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NCT Number: NCT07427719

Retinopathy of Prematurity - Visual Function and Retinal Structure

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Width of the foveal avascular zone

    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

  2. Choroidal vascularity

    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

  3. Retinal nerve fiber layer thickness

    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

  4. Length of persistent avascular retina

    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

  5. Width of the visual field

    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

Secondary outcomes

  1. Correlation between cerebral visual impairment and brain hemorrhages

    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

  2. Visual acuity

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Schjetlein, M.D.

CONTACT

[email protected]

0047 91 50 27 70

Erlend Christoffer Sommer Landsend, M.D., Ph.D.

CONTACT

[email protected]

0047 91 50 27 70

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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