Pilot Study To Evaluate The Efficacy Of Neurovision'S NVC™- Vision Correction Technology For The Improvement In Visual Acuity In Myopic Children And Slowing Down Of Myopia Progression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Manifest Subjective and Objective refraction
研究概览
简要总结
This is a pilot study to assess the effectiveness of Neurovision treatment in the improvement of vision in children being under-corrected and to assess the effectiveness of Neurovision treatment in slowing down myopia progression in children.
详细描述
NeuroVision's NVC vision correction technology is a non-invasive, patient-specific computerized treatment based on visual stimulation and facilitation of neural connections responsible for vision. NeuroVision's Neural Vision Correction TM (NVC) technology has been developed through research focused solely on optimizing performance of the neural or "back end" of the visual system, and is based on two decades of visual neuroscience research by the founder, Dr Uri Polat, whose work, which has been published in leading scientific journals, relates to understanding how the brain processes visual information, how neural activity is related to visual perception, and how visual processing interacts with other neural systems.
The technology has been clinically proven in the treatment of adult amblyopia, which until now has been considered untreatable, with a RCT in which follow-up of up to 2 years shows good retention of visual improvement. The company has received FDA 510(k) marketing clearance indicating NVC for the treatment of adult amblyopia in patients 9 years or older in the US. The company also received a Medical CE-Mark to market its Amblyopia and Low-Myopia products in the European Union. Company products are also approved for use in Israel by the Israeli Ministry of Health - Device License Authority. Additional proof-of-concept studies have been performed in Israel and Singapore indicating the technology's potential to improve vision of subjects having low myopia.
Today, NeuroVision commercially offers the Low Myopia treatment in Singapore. Initial results of the commercial treatment are even better than the proof-of-concept studies, emphasizing the importance of patient motivation and compliance in this treatment.
Based on the promising results of the Low Myopia treatment in adults, this study intends to evaluate the efficacy of NVC treatment in myopic children, by improving their quality of vision and reducing the progress rate of their Myopia.
The first objective of this study is to evaluate the improvement of visual acuity in children being under-corrected. As the myopia increases rapidly in many children, their habitual eyewear cannot match their exact degree of myopia on a day by day basis. As a result, many children suffer from reduced quality of vision (as shown also in data from the Singapore Cohort Study of the Risk Factors of Myopia [SCORM] study). Therefore, the first goal of this study is to evaluate the effectiveness of NeuroVision treatment in the improvement of the under-corrected visual acuity of these children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject's age is between 7 to 9 years.
- •The subject's cycloplegic refraction is at least -1.0DS in either eye.
- •The subject's manifest spherical equivalence does not differ by more than 1.0 D from cycloplegic spherical equivalence
- •The subject's visual acuity with an under correction of 1DS (compared to the manifest subjective VA), in both eyes, should not exceed 0.6 LogMAR.
- •The subject's best corrected visual acuity 0.04 LogMAR (either eye)
- •The subject is cognitively intact and is able to follow multiple step instructions.
- •The subject and his parents/legal guardians are very keen to improve the habitual visual acuity and to reduce the progression rate of myopia
- •The subject is able and willing to attend all study sessions and visits at the required frequency:
- •The total number of treatments is individual, approximately 30 and no more than
- •The required pace for the treatment sessions is at least 3 sessions per week.
- •No foreseen interruptions longer than 2 weeks during the treatment course.
- •The subject is able to cease contact lens wear from Baseline examination onwards until the end of the treatment period (phase I).
- •The subject's parent/legal guardian agrees to sign the Informed Consent Form (See Appendix D)
- •Subject's parent/legal guardian agrees to follow the study instruction including use of optical aids
排除标准
- •The subject suffers from any other eye disease(s) or other causes for the reduced visual acuity, aside from myopia and/or astigmatism.
- •The subject suffers from myopia-related visual complications resulting in visual loss, including myopic macular degeneration, myopic cataract and previous or pre-existing myopic retinal detachment.
- •The subject is suffering from Diabetes Mellitus.
- •The subject suffers from binocular vision problems, such as high exophoria / divergent squint / nystagmus
- •The subject has an activity limitation due to medical disorders (including migraines, seizure disorders, etc.), medications, or emotional status that might potentially impair the subject's ability to perform the treatment.
结局指标
主要结局
Manifest Subjective and Objective refraction
Accommodation amplitude, PRA and NRA
Distance visual acuity (Monocular and binocular Under-corrected Visual Acuity, and Best Corrected Visual Acuity - BCVA)
Cycloplegic Objective and Subjective refraction
Distance cycloplegic under-corrected visual acuity.
Contrast Sensitivity
Ocular axial length measurements
次要结局
未报告次要终点