Retinopathy of Prematurity - Visual Function and Retinal Structure

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-20
SponsorOslo University Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients treated for ROP with either laser or injection of A-VEGF.

Patients previously diagnosed with ROP but not treated for the condition.

Disqualifiers

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.

Trial 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)

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 4 trial groups
Group A: Laser treated
Group B: Control laser treated
Group C: A-VEGF treated
Group D: Control A-VEGF treated

Trial outcomes

Primary outcomes

1

Width of the foveal avascular zone

Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography

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
2

Choroidal vascularity

Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent

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.
3

Retinal nerve fiber layer thickness

Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography

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.
4

Length of persistent avascular retina

Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography

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.

Secondary outcomes

1

Correlation between cerebral visual impairment and brain hemorrhages

Correlation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period

Time frame
Neonatal period to time for data collection in the current study
2

Visual acuity

Visual acuity measured with LogMAR.

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.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: