Effectiveness of Vision Therapy in a Virtual Reality Headset
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Positive Fusional Vergence
研究概览
简要总结
The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Examiner (Outcomes Assessor) will be masked by pooling participants from another study.
入排标准
- 年龄范围
- 9 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 9 years and older
- •CISS score ≥ 16
- •Best-corrected distance visual acuity of 20/25 or better in each eye
- •Random dot stereopsis appreciation of 500 seconds of arc or better
- •Parent or subject understands the protocol and is willing to enroll in the study
排除标准
- •Constant strabismus at distance or near
- •Vertical heterophoria ≥ 2 ∆ at distance or near
- •≥ 2 line interocular difference in best-corrected visual acuity
- •Near point of accommodation > 20 cm in either eye as measured by push-up method
- •Manifest or latent nystagmus
- •Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain
- •Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease
- •Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
- •Inability to comprehend and/or perform any study-related test or procedure
结局指标
主要结局
Positive Fusional Vergence
时间窗: up to 4 weeks post-therapy
Normal range is \>15 Prism Diopters
Near Point of Convergence
时间窗: up to 4 weeks post-therapy
Normal range is \< 6 cm
次要结局
- Convergence Insufficiency Symptom Survey (CISS)(up to 4 weeks post-therapy)
- Vision Quality of Life with Time Survey (VisQuaL-T)(up to 4 weeks post-therapy)
- Core Elements of Gaming Experience Questionnaire(up to 4 weeks post-therapy)