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Evaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System

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Qué se está recopilando

Colección de datos

Quiénes están siendo reclutados

Catarata

+ Enfermedades Oculares

+ Enfermedades del Cristalino

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Cómo está diseñado el estudio

Observacional
Inicio del estudio: febrero de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Eye Institute (NEI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de febrero de 2004

Fecha en la que se inscribió al primer participante.

Standardized lens photography with centralized grading of photographs has been used in clinical trials and epidemiologic studies of cataract. While photographic grading systems have been shown to be reliable, they are too expensive and complex to use in many studies. For some large studies, especially those with many centers or those in which lens changes are of secondary concern, it would be useful to have a simple clinical lens grading system that is reliable and that can be used with minimal training of examiners. Several clinical lens grading systems have been developed and found to be reliable in the hands of dedicated lens researchers, but the systems have been difficult for other ophthalmologists to use reliably. The Age-Related Eye Disease Study (AREDA) has developed a simplified clinical cataract grading system to assess the severity of nuclear, cortical and posterior subcapsular cataracts, the 3 main types of age-related cataract. The system is designed to require minimal examiner training for persons already proficient in the use of the slit lamp. A total 150 participants with cataracts of varying severity, who are already participating in other NEI protocols, will be recruited to evaluate the reliability of the system. After being dilated, each participant will have a lens grading performed independently by 2 examiners. To provide information on the validity of the clinical gradings, lens photographs will be taken and graded using the detailed AREDS system for grading photographs. The data will allow us to evaluate (1) the agreement between the AREDS clinical lens grading system and the AREDS photographic system of grading lens opacities, and (2) the agreement on assessment of cataract severity among opthalmologists (with varying subspecialty) using the AREDS clinical lens grading method.

Título OficialEvaluation of the Age-Related Eye Disease Study (AREDS) Clinical Lens Grading System 
NCT00078299
Patrocinador PrincipalNational Eye Institute (NEI)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 150 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

CatarataEnfermedades OcularesEnfermedades del Cristalino

Criterios

INCLUSION CRITERIA: 1. Patient must understand and sign the informed consent. 2. Patient must be at least 18 years of age. 3. Pupillary dilation to at least 6 mm must be possible. 4. Patients must have at least one natural lens present. EXCLUSION CRITERIA: Patients below the age of 18 will be excluded from participation in this study of age-related cataract. 1. Any condition such as corneal opacification that precludes adequate slit lamp examination and photography of the lens.

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

National Eye Institute (NEI)

Bethesda, United StatesVer ubicación
Completado1 Centros de Estudio