Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle (CZV_PAL1)
17 de abril de 2017 actualizado por: Meng C. Lin, University of California, Berkeley
The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each.
All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned.
At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance.
Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.
Tipo de estudio
Intervencionista
Inscripción (Actual)
95
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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California
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Berkeley, California, Estados Unidos, 94720-2020
- Clinical Research Center, School of Optometry, University of California, Berkeley
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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
39 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Presbyope
- Experienced PAL spectacle wearer
- Correctable to at least 20/25 in both eyes
- Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction
- Able and willing to complete all laboratory measurements and questionnaire batteries
Exclusion Criteria:
- Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center
- Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study
- Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Randomized Order of Interventions 1
Randomized to first wear standard, non-free-form, non-customized PAL spectacles, then second, crossover to wear individually customized free-form surfaced PAL spectacles
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Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Otros nombres:
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Comparador activo: Randomized Order of Interventions 2
Randomized to first wear individually customized free-form surfaced PAL spectacles, then second, crossover to wear standard, non-free-form, non-customized PAL spectacles
|
Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual Acuity, High Contrast, Distance Chart
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
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Visual Acuity, Low Contrast, Distance Chart
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
|
Visual Acuity, High Contrast, Near Chart
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
|
Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
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Visual Acuity, Low Contrast, Near Chart
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
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30-degree Off-axis Distance Visual Acuity, High Contrast Chart
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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30-degree Off-axis Distance Visual Acuity, Low Contrast Chart
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
|
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Horizontal Extent of Undistorted Vision at Reading Distance
Periodo de tiempo: Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid
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Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles
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Questionnaire Battery
Periodo de tiempo: At study exit, after both Test and Control spectacles had been worn for 1 week each
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Forced-choice Likert scale preference questionnaire
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At study exit, after both Test and Control spectacles had been worn for 1 week each
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meng C. Lin, OD, PhD, Clinical Research Center, School of Optometry, University of California, Berkeley
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de febrero de 2009
Finalización primaria (Actual)
1 de octubre de 2009
Finalización del estudio (Actual)
1 de octubre de 2009
Fechas de registro del estudio
Enviado por primera vez
3 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
3 de noviembre de 2010
Publicado por primera vez (Estimar)
4 de noviembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
17 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CZV_PAL1
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