of the two eyes rather than replace binocular vision with monocular viewing.
The degree of contrast modulation will be individualized according to the participant's visual function and adjusted throughout treatment according to visual performance. As visual function improves, the contrast difference between the eyes can be progressively reduced, bringing the visual inputs closer to natural binocular viewing conditions. This adaptive approach is intended to maintain an appropriate therapeutic challenge while avoiding unnecessary or excessive penalization of the dominant eye.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 40 years.
- •Diagnosis of anisometropic amblyopia, defined as unilateral amblyopia with an interocular difference of at least 2 lines in best-corrected visual acuity (BCVA), with BCVA worse than 20/32 in the more affected eye.
排除标准
- •Amblyopia other than anisometropic amblyopia.
- •Bilateral amblyopia.
- •Ophthalmologic or neuro-ophthalmologic disease other than amblyopia.
- •Neurological disease, chronic pharmacological therapy, or implanted medical devices.
- •Any ocular surgery or ocular treatment within the previous year.
- •Significant media opacities that may prevent fundus examination.
- •Inability to provide informed consent.
研究组 & 干预措施
Active Augmented Reality-Based Binocular Therapy
Participants will receive active augmented reality-based binocular therapy for 10 weeks, with 40-minute sessions four times per week, initially in a clinical setting and subsequently at home.
干预措施: Active Augmented Reality-Based Binocular Therapy (Device)
Placebo Augmented Reality-Based Visual Training
Participants will receive placebo augmented reality-based visual training for 10 weeks, with 40-minute sessions four times per week, using the same mixed-reality device and training schedule as the active group.
干预措施: Placebo Augmented Reality-Based Visual Training (Device)
结局指标
主要结局
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at Week 10
时间窗: Baseline and Week 10
Best-corrected visual acuity of the amblyopic eye will be assessed monocularly using a standardized ETDRS chart and recorded as the number of letters correctly identified. Higher ETDRS letter scores indicate better visual acuity. Change from baseline will be calculated as the Week 10 letter score minus the baseline letter score. A positive change indicates an improvement in visual acuity.
次要结局
- Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 6-Month Follow-up(Baseline and 6 months after treatment completion)
- Change From Baseline in Near Stereoacuity at Week 10(Baseline and Week 10)
- Change From Baseline in Near Stereoacuity at 6-Month Follow-up(Baseline and 6 months after treatment completion)
- Change From Baseline in Interocular Suppression at Week 10(Baseline and Week 10)
- Change From Baseline in Interocular Suppression at 6-Month Follow-up(Baseline and 6 months after treatment completion)
- Change From Baseline in Static Achromatic Contrast Sensitivity in the Amblyopic Eye at Week 10(Baseline and Week 10)
- Change From Baseline in Static Achromatic Contrast Sensitivity in the Amblyopic Eye at 6-Month Follow-up(Baseline and 6 months after treatment completion)
- Change From Baseline in Retinal Neuronal Layer Thicknesses at Week 10(Baseline and Week 10)
- Change From Baseline in Retinal Neuronal Layer Thicknesses at 6-Month Follow-up(Baseline and 6 months after treatment completion)
- Change From Baseline in Retinal Ganglion Cell Function Assessed by Pattern Electroretinography at Week 10(Baseline and Week 10)
- Change From Baseline in Retinal Ganglion Cell Function Assessed by Pattern Electroretinography at 6-Month Follow-up(Baseline and 6 months after treatment completion)
- Change From Baseline in Cortical Population Receptive Field Size at Week 10(Baseline and Week 10)
- Change From Baseline in Cortical Population Receptive Field Size at 6-Month Follow-up(Baseline and 6 months after treatment completion)
研究者
Catarina Mateus, PhD
Associate Professor
Polytechnic Institute of Porto