Retinopathy of Prematurity - Visual Function and Retinal Structure
Retinopathy of Prematurity (ROP) · Prematurity Complications · Cerebral Visual Impairment · Visual Field Defect
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 6 years - 20 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 140 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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).
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Study population
- Group 1: patients treated for ROP with laser
- Group 2: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 1)
- Group 3: patients treated for ROP with injection of A-VEGF
- Group 4: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 3)
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Laser treated
Subjects treated for ROP with laser of avascular retina
Control laser treated
Control subjects matched with subjects treated with laser
A-VEGF treated
Subjects treated for ROP with intravitreal injection of A-VEGF
Control A-VEGF treated
Control subjects matched with subjects treated with A-VEGF
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
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
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
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
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 measures
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
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Oslo University HospitalOslo, Oslo, NorwayStatus unknown
Study team and timeline
- Lead sponsor
- Oslo University Hospital
- Study start
- Jan 1, 2027 Estimated
- Primary completion
- Jan 1, 2028 Estimated
- Study completion
- Jun 1, 2029 Estimated
- First posted
- Feb 23, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026