Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes
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
- В протоколе указаны: Establishment of a vision center.
- Кому может быть актуально
- Состояния в реестре: Cataract Surgery, Eye Care, Glasses, Primary Eye Care. Базовые параметры: Без ограничений · 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
- США
- 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 Cluster-Randomized Trial Evaluating the Effect of Vision Centers on Access to Eye Care and Eye Health Outcomes in South Asia
Обзор
This cluster-randomized trial aims to evaluate the effect of vision centers on access to eye care and eye health outcomes in South Asia. The main questions it aims to answer are: 1. Do vision centers improve effective refractive error coverage? 2. Do vision centers increase eye care center utilization? 3. Do vision centers improve population visual acuity? Researchers will compare outcomes in communities randomized to immediate versus delayed establishment of a vision center. Outcomes will be assessed through population-based surveys at baseline and after two years as well as through hospital records collected throughout the study period.
Подробное описание
The vast majority of visual impairment and blindness is preventable or treatable with existing interventions. Nearly all of this burden is faced by those living in low- and middle-income countries. Access to eye care is a key challenge in these settings, particularly in rural and remote areas.
Vision centers (VCs) have been developed to increase access to primary eye care in such underserved settings. VCs typically involve establishment of a fixed center staffed by a mid-level ophthalmic technician who offers refraction, spectacles, diagnosis and treatment of basic eye conditions, and referrals for more complex care. VCs have become a common approach to increase access to care in many low- and middle-income country settings, yet little rigorous evidence exists on their impact on eye health in the communities they serve. A recent literature review was unable to identify randomized controlled trials on the impact of vision centers on eye health outcomes in real world settings. While the observational research that exists suggests VCs improve eye health in the communities they serve, the existing evidence is prone to bias.
The investigators propose a cluster-randomized trial to evaluate the effect of VCs on access to eye care and eye health outcomes in South Asia. The trial will leverage VCs planned by the Seva Foundation and partners Bangladesh, India, and Nepal and will monitor outcomes via population-based surveys and hospital network records over 2 years. The investigators expect to provide rigorous evidence on VC impact in real-world settings that can be used to influence programmatic decision making and policy.
Вмешательства
- Другое Establishment of a vision center
The establishment of a vision center includes building a fixed center, and equipping it with a trained vision technician to provide basic eye care services such as refractive error correction, spectacle dispensing, basic diagnosis for common conditions, as well as referrals for advanced care at base hospitals. The establishment of VCs will be actively publicized in the neighboring communities through promotion by local stakeholders, teachers, community workers, village leaders, health workers, a
Первичные конечные точки
- Effective refractive error coverage [Срок оценки: 2 years]
Вторичные конечные точки (10)
- Prevalence of eyecare visits [Срок оценки: 1 year]
- Mean presenting and pinhole visual acuity [Срок оценки: 2 years]
- Near vision effective refractive error coverage [Срок оценки: 2 years]
- Effective cataract surgical coverage [Срок оценки: 2 years]
- Prevalence of current spectacle ownership [Срок оценки: 2 years.]
- Prevalence of spectacle wearing [Срок оценки: 2 years]
- Prevalence of visual impairment [Срок оценки: 2 years]
- Prevalence of blindness [Срок оценки: 2 years]
- Prevalence of employment [Срок оценки: 2 years]
- Prevalence of individuals with caregiving responsibilities for visually impaired household members [Срок оценки: 2 years]
Критерии участия
Критерии включения
- The catchment area of the proposed VC site is predominantly rural.
- The proposed VC site is located within 20-100 km of the base hospital.
- There are no major primary eye care services within 10 km of the proposed site.
- Care at sites randomized to establish VCs immediately is accessible to anyone.
Критерии исключения
- Sites located in non-rural or urban catchment areas.
- Sites outside the 20-100 km distance range from the base hospital.
- Sites with existing major primary eye care services within a 10 km radius.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- University of California, San Francisco — San Francisco
Идентификаторы
NCT: NCT07227714 · 25-45086