Glaucoma Screening to Enhance At-Risk Californians' Health

Официальное название

Novel Telehealth Technologies to Detect and Manage Glaucoma and Vision-threatening Eye Diseases in High-risk Populations

Обзор

The vast majority of glaucoma cases in the United States go undetected and untreated until the late stages of the disease. Open-angle glaucoma is a progressive condition that is asymptomatic in its early to moderate stages and may be amenable to screening through telemedicine-based approaches. This study is a randomized trial to evaluate whether glaucoma screening with established tests (e.g., optical coherence tomography, fundus photography, and tonometry) is more effective for detecting undiagnosed glaucoma cases compared to education alone or delayed intervention.

Подробное описание

Specific Aim 1: To determine the effectiveness of a telemedicine-based glaucoma screening program for detecting glaucoma. The investigators hypothesize that a mobile screening intervention incorporating optical coherence tomography (OCT), fundus photography, and tonometry will result in a greater number of new glaucoma diagnoses compared to education alone or delayed treatment.

Specific Aim 2: To determine whether a telemedicine-based glaucoma screening program provides benefits beyond glaucoma detection. The investigators hypothesize that (A) individuals randomized to the screening intervention will have higher rates of cataract surgery and distance vision correction one year after screening, and (B) those in the screening intervention will report higher vision-related quality of life one year after screening.

Вмешательства

• Другое Glaucoma screening with optical coherence tomography (OCT), color fundus photography, and tonometry
  Participants will be called and offered a screening appointment. At the appointment, visual acuity, OCT, color fundus photography, tonometry, and visual field testing will be performed. The images will be assessed for abnormalities. Participants meeting referral criteria will be referred for a comprehensive eye examination with an eye care provider.
• Другое Educational Brochure
  A brochure about glaucoma screening will be mailed to participants. The brochure will include contact information of a staff member who can schedule an appointment for a comprehensive eye examination.

Первичные конечные точки

• Glaucoma Diagnosis or Glaucoma Suspect Requiring Treatment [Срок оценки: 3 months from randomization]

Вторичные конечные точки (3)

• Cataract surgery [Срок оценки: 12 months]
• Eyeglasses [Срок оценки: 12 months]
• Quality of Life survey [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Black people aged 50 years or older
• Hispanic people aged 65 years or older
• People with diabetes aged 50 years or older
• Must have been seen at the Federally Qualified Health Center (FQHC) within the past month

Критерии исключения

• Patients without a valid phone number or mailing address
• Patients who have had an optometry appointment within the past year

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

Скрининг

Центры проведения

США · 2 центра

• Baywell Health — Oakland
• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06854198 · 24-43132 · U01DP006820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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