Augmented Reality-Based Binocular Therapy for Visual Rehabilitation in Adults With Amblyopia (Ambly4Home)
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.
研究概览
地位
详细说明
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.
The study uses a randomized, placebo-controlled design in which both groups use the same mixed-reality device and follow the same training routine. The placebo condition preserves the device experience, duration, tasks, instructions, and home-use context but does not include the selective interocular contrast manipulation that produces active binocular rebalancing. This design allows the specific effect of the dichoptic treatment mechanism to be distinguished from nonspecific effects related to repeated visual activity, familiarity with the device, attention, and treatment expectations.
The home-based intervention is also designed to support objective monitoring of treatment exposure. Information such as session completion, effective training duration, interruptions, visual settings, task performance, adherence, and tolerability may be recorded to characterize the actual treatment dose and support individualized progression. Functional activities will be selected according to the participant's visual ability and safety, allowing the difficulty of the training to increase gradually as adaptation and visual performance improve.
In addition to determining the clinical effect of the binocular intervention, the study uses a multimodal assessment approach to characterize visual, retinal, and cortical changes associated with treatment and to investigate whether any improvements persist after treatment has ended. This approach is intended to provide a broader understanding of the functional and neurobiological response to home-based augmented reality binocular rehabilitation in adults with anisometropic amblyopia.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Rúben Magalhães, MSc
- 电话号码：+351 968918180
- 邮箱：rjcm@ess.ipp.pt
研究联系人备份
- 姓名：Catarina A Mateus, PhD
- 电话号码：+351 913474780
- 邮箱：cms@ess.ipp.pt
学习地点
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Coimbra District
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Coimbra、Coimbra District、葡萄牙、3000-548
- 招聘中
- Coimbra Institute for Biomedical Imaging and Translational Research (CIBIT), University of Coimbra
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首席研究员：
- Miguel Castelo-Branco, MD, PhD
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副研究员：
- João Castelhano, PhD
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副研究员：
- Sónia Pires, BSc
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副研究员：
- Sónia Afonso, MSc
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接触：
- Miguel Castelo-Branco, MD, PhD
- 电话号码：+351 239488510
- 邮箱：mcbranco@fmed.uc.pt
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副研究员：
- Otília Cardoso de Almeida, PhD
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Porto District
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Porto、Porto District、葡萄牙、4200-072
- 招聘中
- RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto
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首席研究员：
- Catarina Mateus, PhD
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副研究员：
- Nuno Rocha, PhD
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副研究员：
- Rúben Magalhães, MSc
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副研究员：
- Simão Ferreira, PhD
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副研究员：
- Inês Pais, MSc
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副研究员：
- Natália Almeida-Antunes, PhD
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副研究员：
- Filipe Coelho, MSc
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副研究员：
- Libânia Dias, BSc
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副研究员：
- Cleuber Alves, BSc
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接触：
- Nuno B Rocha, PhD
- 电话号码：+351 913474780
- 邮箱：nrocha@ess.ipp.pt
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Active augmented reality-based binocular therapy will be delivered using a Meta Quest 3 mixed-reality headset operating in passthrough mode.
Participants will complete 40-minute sessions four times per week for 10 weeks, initially learning to use the system in a clinical setting and subsequently continuing the training at home.
The real-world scene presented to the amblyopic eye will remain close to natural viewing, while the contrast presented to the dominant eye will be selectively reduced.
This controlled contrast reduction gives the amblyopic eye a relative visual advantage, encouraging its more active contribution during binocular viewing and promoting binocular integration.
The degree of contrast modulation will be adjusted according to visual performance over the course of treatment.
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安慰剂比较：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.
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Placebo augmented reality-based visual training will be delivered using the same Meta Quest 3 mixed-reality headset operating in passthrough mode, with the same session duration, training schedule, and home-based setting as the active intervention.
Participants will view and interact with their real-world surroundings while carrying out similar visual activities.
Unlike the active intervention, the contrast presented to the dominant eye will not be selectively reduced.
The visual information presented to both eyes will remain equivalent or will be only minimally and symmetrically modified, without providing active binocular rebalancing or a therapeutic visual advantage to the amblyopic eye.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at Week 10
大体时间：Baseline and Week 10
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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.
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Baseline and Week 10
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Near Stereoacuity at Week 10
大体时间：Baseline and Week 10
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Near stereoacuity will be assessed binocularly using a graded circles stereotest with polarized glasses and recorded in seconds of arc.
Measurable stereoacuity ranges from 400 to 20 seconds of arc.
Lower values indicate better stereoacuity.
Change from baseline will be calculated as the Week 10 value minus the baseline value.
A negative change indicates an improvement.
Participants unable to identify the largest disparity will be classified as having no measurable stereoacuity.
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Baseline and Week 10
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Change From Baseline in Interocular Suppression at Week 10
大体时间：Baseline and Week 10
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Interocular suppression will be assessed under binocular viewing conditions using a standardized suppression test.
The outcome will be the filter level at which binocular perception changes.
Change from baseline will be calculated as the Week 10 value minus the baseline value.
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Baseline and Week 10
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Change From Baseline in Cortical Population Receptive Field Size at Week 10
大体时间：Baseline and Week 10
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Cortical population receptive field (pRF) size will be assessed using functional magnetic resonance imaging (fMRI)-based retinotopic mapping.
Mean pRF size will be estimated separately for the early visual areas V1, V2, and V3.
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Baseline and Week 10
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Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
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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 6-month follow-up letter score minus the baseline letter score.
A positive change indicates an improvement in visual acuity.
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Baseline and 6 months after treatment completion
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Change From Baseline in Near Stereoacuity at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
|
Near stereoacuity will be assessed binocularly using a graded circles stereotest with polarized glasses and recorded in seconds of arc.
Measurable stereoacuity ranges from 400 to 20 seconds of arc.
Lower values indicate better stereoacuity.
Change from baseline will be calculated as the 6-month follow-up value minus the baseline value.
A negative change indicates an improvement.
Participants unable to identify the largest disparity will be classified as having no measurable stereoacuity.
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Baseline and 6 months after treatment completion
|
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Change From Baseline in Interocular Suppression at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
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Interocular suppression will be assessed under binocular viewing conditions using a standardized suppression test.
The outcome will be the filter level at which binocular perception changes.
Change from baseline will be calculated as the 6-month follow-up value minus the baseline value.
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Baseline and 6 months after treatment completion
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Change From Baseline in Static Achromatic Contrast Sensitivity in the Amblyopic Eye at Week 10
大体时间：Baseline and Week 10
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Static achromatic contrast sensitivity will be assessed monocularly in the amblyopic and fellow eyes using the MonCV3 system (Metrovision).
Sinusoidal gratings will be presented at a temporal frequency of 0 Hz and at spatial frequencies of 0.55, 1.1, 2.2, 3.4, 7.1, and 14.2 cycles per degree.
Results will be recorded in decibels (dB) separately for each eye and spatial frequency, with higher values indicating better contrast sensitivity.
Change from baseline will be calculated as the Week 10 value minus the baseline value.
A positive change indicates improvement.
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Baseline and Week 10
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Change From Baseline in Static Achromatic Contrast Sensitivity in the Amblyopic Eye at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
|
Static achromatic contrast sensitivity will be assessed monocularly in the amblyopic and fellow eyes using the MonCV3 system (Metrovision).
Sinusoidal gratings will be presented at a temporal frequency of 0 Hz and at spatial frequencies of 0.55, 1.1, 2.2, 3.4, 7.1, and 14.2 cycles per degree.
Results will be recorded in decibels (dB) separately for each eye and spatial frequency, with higher values indicating better contrast sensitivity.
Change from baseline will be calculated as the 6-month follow-up value minus the baseline value.
A positive change indicates improvement.
|
Baseline and 6 months after treatment completion
|
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Change From Baseline in Retinal Neuronal Layer Thicknesses at Week 10
大体时间：Baseline and Week 10
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Retinal structure will be assessed in the amblyopic and fellow eyes using the CIRRUS HD-OCT 5000 (ZEISS).
The outcome measures will include total macular thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and peripapillary retinal nerve fiber layer (RNFL) thickness.
Measurements will be recorded in micrometers (µm) and analyzed separately for each eye and prespecified retinal sector.
Change from baseline will be calculated as the Week 10 value minus the baseline value for each thickness parameter.
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Baseline and Week 10
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Change From Baseline in Retinal Neuronal Layer Thicknesses at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
|
Retinal structure will be assessed in the amblyopic and fellow eyes using the CIRRUS HD-OCT 5000 (ZEISS).
The outcome measures will include total macular thickness, macular ganglion cell-inner plexiform layer (GCIPL) thickness, and peripapillary retinal nerve fiber layer (RNFL) thickness.
Measurements will be recorded in micrometers (µm) and analyzed separately for each eye and prespecified retinal sector.
Change from baseline will be calculated as the 6-month follow-up value minus the baseline value for each thickness parameter.
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Baseline and 6 months after treatment completion
|
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Change From Baseline in Retinal Ganglion Cell Function Assessed by Pattern Electroretinography at Week 10
大体时间：Baseline and Week 10
|
Retinal ganglion cell function will be assessed in the amblyopic and fellow eyes using pattern electroretinography (PERG) recorded with the Tomey EP-1000 Pro system.
N95 amplitude, measured in microvolts (µV), and N95 implicit time, measured in milliseconds (ms), will be extracted and analyzed separately for each eye.
Change from baseline will be calculated as the Week 10 value minus the baseline value for each PERG parameter.
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Baseline and Week 10
|
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Change From Baseline in Retinal Ganglion Cell Function Assessed by Pattern Electroretinography at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
|
Retinal ganglion cell function will be assessed in the amblyopic and fellow eyes using pattern electroretinography (PERG) recorded with the Tomey EP-1000 Pro system.
N95 amplitude, measured in microvolts (µV), and N95 implicit time, measured in milliseconds (ms), will be extracted and analyzed separately for each eye.
Change from baseline will be calculated as the 6-month follow-up value minus the baseline value for each PERG parameter.
|
Baseline and 6 months after treatment completion
|
|
Change From Baseline in Cortical Population Receptive Field Size at 6-Month Follow-up
大体时间：Baseline and 6 months after treatment completion
|
Cortical population receptive field (pRF) size will be assessed using functional magnetic resonance imaging (fMRI)-based retinotopic mapping.
Mean pRF size will be estimated separately for the early visual areas V1, V2, and V3.
|
Baseline and 6 months after treatment completion
|
合作者和调查者
出版物和有用的链接
一般刊物
- Ziak P, Holm A, Halicka J, Mojzis P, Pinero DP. Amblyopia treatment of adults with dichoptic training using the virtual reality oculus rift head mounted display: preliminary results. BMC Ophthalmol. 2017 Jun 28;17(1):105. doi: 10.1186/s12886-017-0501-8.
- Levi DM. Rethinking amblyopia 2020. Vision Res. 2020 Nov;176:118-129. doi: 10.1016/j.visres.2020.07.014. Epub 2020 Aug 28.
- Pineles SL, Aakalu VK, Hutchinson AK, Galvin JA, Heidary G, Binenbaum G, VanderVeen DK, Lambert SR. Binocular Treatment of Amblyopia: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Feb;127(2):261-272. doi: 10.1016/j.ophtha.2019.08.024. Epub 2019 Oct 13.
- Bui Quoc E, Kulp MT, Burns JG, Thompson B. Amblyopia: A review of unmet needs, current treatment options, and emerging therapies. Surv Ophthalmol. 2023 May-Jun;68(3):507-525. doi: 10.1016/j.survophthal.2023.01.001. Epub 2023 Jan 18.
- Wang M, Ding J, Levi DM, Cooper EA. The Effect of Interocular Contrast Differences on the Appearance of Augmented Reality Imagery. ACM Transactions on Applied Perception. 2024;21(1):1-23. doi:10.1145/3617684.
- Thompson B, Concetta Morrone M, Bex P, Lozama A, Sabel BA. Harnessing brain plasticity to improve binocular vision in amblyopia: An evidence-based update. Eur J Ophthalmol. 2024 Jul;34(4):901-912. doi: 10.1177/11206721231187426. Epub 2023 Jul 10.
- Tan F, Yang X, Fan Y, Liao Y. The Study of Short-Term Plastic Visual Perceptual Training Based on Virtual and Augmented Reality Technology in Amblyopia. J Ophthalmol. 2022 Sep 1;2022:2826724. doi: 10.1155/2022/2826724. eCollection 2022.
- Hess RF, Thompson B. Amblyopia and the binocular approach to its therapy. Vision Res. 2015 Sep;114:4-16. doi: 10.1016/j.visres.2015.02.009. Epub 2015 Apr 20.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- ORT-2026-003
- COMPETE2030-FEDER-01469700 (其他赠款/资助编号：Portugal 2030 - COMPETE 2030)
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IPD 计划说明
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