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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 1st Outcome Measure
研究概览
简要总结
This study is a prospective, randomized, crossover clinical investigation designed to evaluate the accuracy, efficiency, and usability of the Vision Trainer software for subjective refraction. The study compares software-guided refraction, implemented using both Jackson Cross Cylinder (JCC) and Non-JCC workflows, against standard unassisted manual refraction performed by trained examiners
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Randomized 1:1
Treatment Arm
Receive the Vision Training Softward
干预措施: Software Trainer (Device)
结局指标
主要结局
1st Outcome Measure
时间窗: Baseline
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: $$D\_{J0} = J\_{0,software} - J\_{0,unassisted}, \\quad D\_{J45} = J\_{45,software} - J\_{45,unassisted}$$.
次要结局
- Secondary Outcome Measure(Baseline)
研究者
Fareedah Haroun
Director, Contact Lens Service, Department of Ophthalmology Division Chief, Optometry Services
University of Pennsylvania