- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05194657
Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ
Assessment of Reading Performance in Patients With Acrysof IQ Vivity Toric or Non-toric vs Monofocal Acrysof IQ Toric or Non-toric IOL
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
With increasing demands of patients concerning their visual function after cataract surgery, a variety of advanced technology intraocular lenses (IOL) have become available in the last years. Various developments aim at a reduced spectacle independence for patients after cataract or refractive lens surgery.
Novel technology for providing an extended depth of focus (EDOF) has been developed to account for unmet needs of patients. A novel EDOF IOL, the Acrysof IQ Vivity, has two surface transition elements that work simultaneously by stretching and shifting the wavefront to create a continuous extended focal range instead of multiple focal points.
To assess the performance of such an IOL technology, most studies assess visual acuity at different distances from far, to intermediate up to near. Since most activites with digital devices implicate reading, it is not surprising that reading difficulty is the most common complaint among individuals experiencing visual disturbances with multifocal designs.
Reading ability is usually evaluated using various reading tests that assess reading speed and reading acuity defined as the print size that can stell be read with sufficient speed. However, one of the fundamental problems of these tests is that reading speed is also influenced by the average amount of time that a patient reads as well as the language of the text, whether it is the first or second language.
A novel method to analyse reading performance that appears to be more objective and less reliant on the cognitive abilities of the patient is the observation of the reading pattern using a high-speed eye-tracking system that analyses eye fixations during the reading test. In previous studies we have seen that several aspects of this reading patter, i.e. fixation duration and fixation frequency, appear to correlate with the reading performance overall and can be differentially used to discriminate between cognitive and visuo-motor processing.
Hence, the aim of this study is to assess the visual function and reading performance with an EDOF IOL (Acrysof IQ Vivity) compared to a standard monofocal IOL (Acrysof IQ).
136 eyes of 68 patients will be included into this study. According to the randomization, 34 patients will be implanted with the Acrysof IQ Vivity in both eyes and the other 34 patients will be implanted with the Acrysof IQ in both eyes. A follow-up examination will be performed at 3 months postoperative. During this visit a slitlamp examination, biometry and tomography of the eye, refraction and visual acuity assessment, an OCT examination, a retroillumination photogrypha, reading speed analysis and halometry will be performed.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Natascha Bayer, MSc
- Número de teléfono: 57564 01 91021
- Correo electrónico: office@viros.at
Copia de seguridad de contactos de estudio
- Nombre: Sahand Amir-Asgari, MD
- Número de teléfono: 57564 01 91021
- Correo electrónico: office@viros.at
Ubicaciones de estudio
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Vienna, Austria, 1140
- Reclutamiento
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
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Contacto:
- Natascha Bayer, MSc
- Número de teléfono: 57564 01 91021
- Correo electrónico: office@viros.at
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Contacto:
- Sahand Amir-Asgari, MD
- Número de teléfono: 57564 01 91021
- Correo electrónico: office@viros.at
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Cataract
- Stereopsis
- age 21 and older
- regular corneal astigmatism of up to 3.0 D
- written informed consent prior to surgery
- normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- availability, willingness and sufficient cognitive awareness to comply with examination procedures
- german as mother-tongue
- calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)
Exclusion Criteria:
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
- amblyopia
- contact lenses
- irregular corneal astigmatism on corneal topography
- postoperative subjective refraction smaller/ higher than or 0.75 D
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Acrysof IQ Vivity
Patient will receive the enhanced depth of focus IOL during cataract surgery
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Acrysof IQ Vivity, enhanced depth of focus IOL
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Experimental: Acrysof IQ
Patiet will receive the monofocal IOL during cataract surgery
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Acrysof IQ, monofocal IOL
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Reading speed
Periodo de tiempo: 24 months
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reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Visual acuity
Periodo de tiempo: 24 months
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Visual acuity will be assessed using the ETDRS charts and will be compared between the EDOF IOLs and the monofocal IOLs
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24 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Vivity
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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