Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract (Comparison)
24 de marzo de 2020 actualizado por: Rupert Menapace, Medical University of Vienna
The rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam.
The investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power.
Measurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices
Descripción general del estudio
Estado
Desconocido
Intervención / Tratamiento
Descripción detallada
The rationale of this study is to compare repeatability, reproducibility and agreement of both, AS-OCT(s) and Pentacam.
In our department three different AS-OCT devices and a HR Scheimpflug imaging device are currently in use for clinical routine to measure the cornea.
Among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature.
The four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist.
One advantage of ASOCT represents faster imaging speed when compared to Scheimpflug imaging.
Thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by AS-OCT.
Chen et al demonstrated that HR Scheimpflug imaging measurements of CCT were systematically higher than the measurements provided by FD AS-OCT.
Further, repeatability, reproducibility and agreement of AS-OCT and Scheimpflug imaging device will be assessed during follow-up.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Vienna, Austria, 1090
- Reclutamiento
- Medical University of Vienna Allgemeines Krankenhaus
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Contacto:
- Rupert Menapace, Prof.
- Número de teléfono: 014040066300
- Correo electrónico: rupert.menapace@meduniwien.ac.at
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Contacto:
- Christina Leydolt, MD
- Número de teléfono: 79480 01 40400
- Correo electrónico: christina.leydolt@meduniwien.ac.at
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 95 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age-related cataract
- Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Exclusion Criteria:
- Contact lens wear within 5 days
- Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination
- History of corneal ocular surgery
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: IOL Master® 700
Biometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Comparador activo: Pentacam®
Keratometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Comparador activo: Casia II®
Keratometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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Comparador activo: Spectralis Anterion®
Biometry will be performed three times consecutively.
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Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
Patients will be asked to place the chin in position and open their eyes wide.
In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Agreement of the four devices measuring mean keratometry value.
Periodo de tiempo: 1 year
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The measured K-Value of each device and the k-values within one device will be compared
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Agreement of the four devices measuring mean steep keratometry value.
Periodo de tiempo: 1 year
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The measured steep K-Value of each device and the steep k-values within one device will be compared
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1 year
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Agreement of the four devices measuring mean flat keratometry value.
Periodo de tiempo: 1 year
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The measured flat K-Value of each device and the flat k-values within one device will be compared
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1 year
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Agreement of the four devices measuring mean true keratometry value.
Periodo de tiempo: 1 year
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The measured true K-Value of each device and the true k-values within one device will be compared
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1 year
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Agreement of the devices measuring mean axial length
Periodo de tiempo: 1 year
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The measured axial length of each device and the axial length within one device will be compared
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1 year
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Agreement of the devices measuring mean lens thickness
Periodo de tiempo: 1 year
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The measured lens thickness of each device and the measured lens thickness within one device will be compared
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1 year
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Agreement of the devices measuring mean white-to-white measurement
Periodo de tiempo: 1 year
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The measured white-to-white distance of each device and the measured white-to-white distance within one device will be compared
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1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Rupert Menapace, MD, Medical University of Vienna
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de marzo de 2020
Finalización primaria (Anticipado)
30 de julio de 2020
Finalización del estudio (Anticipado)
30 de julio de 2020
Fechas de registro del estudio
Enviado por primera vez
17 de marzo de 2020
Primero enviado que cumplió con los criterios de control de calidad
24 de marzo de 2020
Publicado por primera vez (Actual)
26 de marzo de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
24 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1845/2019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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