NCT06117813已完成不适用
Efficacy and Safety of the Nu.T for Improving Impaired Stereopsis Caused by Intermittent Exotropia : Multi Center, Randomized, Single-blind (Evaluator), Prospective Confirmatory Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nunaps Inc
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Changes in (log) arc second of stereopsis from Baseline to 8 weeks
研究概览
简要总结
This study evaluates the efficacy and safety of visual perceptual learning for improving stereopsis in intermittent exotropia. Half of participants will receive visual perceptual training using the Nu.T. The other half will not receive any training because there is no standard treatment for decreased stereopsis in intermittent exotropia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent Exotropia patients aged 6 to 15
- •Patients with decreased stereopsis above 50 arc seconds in Titmus Dot Test
- •Able to use the Virtual Reality(VR) device
- •Patient or legally authorized representative has signed the informed consent form
排除标准
- •Incomitant strabismus patient with impaired eye movement
- •Patients with amblyopia (Maximal corrective vision of one eye is less than 0.8 or maximal corrective vision both eyes more than two lines of difference)
- •History of ophthalmic surgery
- •Patient who has undergone or is currently undergoing cover treatment within one month for the purpose of treating strabismus or amblyopia
- •Scheduled for ophthalmic surgery during the clinical trial participation period (8 weeks in the treatment group as of the registration date, Maximum 16 weeks in the control group as of the registration date)
- •Difficult to understand and perform the stereopsis test.
- •Abnormal Retinal Correspondence
- •Patient with neurological abnormalities other than strabismus
- •History of premature birth
- •Participating in other clinical trial
- •Any other condition that, in the opinion of the investigator, precludes participation in the trial
结局指标
主要结局
Changes in (log) arc second of stereopsis from Baseline to 8 weeks
时间窗: 8 weeks
Stereopsis will be evaluated by a Titmus Dot Test.
次要结局
- Changes of Stereopsis based on Titmus Symbol Test from baseline to 8 weeks(8 weeks)
- Changes of convergence capability score from baseline to 8 weeks(8 weeks)
- Changes of Stereopsis based on Distance Randot Stereotest from baseline to 8 weeks(8 weeks)
- Changes of strabismus angle from baseline to 8 weeks(8 weeks)
- Changes of visuo-motor function from baseline to 8 weeks.(8 weeks)
- Proportion of subjects showing improved stereopsis at 8 weeks compared to baseline(8 weeks)
研究者
研究点 (6)
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