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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07427719
Enrollment
140
Registered
2026-02-23
Start date
2026-04-01
Completion date
2029-06-01
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Retinopathy of Prematurity, Treatment, Laser, anti-vascular endothelial growth factor, Visual field defect, Cerebral visual impairment, Refractive errors, Prematurity

Brief 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.

Interventions

None listed

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Width of the foveal avascular zoneFrom date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 yearsWidth of the foveal avascular zone in micrometers measured with optical coherence tomography angiography
Choroidal vascularityFrom 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 thicknessFrom 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 retinaFrom 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 fieldFrom 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

Secondary

MeasureTime frameDescription
Correlation between cerebral visual impairment and brain hemorrhagesNeonatal period to time for data collection in the current studyCorrelation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period
Visual acuityFrom 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.

Countries

Norway

Contacts

CONTACTErlend Christoffer Sommer Landsend, M.D., Ph.D.
erllan@ous-hf.no0047 91 50 27 70
CONTACTAmanda Schjetlein, M.D.
amasch@ous-hf.no0047 91 50 27 70
STUDY_CHAIRErlend Christoffer Sommer Landsend, M.D., Ph.D.

Oslo University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026