Retinopathy of Prematurity - Visual Function and Retinal Structure
Retinopathy of Prematurity (ROP) · Prematurity Complications · Cerebral Visual Impairment · Visual Field Defect
De qué trata este estudio
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- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 6 años - 20 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 140 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.
In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
Leer la descripción completa
Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). The risk of ROP increases with lower gestational age and birth weight of the child. In a child born pre-term the blood vessels in the retina may not be fully developed. New - but unstructured - vessels could grow up from the retina and lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) into the eye has become more common.
In this study, the researchers aim to explore whether treatment of ROP affects visual function and retinal development. To investigate this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).
The participants will undergo a comprehensive eye examination, including imaging of the retina, visual field testing, and biometric measurements. Their parents will also answer questions regarding cerebral visual impairment.
Results from the group not treated for ROP will be compared to the treated subjects. Data will also be correlated with non-ocular parameters, such at gestational age, birth weight and brain hemorrhages.
¿Quién podría participar?
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Inclusion criteria:
- Patients treated for ROP with either laser or injection of A-VEGF.
- Patients previously diagnosed with ROP but not treated for the condition.
Exclusion criteria:
- Age below six years at date of examination.
- A developmental level not compatible with performing the study examinations.
- Patients born or treated outside Norway
- Known ocular or systemic disease that can give structural or functional changes in the retina.
Población del estudio
- Group 1: patients treated for ROP with laser
- Group 2: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 1)
- Group 3: patients treated for ROP with injection of A-VEGF
- Group 4: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 3)
Tratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
Laser treated
Subjects treated for ROP with laser of avascular retina
Control laser treated
Control subjects matched with subjects treated with laser
A-VEGF treated
Subjects treated for ROP with intravitreal injection of A-VEGF
Control A-VEGF treated
Control subjects matched with subjects treated with A-VEGF
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Width of the foveal avascular zone
Plazo: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years
Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography
Choroidal vascularity
Plazo: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent
Retinal nerve fiber layer thickness
Plazo: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography
Length of persistent avascular retina
Plazo: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography
Width of the visual field
Plazo: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Width of the visual field in degrees measured with Goldmann Perimetry
Medidas secundarias
Correlation between cerebral visual impairment and brain hemorrhages
Plazo: Neonatal period to time for data collection in the current study
Correlation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period
Visual acuity
Plazo: From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.
Visual acuity measured with LogMAR.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Oslo University HospitalOslo, Oslo, NorwayEstado desconocido
Equipo y fechas
- Patrocinador principal
- Oslo University Hospital
- Inicio del estudio
- 1 ene 2027 Estimado
- Finalización primaria
- 1 ene 2028 Estimado
- Finalización del estudio
- 1 jun 2029 Estimado
- Primera publicación
- 23 feb 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026