PILOT CLINICAL TRIAL (PCT) of the Natural History of the Most Common MTBI-related Oculomotor Disorder Convergence Insufficiency & the Effectiveness of Vergence/Accommodative Therapy for MTBI-related Convergence Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Clinical Composite Measure
研究概览
简要总结
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.
详细描述
The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of interventions or therapies. In this application, we refer to this pilot and feasibility study as a pilot clinical trial (PCT). This feasibility PCT aims to identify potential challenges, logistical issues, and unforeseen complications. To do this, we will examine various feasibility aspects, including recruitment and retention, randomization, intervention protocols, outcome measures, ethical considerations, safety monitoring, resource availability, and stakeholder feedback. By conducting this PCT, we can test our procedures and gather preliminary data. The primary objectives of this feasibility PCT are to 1) Determine the feasibility of conducting future full-scale RCTs by evaluating the effectiveness of a novel vergence/accommodative/move (OBVAM) therapy program for young adults with mTBI-CI and 2) Better understand the progression and stability (i.e., natural history) of mTBI-CI over the 6 weeks following enrollment.
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 (Investigator)
盲法说明
The examiner who performs the sensory-motor vision examination will be masked to the assigned treatment group
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age 18 to 35 years inclusive
- •Medical diagnosis of mTBI or concussion > 1 month ago and no longer than 6 months ago
- •Convergence Insufficiency Symptom (CISS score) ≥ 21
- •Best-corrected VA of 20/25 or better in both eyes at distance & near
- •Willingness to wear refractive correction, if indicated
- •Random dot stereopsis of 500 arcsec or better (Randot Stereo Test)
- •Receded NPC of ≥6 cm
- •Insufficient PFV (< 15∆ or PFV blur point less than twice the near exophoria magnitude)
- •Wearing refractive correction for cycloplegic refractive errors of:
- •≥ +1.25 D SE hyperopia or ≥ -1.00 D SE myopia in either eye
- •≥ 1.25 D astigmatism in either eye, ≥ 1.00 D SE anisometropia
- •Astigmatism axis within ±10 degrees if magnitude is ≤1.00 D and within ±5 degrees if >1.00 D
排除标准
- •• No previous treatment for CI
- •No previous diagnosis of CI from an ophthalmologist or optometrist
- •No medications known to affect accommodation or vergence
- •Investigator & patient willing to forgo all other CI treatment other than that assigned by randomization
研究组 & 干预措施
Immediate Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)
16 sessions, twice per week of office-based vergence/accommodation therapy (OBVASM)While OBVAM therapy retains the essential elements of OBVAT. The OBVAM therapy protocol has four phases. Phase 1 targets visual/vestibular issues typical in mTBI-CI by integrating version eye movements, such as saccades and pursuits, with head and body movements. It also includes gross convergence, monocular accommodative (focusing) flexibility, and simple convergence procedures. The subsequent phases concentrate on enhancing ramp vergence amplitudes and improving accommodative facility (Phase 2), focusing on vergence facility and endurance (Phase 3), and integrating vergence and accommodation (Phase 4). Head and body movements are incorporated into some therapy procedures in Phases 3 and 4.
干预措施: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) (Other)
Delayed Office-Based Vergence/Accommodative Therapy with Movement (OBVAM)
Same as immediate group but delayed 6 weeks
干预措施: Office-Based Vergence/Accommodative Therapy with Movement (OBVAM) (Other)
结局指标
主要结局
Clinical Composite Measure
时间窗: 6 weeks
The primary outcome measure is a composite score of two key clinical measures: the near point of convergence (NPC) and positive fusional vergence at near (PFV). At the two outcome visits, each participant's performance on these clinical measures will be categorized according to the following predefined success criteria: 1) Successful: meets both criteria; a) NPC is \<6 cm and improved ≥4 cm and b) PFV meets Sheard's criterion and the blur (break, if no blur) is \>15Δ and increased ≥10Δ; 2) Improved: NPC improved ≥4 cm and PFV improved ≥10Δ; and 3) Non-Responder: Does not meet criteria for successful or improved
次要结局
- Comparison of the Change in the Near Point of Convergence (NPC) break and recovery value(6 weeks)
- Comparison of the Change in Positive Fusional Vergence after 6 weeks between the Two Groups(6 weeks)