Eye Recovery Automation for Post Injury Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Near Point of Convergence
研究概览
简要总结
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the clinical coordinators and technicians (programming the therapy) will know the therapy type. Investigators, clinical examiners, and data analysts, will be masked to therapy type until performing group level analysis.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria:
- •are aged 18 - 40;
- •have suffered a mTBI according to VA/Department of Defense (DoD) criteria with documented evidence of alteration of consciousness (AOC) < 24 hours or loss of consciousness (LOC) less than 30 minutes;
- •were injured between 1 month and 15 years ago;
- •received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;
- •experienced less than 24 hours of post-traumatic amnesia (PTA), if any;
- •have ongoing post-concussive symptoms as evidenced by a score of 18 or greater or a score of 2 or greater on question 6 (vision problems, blurring, trouble seeing) on the Neurobehavioral Symptom Inventory (NSI);
- •have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);
- •have PTCI as evidenced by obtaining a score of 21 or higher on the convergence insufficiency symptom survey (CISS), a specific measure of convergence insufficiency;
- •are fluent in English; and
- •have been on stable doses of any vision-altering medications for the past 2 months.
- •Stereopsis of 500 sec arc using Randot Stereo Test.
- •Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
- •Near point of convergence (NPC) > 5 cm
- •Convergence amplitude at near < 15PD break or the Sheard criterion not met
- •Control Inclusion Criteria:
- •are aged 18 - 40;
- •CISS score of 20 or lower;
- •near point of convergence (NPC) < 6cm; and
- •positive fusional range >15 prism diopters.
- •Stereopsis of 500 sec arc using Randot Stereo Test.
排除标准
- •prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
- •history of psychosis, as there are known visual performance findings associated with psychosis;
- •history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
- •recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
- •any condition that would prevent the participant from completing the protocol;
- •appointment of a legal representative, to avoid coercion of a vulnerable population;
- •any ongoing litigation related to TBI, to prevent interference with legal proceedings;
- •membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
- •Previous vergence therapy, orthoptics, home-based therapy, etc.
- •Amblyopia or constant strabismus or strabismus surgery.
- •High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia >1.5PD difference between eyes; Prior refractive surgery.
- •Manifest or latent nystagmus evident clinically.
- •Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).
研究组 & 干预措施
BNC Active
Binocularly normal controls receiving active therapy
干预措施: Virtual Eye Rotation Vision Exercise (VERVE) (Device)
BNC Sham
Binocularly normal controls receiving sham therapy
干预措施: Sham VR Therapy (Device)
PTCI Active
Post-traumatic Convergence Insufficiency participants receiving active therapy
干预措施: Virtual Eye Rotation Vision Exercise (VERVE) (Device)
PTCI Sham
Post-traumatic Convergence Insufficiency participants receiving sham therapy
干预措施: Sham VR Therapy (Device)
结局指标
主要结局
Near Point of Convergence
时间窗: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
Normal range is \< 6 cm
Positive Fusional Vergence
时间窗: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
Normal range is \>15 Prism Diopters
Objective Eye-Tracking Measures (Peak Velocity)
时间窗: Baseline (preintervention) and within 1 week after intervention
measured in degress/second
Objective Eye-Tracking Measures (Response Accuracy)
时间窗: Baseline (preintervention) and within 1 week after intervention
measured as a percentage of response divided by target amplitude
次要结局
- Brain Injury Vision Symptom Survey(Baseline (preintervention) and within 1 week after intervention)
- Neurobehavioral Symptom Inventory(Baseline (preintervention) and within 1 week after intervention)
- Convergence Insufficiency Symptom Survey(Baseline (preintervention) and within 1 week after intervention)
研究者
Chang Yaramothu
Assistant Professor
New Jersey Institute of Technology