NCT07427719

Retinopathy of Prematurity - Visual Function and Retinal Structure

Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Retinopathy of Prematurity (ROP)
• Prematurity Complications
• Cerebral Visual Impairment
• Visual Field Defect

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-01-01
• Completion: 2029-06-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Norway