Validation of the Vision Trainer Clinical Decision-Support Software
Validation of the Vision Trainer Clinical Decision-Support Software:A Randomized Comparison of Software-Guided Subjective Refraction(JCC and Non-JCC Algorithms) Against Unassisted Manual Refraction
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Pennsylvania Presbyterian Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Provision of signed and dated informed consent form prior to any study procedures.
- Age ≥18 years at the time of informed consent.
- Best corrected visual acuity (BCVA) of at least 20/40 in both eyes, measured with current spectacle or contact lens correction.
- Able to provide informed consent in English.
- Willing and able to complete an approximately 25-30-minute study visit
- No significant ocular pathology or media opacity that would preclude accurate standard refraction.
Exclusion Criteria:
- Ocular pathology significantly affecting visual function: untreated or advanced glaucoma, advanced age-related macular degeneration, proliferative diabetic retinopathy with vision loss, current retinal detachment, or other posterior segment disease materially impairing BCVA.
- Recent ocular surgery within the prior 6 months, including refractive surgery (LASIK, PRK, SMILE, phakic IOL), cataract surgery, or other intraocular procedures.
- Spherical equivalent refractive error exceeding ±12 Diopters.
- Any medical condition or circumstance that, in the judgment of the Investigator, would preclude safe or valid participation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Randomized 1:1
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实验性的：Treatment Arm
Receive the Vision Training Softward
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Participants will receive the vision software trainer when randomized 1:1
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1st Outcome Measure
大体时间：Baseline
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To demonstrate non-inferiority of Vision Trainer software-guided refraction (JCC and Non-JCC workflows combined) versus unassisted standard manual refraction in terms of prescription accuracy. Two co-primary effectiveness endpoints are defined at the eye level. The first endpoint is the signed difference in Mean Spherical Equivalent (MSE), calculated as $$D_{MSE} = \text{MSE}_{software} - \text{MSE}_{unassisted}$$. The second endpoint is astigmatic component accuracy, computed as signed Thibos power-vector component differences: $$D_{J0} = J_{0,software} - J_{0,unassisted}, \quad D_{J45} = J_{45,software} - J_{45,unassisted}$$. |
Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Secondary Outcome Measure
大体时间：Baseline
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Time-to-completion for software-guided vs. unassisted refraction
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Baseline
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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