PDF(Pubmed)
Abstract：
BACKGROUND: Interest in developing alternative methods for the treatment of amblyopia has long been a topic of interest among clinicians and researchers, as prescribed occlusion and penalization therapies do not always provide an effective response and are associated with a high risk of recurrence and non-compliance. Here, we present the protocol of a small-scale RCT to evaluate the safety and clinical efficacy of a novel VR-based system designed to provide binocular vision training to children with anisometropic amblyopia.
METHODS: We aim to recruit a total of 60 children with anisometropic amblyopia aged 5-17 years with no previous treatment for amblyopia other than refractive correction from the pediatric ophthalmology units of the University Clinical Hospital of Valladolid and the Vithas Medimar International Hospital of Alicante. Children who meet the eligibility criteria and consent to participate will be randomly assigned to a three-month intervention group of 18 half-hour in-office therapy sessions with the NEIVATECH system (group A) or to a parallel group receiving 2 hours of conventional patching per day at home for the same period of time (group B). Assessments of visual function will be carried out before the intervention and at 1, 2 and 3 months, with changes in distance BCVA being the primary outcome measure to be considered. Patient safety, compliance, satisfaction and acceptance to treatment will also be assessed after therapy as other valuable outcome measures. In addition, a rsfMRI scan will be performed on a subgroup of 5 patients from each group at the pre-intervention visit and at the post-intervention visit to test the effects of both therapies on neural plasticity in the visual cortex.
CONCLUSIONS: The NEIVATECH system has been conceived as a serious game designed to provide binocular vision training to anisometropic amblyopic children by complementing the concepts of perceptual learning, dichoptic training and gamification in an immersive VR environment. We hope that this novel approach may lead to greater improvements in vision performance than those provided so far by conventional patching in anisometropic amblyopic children.
BACKGROUND: This protocol was registered with ClinicalTrials.gov ( NCT04819386 ) on 29 March 2021.
METHODS: We aim to recruit a total of 60 children with anisometropic amblyopia aged 5-17 years with no previous treatment for amblyopia other than refractive correction from the pediatric ophthalmology units of the University Clinical Hospital of Valladolid and the Vithas Medimar International Hospital of Alicante. Children who meet the eligibility criteria and consent to participate will be randomly assigned to a three-month intervention group of 18 half-hour in-office therapy sessions with the NEIVATECH system (group A) or to a parallel group receiving 2 hours of conventional patching per day at home for the same period of time (group B). Assessments of visual function will be carried out before the intervention and at 1, 2 and 3 months, with changes in distance BCVA being the primary outcome measure to be considered. Patient safety, compliance, satisfaction and acceptance to treatment will also be assessed after therapy as other valuable outcome measures. In addition, a rsfMRI scan will be performed on a subgroup of 5 patients from each group at the pre-intervention visit and at the post-intervention visit to test the effects of both therapies on neural plasticity in the visual cortex.
CONCLUSIONS: The NEIVATECH system has been conceived as a serious game designed to provide binocular vision training to anisometropic amblyopic children by complementing the concepts of perceptual learning, dichoptic training and gamification in an immersive VR environment. We hope that this novel approach may lead to greater improvements in vision performance than those provided so far by conventional patching in anisometropic amblyopic children.
BACKGROUND: This protocol was registered with ClinicalTrials.gov ( NCT04819386 ) on 29 March 2021.
摘要：
背景：开发治疗弱视的替代方法的兴趣长期以来一直是临床医生和研究人员感兴趣的话题，因为规定的封堵和惩罚疗法并不总是提供有效的反应,并且与复发和不依从性的高风险相关.这里,我们提出了一种小规模RCT方案,以评估一种新型的基于VR的系统的安全性和临床疗效,该系统旨在为屈光参差性弱视儿童提供双眼视觉训练.
方法：我们的目标是从巴利亚多利德大学临床医院和阿利坎特维萨斯·梅迪玛国际医院的儿科眼科病房招募60名年龄为5-17岁的屈光参差性弱视儿童。符合资格标准并同意参加的儿童将被随机分配到为期三个月的干预组，使用NEIVATECH系统进行18个半小时的办公室治疗（A组），或接受2小时的常规治疗的平行组每天在家中进行相同的时间（B组）。视觉功能评估将在干预前和1、2和3个月进行，距离BCVA的变化是需要考虑的主要结果指标。患者安全,合规,对治疗的满意度和接受度也将在治疗后作为其他有价值的结局指标进行评估.此外,将在干预前访视和干预后访视时对每组5名患者的亚组进行rsfMRI扫描,以测试两种疗法对视皮层神经可塑性的影响.
结论：NEIVATECH系统被认为是一种严肃的游戏，旨在通过补充感知学习的概念，为屈光参差弱视儿童提供双眼视觉训练，在沉浸式VR环境中进行双重训练和游戏化。我们希望这种新颖的方法可以比迄今为止通过常规的屈光参差性弱视儿童修补方法提供的视力性能有更大的改善。
背景：该协议于2021年3月29日在ClinicalTrials.gov（NCT04819386）注册。
方法：我们的目标是从巴利亚多利德大学临床医院和阿利坎特维萨斯·梅迪玛国际医院的儿科眼科病房招募60名年龄为5-17岁的屈光参差性弱视儿童。符合资格标准并同意参加的儿童将被随机分配到为期三个月的干预组，使用NEIVATECH系统进行18个半小时的办公室治疗（A组），或接受2小时的常规治疗的平行组每天在家中进行相同的时间（B组）。视觉功能评估将在干预前和1、2和3个月进行，距离BCVA的变化是需要考虑的主要结果指标。患者安全,合规,对治疗的满意度和接受度也将在治疗后作为其他有价值的结局指标进行评估.此外,将在干预前访视和干预后访视时对每组5名患者的亚组进行rsfMRI扫描,以测试两种疗法对视皮层神经可塑性的影响.
结论：NEIVATECH系统被认为是一种严肃的游戏，旨在通过补充感知学习的概念，为屈光参差弱视儿童提供双眼视觉训练，在沉浸式VR环境中进行双重训练和游戏化。我们希望这种新颖的方法可以比迄今为止通过常规的屈光参差性弱视儿童修补方法提供的视力性能有更大的改善。
背景：该协议于2021年3月29日在ClinicalTrials.gov（NCT04819386）注册。
