- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07839091
Comparing Myopia Control Spectacle Lenses and Standard Single Vision Spectacle Lenses in Children With Myopia (PEARL)
A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R&D Centre, Singapore.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Thomas Boudenne
- Correo electrónico: thomas.boudenne@essilor.com
Copia de seguridad de contactos de estudio
- Nombre: Celine Carimalo
- Número de teléfono: +65 67134617
- Correo electrónico: carimalc@essilor.com.sg
Ubicaciones de estudio
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Singapore, Singapur
- Essilor R&D Centre Singapore
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Contacto:
- Celine Carimalo
- Número de teléfono: +65 67134617
- Correo electrónico: carimalc@essilor.com.sg
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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:
- Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- Informed consent of parent/guardian and assent of participant.
- Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
- Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
- Be in good general health, based on the participant and the parent's/guardian's knowledge.
- Agree to wear the study spectacles for 12 hours per day and 7 days per week.
- Agree not to be involved in other myopia control treatments.
Exclusion Criteria:
- History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
- Strabismus by cover test at near or distance wearing correction.
- History and presence of amblyopia.
- Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- History of ocular injury or surgery.
- Participation in any clinical study within 30 days of the Baseline visit.
- Current or anticipated use of growth hormones.
- Study participants deemed inappropriate for the study by the investigator.
- The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: OD: SVL; OS: MCL then OD: MCL; OS: SVL
Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
A spectacle lens designed to help slow the progression of myopia in children A standard spectacle lens used to correct refractive error without a specific myopia control feature |
|
Experimental: OD: MCL; OS: SVL then OD: SVL; OS: MCL
Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months. |
A spectacle lens designed to help slow the progression of myopia in children A standard spectacle lens used to correct refractive error without a specific myopia control feature |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in Eye Axial Length
Periodo de tiempo: From baseline to 6 months
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From baseline to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Eye Axial Length
Periodo de tiempo: From 6 months to 12 months
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From 6 months to 12 months
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Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Periodo de tiempo: From baseline to 6 months
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From baseline to 6 months
|
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Change in Eye Non-Cycloplegic Spherical Equivalent Refraction
Periodo de tiempo: From 6 months to 12 months
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From 6 months to 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew Tan, Essilor R&D Centre Singapore
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- WS10528
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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