A Phase 3 Randomized, Single-blind, Multicenter, Clinical Control Study to Evaluate the Efficacy and Safety of Caterna Virtual Reality Facilitating Treatment Patients With Amblyopia in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Effectiveness of amblyopia treatment with VR
研究概览
简要总结
It aims to find the effectiveness and the safety of Virtual Reality (Caterna, DOBOSO, item code: SJ-VRS2018) to facilitate amblyopia treatment combining spectacles and occlusion. And it also aims to test whether amblyopia treatment outcomes with spectacles, occlusion and VR are significant better than those without VR, but with spectacles and occlusion.
The experiment arm is designed to use the Caterna VR to treat amblyopia for total consistent 13 weeks, 3 times per week, while the control arm is not.
Both arms are best optical correction and with patch the non-amblyopia eye 2 hours or 6 hours per day.
All eyes are followed up for total 13 weeks.
详细描述
The amblyopia eye will see the video content from Caterna VR a little bit earlier (12 ms) than the other non-amblyopia eye.
Also, the illumination and contrast are both adjusted to balance 2 eyes' clarity.
One VR treatment sequence is 30 minutes with 5 minutes break in the middle.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Research centers are used as a stratification factor. The researchers include subjects in the trial group or control group based on randomized envelopes.
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages from 4~12 years old (including 4 years or 12 years old）；
- •According to the Chinese Medical Association Ophthalmology branch: Strabismus and Pediatric Ophthalmology Experts "Consensus of Amblyopia Diagnosis " (2011) as the standard to be diagnosed as amblyopia with abnormal vision than that of age-based norms, that is, caused by abnormal visual development due to strabismus, uncorrected refractive error or form deprivation, the best corrected vision acuity of single eye or both eyes below age-based norms; Or 2 eyes' vision acuity difference larger than 2 lines or more. The normal minimum limit of vision acuity for children of different ages are as the followings: The normal minimum limit of vision acuity for children aged 4 to 5 years is 0.5 (decimal vision acuity); And the normal minimum limit of vision acuity for children aged 6 and over is 0.7(decimal vision acuity).
- •The subject's supervision is fully understand the purpose of the trial and sign an informed consent form; And the subject can cooperate with the whole treatment and related eye examinations。 -
排除标准
- •Subjects suffered from tumors, heart disease, hypertension (blood pressure top limitation of children aged 4 to 6 years: 110/70 mmHg, blood pressure top limitation of children aged 7 to 12 years: 120/80 mmHg), or epilepsy;
- •The subject has implanted electronic devices, such as pacemakers, etc.
- •The subject had or has a mental illness;
- •Any eye of the subject due to keratitis, conjunctivitis, internal turning eyelashes and other diseases leading to photophobia or continuing tears;
- •Subject suffered from vertigo, acrophobia or traumatic brain lesions;
- •The subject's eye has congenital glaucoma, congenital ptosis, dacryocystitis, trauma and other significant vision related lesions;
- •Subject received a masking therapy or a treatment instrument for amblyopia treatment before joining this study;
- •The subject participated in other clinical trials before joining this study;
- •For safety reasons or for the benefit of patients, the researchers believe that the patient should not participate in other conditions, such as suffering from a certain severe heart, liver or kidney disease.
结局指标
主要结局
Effectiveness of amblyopia treatment with VR
时间窗: 13 weeks
General Effectiveness=Number of both cured eyes and effective eyes from total number×100%
次要结局
- Stereopsis: distance and near, respectively(13 weeks)
- Contrast sensitivity function(CSF)(13 weeks)
- Effectiveness of 8 weeks' VR amblyopia treatment(8 weeks)
- Effectiveness of 4 weeks' VR amblyopia treatment(4 weeks)