Retinopathy of Prematurity - Visual Function and Retinal Structure

February 16, 2026 updated by: Erlend Christoffer Sommer Landsend, Oslo University Hospital

Children Treated for Retinopathy of Prematurity - Study of 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).

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Erlend Christoffer Sommer Landsend, M.D., Ph.D.
  • Phone Number: 0047 91 50 27 70
  • Email: erllan@ous-hf.no

Study Contact Backup

  • Name: Amanda Schjetlein, M.D.
  • Phone Number: 0047 91 50 27 70
  • Email: amasch@ous-hf.no

Study Locations

  • Norway
    • Oslo County
      • Oslo, Oslo County, Norway, 0424
        • Oslo University Hospital
        • Contact:
          • Amanda Schjetlein, M.D.
          • Phone Number: 0047 91 50 27 70
          • Email: amasch@ous-hf.no
        • Contact:
          • Erlend C. S. Landsend, M.D., Ph.D.
          • Phone Number: 0047 91 50 27 70
          • Email: erllan@ous-hf.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Neonatal period to time for data collection in the current study
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.
From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Study Chair: Erlend Christoffer Sommer Landsend, M.D., Ph.D., Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 927328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Awaits allowance to share IPD from the Regional committees for medical and health research ethics.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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