Functional Assessments in Vision Impairment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Retinitis Pigmentosa (RP), Diabetic Retinopathy (DR), Age Related Macular Degeneration (AMD), Glaucoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австралия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Novel Approach for Capturing Real-world Functional Assessment Outcomes in Participants With a Vision Impairment
Обзор
The aim of the research project is to validate the use of a novel functional assessment tool designed to document how participants with a vision impairment complete activities of daily living in a real world environment.
Подробное описание
There is currently no multisensory tool to assess functional vision in people with a vision impairment. This study is designed to capture and assess the reliability and validity of a novel tool developed by multi-disciplinary experts in ophthalmology, optometry, orthoptics, orientation and mobility (O\&M) specialists, and people with lived experience of low vision. The tool is designed to be used in both clinical and in interventional clinical trial setting, to provide functional vision assessment measures within real-world outcomes. The development of this tool is at a critical junction in time where a range, of interventions are being developed for people with low vision including bionic eyes, and gene and cell therapies. The FDA requires trials to show real world functional outcomes in addition to traditional endpoints, hence a tool like the ATOMM may have wide use and implications. This study will recruit participants with varying levels of vision impairment to assess the reliability of the ATOMM.
Первичные конечные точки
- Evaluating validity and reliability [Срок оценки: From enrolment to assessment could range from 2 to 4 weeks.]
Критерии участия
Критерии включения
- Willing to provide signed informed consent.
- Be available for study visits.
- Willing to comply with study assessments.
- In good general health and ambulant.
- Aged over 18 years of age.
- Have a vision impairment caused by any ocular condition which affects independent mobility.
- Agree to allow the research team into their home and local environments.
- Participate in assessments in public settings
Критерии исключения
- Significant co-morbidities which prohibit involvement in study visits.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- Cognitive deficiencies, including dementia or progressive neurological disease.
- Have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder.
- Deafness or significant hearing loss.
- Inability to converse in English.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Австралия · 1 центр
- Centre for Eye Research Australia — Melbourne
Идентификаторы
NCT: NCT06908161 · 24/1642H