The Emmetropization Via Accommodation (EVA) - II Study (EVA-II)
To determine if wearing a novel treatment during a 15-month period will enhance emmetropization in 4-month-old infants who have demonstrated poor ocular accommodation (eye focusing).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Uncorrected hyperopia (farsightedness) in children can lead to significant learning and visual problems, affecting their overall well-being and academic potential. Normally, infants are born with a moderate degree of hyperopia which should decrease as undergo a normal, developmental process called emmetropization, which mostly occurs during the first 18 months of life. Sometimes, this process fails, leaving children with higher-than-normal levels of hyperopia, which significantly increases their risk of developing conditions like strabismus (crossed eyes), amblyopia (lazy eye), and early literacy and scholastic issues. Infants who are at the greatest risk of not undergoing the normal emmetropization process are those with significantly higher levels of hyperopia early in infancy and those with poor ocular accommodation. The emmetropization process is not perfectly understood in human infants but may allow a window of opportunity for early intervention to help reduce the risk of debilitating vision conditions, while the visual system is still plastic. This study seeks to determine if early intervention, specifically partial refractive correction and visual engagement exercises (meant to stimulate ocular accommodation), can help improve the accommodative response and therefore reduce hyperopia in infants at high risk of not undergoing emmetropization. By treating 4-month-old infants with poor accommodation, the study aims to facilitate emmetropization and potentially reduce the risk of long-term visual problems. The study will also explore whether hyperopic defocus or accommodative effort is the primary signal guiding emmetropization, the two major theories of human emmetropization. Positive outcomes from this research could lead to new standards of care for hyperopic infants, potentially preventing a lifetime of vision-related issues and improving early literacy and academic performance.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ann M Morrison, OD, PhD
- Número de teléfono: 614-247-0010
- Correo electrónico: morrison.421@osu.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43209
- The Ohio State University College of Optometry
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Contacto:
- Ann M Morrison, OD, PhD
- Número de teléfono: 614-247-0010
- Correo electrónico: morrison.421@osu.edu
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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:
- Signed parental permission and HIPAA authorization and willingness to comply with study procedures.
- Infant 13-19 weeks of age at baseline.
- Either sex and any race or ethnicity.
- Good general health based on parent-provided history, normal pregnancy and delivery without serious complications, and birthweight >2500 g.
- Mean MEM accommodative lag >+1.25 D based on three measurements throughout the baseline examination.
- Cycloplegic spherical-equivalent hyperopia ≥+3.50 D in one or both eyes.
Exclusion Criteria:
- Astigmatism >2.00 D in either eye.
- Anisometropia >1.50 D spherical equivalent.
- Strabismus.
- Previous difficulty with pupil dilation.
- Cardiac, liver, asthma, or other respiratory disease.
- Ocular disease/abnormality, prior intraocular surgery, retinal detachment, optic nerve hypoplasia, malformation of the eye, cortical visual impairment, or active ocular inflammation.
- Hydrocephalus, Down syndrome, cerebral palsy, severe developmental delay, or seizure disorder.
- A condition preventing spectacle wear for the study duration (e.g., plagiocephaly).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Observation
No treatment is administered in this arm. |
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|
Experimental: Spectacles and At-Home Therapy
Participants will receive experimental treatment. |
Infants will receive spectacles that have a prescription relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D from the study protocol. An experimental non-invasive treatment will be prescribed as well. Treatment will continue until study completion at 18 months of age or until the infant reaches a spherical equivalent refractive error of +2.00D or less hyperopia. Participants will also receive a non-invasive treatment to be used at home. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ocular Accommodation measured with MEM
Periodo de tiempo: 14 months
|
Change in accommodative lag (in Diopters), measured with Monocular Estimation Method (MEM). |
14 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation between refractive error and ocular accommodation measured with MEM
Periodo de tiempo: 14 months
|
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with MEM retinoscopy, in Diopters (D) |
14 months
|
|
Correlation between refractive error and ocular accommodation measured with PowerRefractor
Periodo de tiempo: 14 months
|
Refractive error will be measured using retinoscopy, in Diopters (D) and ocular accommodation will be measured with the PlusOptix PowerRefractor, in Diopters (D) |
14 months
|
Colaboradores e Investigadores
Patrocinador
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
- 20261737
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.
producto fabricado y exportado desde los EE. UU.
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