VisionApp - Ghosting
Assessment of the Accuracy and Repeatability of the VisionApp - Ghosting Measurement Protocol
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).
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Pete Kollbaum, PhD
- Номер телефона: 812-555-5500
- Электронная почта: kollbaum@iu.edu
Места учебы
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Indiana
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Bloomington, Indiana, Соединенные Штаты, 47405
- Рекрутинг
- Clinical Optics Research Lab
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Контакт:
- Pete Kollbaum, PhD
- Электронная почта: kollbaum@iu.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
MyDay is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a MyDay contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
NaturalVue is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a NaturalVue contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
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.)
|
|
Активный компаратор: 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.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
MyDay is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a MyDay contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
NaturalVue is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a NaturalVue contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
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.)
|
|
Активный компаратор: 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.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
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.)
MiSight 1 Day is a commercially available multifocal soft contact lens for daily wear.
Children participants will assess images for ghosting while wearing a MiSight 1 Day contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
An investigational multifocal soft contact lens for daily wear.
While the contact lens is made of an FDA approved material which is already marketed in the United States, it differs from commercially available lenses in that it has a slightly different optical design.
Children participants will assess images for ghosting while wearing this investigational contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
|
|
Активный компаратор: 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.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
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.)
MiSight 1 Day is a commercially available multifocal soft contact lens for daily wear.
Children participants will assess images for ghosting while wearing a MiSight 1 Day contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
An investigational multifocal soft contact lens for daily wear.
While the contact lens is made of an FDA approved material which is already marketed in the United States, it differs from commercially available lenses in that it has a slightly different optical design.
Children participants will assess images for ghosting while wearing this investigational contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Ghosting Quantification
Временное ограничение: Day 1
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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. |
Day 1
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 12501b
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .