Oslo University Hospital
Oslo, 0424, Norway
Location contact
Amanda Schjetlein, M.D.
CONTACT
Erlend C. S. Landsend, M.D., Ph.D.
CONTACT
NCT Number: NCT07427719
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).
Trial opening soon.
Get Notified6 year–20 year
All sexes
Observational
Oslo, 0424, Norway
Amanda Schjetlein, M.D.
CONTACT
Erlend C. S. Landsend, M.D., Ph.D.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Amanda Schjetlein, M.D.
CONTACT
Erlend Christoffer Sommer Landsend, M.D., Ph.D.
CONTACT
Oslo University Hospital
Other
Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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