Assessment of the Accuracy and Repeatability of the VisionApp - Ghosting Measurement Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ghosting Quantification
研究概览
简要总结
Recent Android mobile device technology is available which allows user-measured refractive error and reading add power. This technology could be quite useful to the clinical and research community. The current study aims to evaluate the accuracy, repeatability, and reproducibility of one such technology by VisionApp, specifically with regard to ghosting vision.
VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc).
详细描述
Subjects will be enrolled at the Clinical Optics Research Lab at Indiana University.
At the study visit, demographic and health/ocular history may be collected by oral history and standard clinical testing including refraction (check of glasses prescription), auto-refraction or abbrerometry may be performed. Visual acuity and room lighting checks may also be measured using standard clinical techniques.
For the experimental portion of the study visit, participants will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales, while wearing different contact lenses. Participants will first be asked to wear commercially available single vision contact lenses to establish best corrected vision. A single vision lens will then remain in one eye, and participants will proceed with ghosting assessments using two different multifocal contact lenses worn in the other eye. Adult participants will perform the ghosting assessments while wearing 2 commercially available multifocal lenses, and children participants will perform the ghosting assessments while wearing a commercially available and investigational lens. Randomization will determine which lens is worn first.
If participants are unable to complete all testing in a single session, they may be permitted to return on a subsequent day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •has a refractive error between Plano and -5.00 D of sphere and cylinder components combined.
- •has refractive cylinder (e.g., astigmatism) of -0.75 D or less
- •has had a self-reported oculo-visual exam in the last 2 years
- •has best-corrected visual acuity of at least 20/20 in each eye
- •is not amblyopic or does not have any diagnosed ocular disease
- •is willing and able to follow instructions and maintain the appointment schedule
排除标准
- •has any systemic disease affecting ocular health and visual acuity
- •is currently using any systemic or topical medications that could affect ocular health and visual acuity
- •is participating in another eye related research study
研究组 & 干预措施
Adults: Lens 1, then Lens 2
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: Proclear 1 Day Contact Lens (Device)
Adults: Lens 1, then Lens 2
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: MyDay Contact Lens (Device)
Adults: Lens 1, then Lens 2
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: NaturalVue Contact Lens (Device)
Adults: Lens 1, then Lens 2
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: VisionApp (Device)
Adults: Lens 2, then Lens 1
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: Proclear 1 Day Contact Lens (Device)
Adults: Lens 2, then Lens 1
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: MyDay Contact Lens (Device)
Adults: Lens 2, then Lens 1
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: NaturalVue Contact Lens (Device)
Adults: Lens 2, then Lens 1
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: VisionApp (Device)
Children: Lens 3, then Lens 4
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: Proclear 1 Day Contact Lens (Device)
Children: Lens 3, then Lens 4
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: MiSight 1 Day Contact Lens (Device)
Children: Lens 3, then Lens 4
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: VisionApp (Device)
Children: Lens 4, then Lens 3
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: Proclear 1 Day Contact Lens (Device)
Children: Lens 4, then Lens 3
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: MiSight 1 Day Contact Lens (Device)
Children: Lens 4, then Lens 3
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales. This will be performed twice, while wearing two different soft multifocal contact lenses in one eye. The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized. After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
干预措施: VisionApp (Device)
结局指标
主要结局
Ghosting Quantification
时间窗: Day 1
Ghosting quantification (e.g. how "doubled" the image looks) will be compared against expected template images and those predicted. Subjects will provide a quality rating of ghosting on a scale between 0 - 100, with lower scores indicating more ghosting of the image and 100 representing an optically perfect image. The VisionApp will also model ghosting measurements for direction, separation, blur and strength into a predictive quality rating, which will be compared to the subject's subjective expected, or overall, quality rating.
次要结局
未报告次要终点
研究者
Pete Kollbaum, OD, PhD
Professor
Indiana University