An observational study in Retinopathy of Prematurity (ROP), Prematurity Complications and Cerebral Visual Impairment, sponsored by Oslo University Hospital. Not yet recruiting at 1 site in Norway. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Oslo University Hospital · Observational
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).
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.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's planned enrollment of 140 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
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Exclusion criteria:
Subjects treated for ROP with laser of avascular retina
Control subjects matched with subjects treated with laser
Subjects treated for ROP with intravitreal injection of A-VEGF
Control subjects matched with subjects treated with A-VEGF
Width of the foveal avascular zone
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
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
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
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
Width of the visual field in degrees measured with Goldmann Perimetry
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.
Correlation between cerebral visual impairment and brain hemorrhages
Correlation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period
Time frame: Neonatal period to time for data collection in the current study
Visual acuity
Visual acuity measured with LogMAR.
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.
Plan to share: Undecided — Awaits allowance to share IPD from the Regional committees for medical and health research ethics.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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