UNITY DX Cornea Study
12 de agosto de 2026 actualizado por: Alcon Research
UNITY DX Cornea Precision and Agreement Study
The purpose of this study is to validate the clinical measurement performance of an investigational biometer.
Subjects will undergo multiple measurements of the eye, and the agreement, repeatability, and reproducibility of corneal and epithelial thickness maps will be evaluated.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
The study population will consist of male and female adult subjects with normal corneas (approximately 30 subjects), keratoconus (approximately 20 subjects), prior corneal laser vision correction (approximately 20 subjects), current and habitual contact lens wear (approximately 20 subjects), and dry eye (approximately 20 subjects).
In this single visit study, measurements will be taken by 3 different operators using their own set of devices (configuration), UNITY DX and ANTERION.
Each subject's participation is expected to last approximately 3 hours with a planned duration of exposure generally not longer than 10 minutes per device.
Only one eye (designated as the study eye) will be enrolled per subject.
Tipo de estudio
De observación
Inscripción (Estimado)
110
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.
Estudio Contacto
- Nombre: Alcon Call Center
- Número de teléfono: 1-888-451-3937
- Correo electrónico: alcon.medinfo@alcon.com
Ubicaciones de estudio
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84107
- The Eye Institute of Utah
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Cohorts will be selected from approximately one investigative site located in the United States.
Descripción
Key Inclusion Criteria:
- Able to understand and sign an Institutional Review Board approved informed consent form.
- Willing and able to attend all scheduled study visits as required per protocol.
- Identified by the investigator as having normal corneas or abnormal corneas per protocol-specified criteria.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Unable to fixate due to nystagmus or other eye movement abnormality, such as significant strabismus.
- Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study.
- Active ocular infection or inflammation.
- Other protocol-specified exclusion criteria may apply.
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Normal Corneas
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with normal corneas.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Keratoconus
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with keratoconus.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Prior Corneal Laser Vision Correction
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with prior corneal laser vision correction.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Current and Habitual Contact Lens Wear
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with current and habitual contact lens wear.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
|
Dry Eye
The eye will be imaged up to seven times with each biometer to achieve three acceptable scans.
This cohort will enroll subjects with dry eye.
|
Investigational non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
Commercially available non-contact, non-invasive ophthalmic imaging and analysis device used for visualization of ocular structures and their optical properties
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean corneal thickness
Periodo de tiempo: Day 1
|
Corneal thickness will be measured by the device and reported in microns.
This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
|
Day 1
|
|
Mean epithelial thickness
Periodo de tiempo: Day 1
|
Epithelial thickness will be measured by the device and reported in microns.
This outcome measure will be analyzed using Bland-Altman Limits of Agreement, Deming regression, repeatability and reproducibility.
|
Day 1
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trial Lead, Surgical, Alcon Research, LLC
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 (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de agosto de 2026
Publicado por primera vez (Actual)
17 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CTK378-C003
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.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .