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 volunteersQualifiers
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
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Width of the foveal avascular zone
Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography
Choroidal vascularity
Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography
Length of persistent avascular retina
Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography
Secondary outcomes
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
Visual acuity
Visual acuity measured with LogMAR.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: